10 TTA
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• Age: 44.8 ± 13.5 yr
• Gender: M = 10, F = 0
• Weight: 77 ± 17.9 kg
• TSA: 7.1 ± 6.6 yr
• MFCL: K2–K3
• AB-control group: Y/N
• Cause of amputation: TR = 4, VA = 5, TU = 1
Passive vs passive
• SACH (P)
• Talux (P)
• Single axis (P)
1 weekStanding
Standing on BSS platform in 3 conditions (with rigid, compliant & unstable surface) for 20 s per condition
Biomechanical
• Overall stability index
• Anterior stability index
• Posterior stability index
• Medial stability index
• Lateral stability index
• OSI, APSI, and MLSI indices were not affected by the interaction between prosthetic foot types and surface conditions
• OSI ↑ using Talux ↔ SACH on foam surface ↔ firm and unstable support surface (p = 0.04)
• Trend of stability indexes: lowest for SACH foot and highest for Talux foot in most of the conditions
Arifin et al. 2014b10 TTA
• Age: 44.8 ± 13.5 yr
• Gender: M = 10, F = 0
• Weight: 77 ± 17.9 kg
• TSA: 7.1 ± 6.6 yr
• MFCL: K2–K3
• AB-control group: Y/N
• Cause of amputation: TR = 4, VA = 5, TU = 1
Passive vs passive
• SACH (P)
• Talux (P)
• Single axis (P)
2 weeksStanding
Standing on BSS platform in two conditions (eyes open & eyes closed) for 20 s per condition
Biomechanical
• Overall stability index
• Anterior stability index
• Posterior stability index
• Medial stability index
Subjective
• ABC-scale
• Control of postural steadiness unaffected by type of prostheses
• MLSI > APSI for Talux in both eyes-opened and eyes-closed conditions (p = 0.034 and p = 0.017, respectively)
• OSI, APSI and MLSI score > during eyes-closed ↔ eyes-opened condition for all foot types. Differences between the two conditions were only statistically significant in OSI (p = 0.018) and MLSI (p = 0.018) for SACH foot, as well as in OSI (p = 0.043) and APSI (p = 0.027) for Talux foot
• ABC-scale: differences occurred between Talux and SACH (p = 0.043) as well as Talux and single axis foot (p = 0.028)
Childers et al. 20185 TTA
• Age: 44 ± 13.9 yr
• Gender: –
• Weight: 80.5 ± 13.9 kg
• TSA: 11.2 ± 5.3 yr
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: –
Passive vs passive
• Proflex (P)
• Variflex (P)
5 minTreadmill slope walking
1 min of level, incline and decline walking at 1.1 m/s
Biomechanical
• Foot angle
• Prosthetic ankle and foot power
• Whole body COM rate of energy change
• Range of motion ↑ with Pro-Flex foot
• Energy return ↑ with Pro-Flex foot
• Energy return from Pro-Flex foot ↓ ↔ sound limb ankle–foot system
• Energy from Pro-Flex foot affected whole body COM mechanics
• ↓ loading on sound limb = unclear
D'Andrea et al. 20148 TTA
• Age: 47 ± 8 yr
• Gender: M = 8, F = 0
• Weight: 98.6 ± 9.7 kg
• TSA: 19.4 ± 11.8 yr
• MFCL: ≥ K3
• AB-control group: Y/N
• Cause of amputation: TR = 8
Active vs passive
• Biom prototype (A)
• Participants’ current prosthesis (P)
1 session with Biom of at least 2 hLevel walking
Walking 3 times at 0.75, 1.00, 1.25, 1.50, and 1.75 m/s along 10-m walkway
Biomechanical
• Whole-body angular momentum
During the affected leg stance phase
• Sagittal whole-body angular momentum ranges > passive prostheses ↔ active prosthesis at 1.25 m/s (ES = 0.25; CI = 0.039–0.047, 0.037–0.045; p = 0.032) and 1.50 m/s (ES = 0.22; CI = 0.034–0.042, 0.031–0.039; p = 0.032)
During the unaffected leg stance phase:
• Sagittal whole-body angular momentum ranges > passive prosthesis at 0.75 m/s (ES = 0.33; CI = 0.046–0.060, 0.042–0.054; p = 0.031) and 1.75 m/s (ES = 0.33; CI = 0.023–0.031, 0.019–0.027; p = 0.017) ↔ active prosthesis
• No differences in frontal whole-body angular momentum ranges between prostheses. no differences in transverse H at any speed, except for 0.75 m/s, transverse H range > passive prosthesis ↔ active prosthesis (ES = 0.11; CI = 0.016–0.026, 0.015–0.025; p = 0.040)
Darter et al. 20146 TTA
• Age: 30 ± 4 yr
• Gender: M = 5, F = 1
• Weight: 85.4 ± 16.9 kg
• TSA: 2.8 ± 1.2 yr
• MFCL: ≥ K2
• AB-control group: Y/N
• Cause of amputation: –
Quasi-passive vs passive
• Proprio (QP)
• Participants’ current prosthesis (P)
3 weeksTreadmill slope walking
Walking at 3 speeds (0.89, 1.11, and 1.34 m/s) at each of three slope conditions (− 5°, 0°, and 5°)
Physiological
• VO2
Subjective
• RPE
• EE for walking with the current foot was 13.5% > for slope descent ↔ Proprio (on-mode) (p < 0.05) and 10.3% more than with the Proprio (off-mode) (p < 0.05)
• No differences were found for EE during level walking and slope ascent
• Mean energy cost values ↓ (improved economy) as speed ↑ during slope descent and level grade walking
• Prosthetic foot type = significant (p < 0.01) during slope descent → less-economical gait with current prosthesis ↔ Proprio devices [Proprio (on-mode) 14.0%, p < 0.01, Proprio (off-mode) 10.5%, p < 0.05] but no differences between Proprio (on-mode) and Proprio (off-mode)
• Perceived difficulty of walking ↑ as walking speed ↑ with significant device effect for slope descent (p < 0.01). RPE values ↓ with the Proprio (on-mode) by an average of 2.2 on the 6–20 scale ↔ current prosthesis (p < 0.01) and 1.8 with the Proprio (off-mode) ↔ current prosthesis (p < 0.01)
Davot et al. 20215 TTA
• Age: 37.2 ± 15.2 yr
• Gender: M = 4, F = 1
• Weight: 76.2 ± 12.2 kg
• TSA: 3.4 ± 2.2 yr
• MFCL: ≥ K2
• AB-control group: Y/N
• Cause of amputation: –
Quasi-passive vs passive
• Proprio (QP)
• Meridium (QP)
• Elan (QP)
• Participants’ current prosthesis (P)
2 weeksLevel walking + slope walking
3 walking conditions at SS speed: on level ground, on a 12% (7°) ramp ascent and on a 12% (7°) ramp descent of 6.2 m long
Biomechanical
• ROM
• Equilibrium point
• Hysteresis (= net energy loss of the system, computed on the entire gait cycle)
• Late stance energy released
• Quasi-stiffness
• ROM = Elan lowest maximal dorsiflexion in ascent (9°) and maximal plantarflexion in descent (12°). Dorsiflexion differences Meridium ↔ Elan (p = 0.008) and ↔ ESR (p = 0.0027). In every situation, the highest ROM was observed with the Meridium (mean = 19.5° in descent, 20.5° on level ground, 22.6° in ascent) and the lowest ROM with the Elan (mean = 18.9° in descent, 18.9° on level ground and 13.9° in ascent)
• Equilibrium point of current prosthesis was similar in the three conditions (no shift of the curve along the X axis). For the Elan, the equilibrium point was not shifted for the first characteristic pattern. For the proprio, a shift could be observed between level ground and ascent; for the Meridium, between level ground and descent + between level ground and ascent
• Hysteresis = Proprio and the current prosthesis presented lowest hysteresis in all conditions. The Meridium hysteresis was 2–3 times higher ↔ other 3 feet (p = 0.001)
• Elan: the energy released was the lowest in descent and the highest in ascent. On level ground, it was ↑ ↔ descent and↓ ↔ ascent. Meridium had the lowest energy for propulsion
• Quasi-stiffness = no differences between devices
De Asha et al. 201411 TTA
7 TFA
• Age: 45 ± 12.4 yr
• Gender: –
• Weight:
• TTA: 84.5 ± 17.0 kg
• TFA: 86.3 ± 15.3 kg
• TSA: 14.5 ± 14.4 yr
• MFCL: ≥ K3
• AB-control group: Y/N
• Cause of amputation: TR = 16, TU = 3
Passive vs passive
• Echelon (P)
• Participants’ current prosthesis (P)
No familiarisationLevel walking
Walking 8 m–walkway at SS speed
Biomechanical
• COM
• COP
• Swing time
• Stance time
• Inter-limb asymmetry
• Step length
Performance
• Speed
• Walking speed = ↑ with Echelon and ↑ for TTA ↔ TFA
• Aggregate negative CoP displacement was ↓ with Echelon. The CoP passed anterior to the shank earlier in stance with the Echelon
• Instantaneous COM speed at intact-limb TO was unchanged across foot conditions but instantaneous COM speed minimum during the subsequent prosthetic-limb single support phase was ↑ using the Echelon. As a result, there was less slowing of COM speed (walking speed) during prosthetic-limb single support for both groups when using the Echelon ↔ current prosthesis. Peak COM speed during prosthetic limb stance was unchanged across foot conditions. All instantaneous COM speed values were ↑ for TTA ↔ TFA (p ≤ 0.045)
• Swing time was longer for the prosthetic limb ↔ intact-limb and the differences between limbs was ↑ for TFA ↔ TTA
• Stance time ↑ intact-limb ↔ prosthetic-limb & differences between limbs ↑ TFA ↔ TTA
• Step length ↑ prosthetic limb ↔ intact limb
• There were no effects of foot condition (p = 0.84) or group (p = 0.063) on cadence. There were no effects of foot condition on inter-limb asymmetry in swing time, stance time or step length. Swing and stance time inter-limb asymmetry were ↑ TFA ↔ TTA but there was no group effect on step length inter-limb symmetry
De Pauw et al. 20186 TTA
6 TFA
• Age:
• TTA: 54 ± 14 yr
• TFA: 53 ± 14 yr
• Gender: M = 11, F = 1
• Weight:
• TTA: 80 ± 13 kg
• TFA: 89 ± 16 kg
• TSA: –
• MFCL: K2–K4
• AB-control group: Y/N
• Cause of amputation: –
Quasi-Passive vs passive
• AMP-foot 4.0 (QP)
• Participants’ current prosthesis (P)
No familiarisationTreadmill walking
6-min treadmill walking at SS speed, 2-min slow and 2 min fast walking
Physiological
• HR
• MV
• VO2
• VCO2
• RQ
• METS
Subjective
• QUEST
• RPE
• At normal speed, no significant differences between groups for MV, VO2, VCO2, RQ, and METS. In TTA, RQ ↑ with AMPfoot ↔ current prosthesis (p = 0.017). At other walking speeds, no differences were found
• HR = At fast speed, no differences. At slow speed, HR ↑ in TFA and TTA with AMPFoot ↔ current prosthetic device. In TFA, HR ↑ with current prosthesis and AMP-foot ↔ able-bodied individuals (p = 0.043 and 0.008, respectively). At other speeds, no significant differences were revealed
• At normal speed, RPE levels ↑ in TFA and TTA with current prosthesis and AMPFoot ↔ able-bodied individuals at the first (p ≤ 0.016 and p ≤ 0.004) and sixth minute (p ≤ 0.003 and p ≤ 0.004, respectively). No differences were observed between TFA and TTA when wearing the current prosthesis. RPE ↑ with AMPFoot in TFA ↔ TTA (p = 0.027). At slow and fast walking speeds, RPE ↑ for TFA and TTA ↔ able-bodied individuals for current prosthesis and AMPfoot (slow speed: p ≤ 0.004 and p ≤ 0.003, respectively; fast speed: p ≤ 0.005 and p ≤ 0.009, respectively). No differences in RPE were observed between TFA and TTA. In addition, at fast speed RPE ↓ in TTA ↔ TFA with AMPFoot (p = 0.042). In TFA, RPE levels were ↑ with AMPFoot ↔ current prosthesis at 1 and 6 min (p = 0.027 and 0.042, respectively)
• QUEST = 10 participants responded positive regarding buying the device if it was available on the market. Only in TFA, significant lower values for satisfaction and weight of AMPFoot ↔ current prosthesis were observed (p = 0.038 and 0.042, respectively)
De Pauw et al. 20196 TTA
6 TFA
• Age:
• TTA: 54 ± 14 yr
• TFA: 53 ± 14 yr
• Gender: M = 11, F = 1
• Weight:
• TTA: 80 ± 13 kg
• TFA: 89 ± 16 kg
• TSA: –
• MFCL: K2–K4
• AB-control group: Y/N
• Cause of amputation: –
Quasi-Passive vs passive
• AMP-foot 4.0 (QP)
• Participants’ current prosthesis (P)
No familiarisationTreadmill walking
Sustained Attention to Response Task, 6-min walking at SS speed + sustained attention to response task, 2-min walking at SS speed
Physiological
• MRCP
Performance
• Dual-task accuracy
• Dual-task walking: reaction times ↑ for TFA with AMPfoot ↔ AB individuals (p = 0.020). During walking with AMPfoot significant accuracy differences of the no-go stimuli at the middle and end part of the cognitive task were observed
• MRCP: no differences for MRCP amplitude and latency measures at electrode Cz between AB individuals and TTA walking with the current or novel prosthetic device. TFA walking with AMPfoot did not exhibit MRCPs, but TFA walking with the current prosthesis showed MRCPs at different electrode locations. No differences in activity of the brain sources of the different MRCP peaks were observed when TTA walked with the current and novel prosthetic device. Additionally, no significant differences were observed when TTA walked with the current prosthetic device ↔ AB individuals. On the other hand, ↔ AB individuals TTA wearing the AMPfoot showed ↑ activity of brain sources at the first positive deflection
De Pauw et al. 20206 TTA
6 TFA
• Age:
• TTA: 54 ± 14 yr
• TFA: 53 ± 14 yr
• Gender: M = 11, F = 1
• Weight:
• TTA: 80 ± 13 kg
• TFA: 89 ± 16 kg
• TSA: –
• MFCL: K2–K4
• AB-control group: Y/N
• Cause of amputation: –
Quasi-Passive vs passive
• AMP-foot 4.0 (QP)
• Participants’ current prosthesis (P)
No familiarisationTreadmill walking
2-min walking at SS speed, 2 min at slow (− 25% self-selected) and 2 min at fast (+ 25% self-selected) speeds. 1 min rest in between tasks
Biomechanical
• LE joint angles
• LE angular velocities
• Stride length
• Step width
• Maximum GRF
Performance
• Speed
• TFA did not benefit from walking with the novel prosthesis
• TTA walking at slow and normal speed with AMPfoot 4.0 → beneficial effects at the level of the ankle and knee
• No differences between walking with the current prostheses and AMPfoot 4.0 with respect to force platform data
Delussu et al. 201620 TTA
• Age: 66.6 ± 6.7 yr
• Gender: M = 17, F = 3
• Weight: 78.5 ± 13.2 kg
• TSA: –
• MFCL: K1–K2
• AB-control group: Y/N
• Cause of amputation: TR = 6, VA = 13, TU = 1
Passive vs passive
• 1M10 (P)
• SACH (P)
30 daysLevel walking
6MWT along 30-m-long linear course
Physiological
• MV
• VO2
• RER
• HR
• REI
• Energy cost
Performance
• SS speed
Subjective
• RPE
• Satisfaction
• No differences for MV, VO2, RER, HR and REI using SACH or 1M10
• Energy cost, SS speed, RPE score and SATPRO improved with the 1M10 compared to the SACH
Esposito et al. 2014a10 TTA
• Age: 30.2 ± 5.3 yr
• Gender: M = 9, F = 1
• Weight: 95.8 ± 7.3 kg
• TSA: –
• MFCL: ≥ K3
• AB-control group: Y/N
• Cause of amputation: TR = 10
Active vs passive
• BiOM (A)
• Participants’ current prosthesis (P)
3 weeksLevel walking
Walked at 3 controlled speeds
Biomechanical
• GRF
• Knee joint moments
• Loading rate
Subjective
• Rating of ambulation ability
Performance
• Speed
• The active prosthesis did not ↓ sound limb’s peak adduction moment or its impulse, but did ↓ the external flexor moment, peak vertical force and loading rate as speed ↑
• The active prosthesis ↓ loading rate from AB controls. The sound limb did not display a greater risk for knee osteoarthritis ↔ intact limb or ↔ AB controls in either device
• Self-selected walking speeds were not significantly different between prosthesis conditions
• Subject rating of ambulation ability using the PEQ was high in both devices
Esposito et al. 2014b6 TTA
• Age: 23 ± 5 yr
• Gender: M = 5, F = 1
• Weight: 91.4 ± 12.1 kg
• TSA: –
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: TR = 6
Active vs passive
• BiOM (A)
• Participants’ current prosthesis (P)
3 weeksLevel walking + slope walking
Walking at standardized speed (± 5) over level ground and inclined walkway + 6MWT on treadmill until steady state metabolic rate was achieved for both level and inclined walking
Biomechanical
• Step-to-step transition work
• LE joint angles
• LE joint moments
• LE joint power
Physiological
• Metabolic rate
• Kinetics & kinematics: during level walking, the BiOM ↑ peak ankle plantarflexion angles and powers at push-off ↔ current prosthesis and ↓ peak internal plantar flexor moments. During inclined walking, peak angles and powers ↑ in the BiOM. Peak ankle plantarflexion angles and powers ↓ in current prosthesis ↔ AB controls over level ground, and angles, moments, and powers ↓ on the incline. The BiOM normalized the peak ankle plantarflexion angles on level ground, but moments remained ↓ and powers ↑ ↔ AB controls during level ground and inclined walking
• Metabolic rate: during level walking, VO2 was ↓ 16% with BiOM ↔ current prosthesis. ↑ 9% metabolic rates with current prosthesis ↔ able-bodied individuals, but BiOM normalized metabolic rates. On the incline, metabolic rates were not different between BiOM ↔ AB controls or between BiOM ↔ current prosthesis
• Step-to-step transition = During level walking, the net step-to-step transition work prosthetic limb ↑ 63% with active ↔ current prosthesis. Active prosthetic trailing limb step-to-step transition work ↑28% ↔ AB controls, while current prosthesis ↓ 22% ↔ AB controls
• Net leading limb work during step-to-step transitions inclined walking ↑ 53% with active prosthesis ↔ current. Net trailing limb step-to-step transition work did not differ between AB controls and TTA
Ferris et al. 201211 TTA
• Age: 29.8 ± 5.3 yr
• Gender: M = 10, F = 1
• Weight: 95 ± 7.3 kg
• TSA: –
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: TR = 11
Active vs passive
• BiOM (A)
• Participants’ current prosthesis (P)
3 weeksLevel walking + agility and mobility
Walking at SS and controlled speed + T-test, Four square step test, Hill and stair Assessment Tests
Biomechanical
• GRF
• Symmetry
• Stance time
• Swing time
• Cadence
• Step length
• Stride length
• LE joint angles
• LE joint moments
• LE joint powers
Performance
• Agility and mobility
• Speed
Subjective
• User satisfaction
• Ankle ROM 30% > active prosthesis ↔ AB current, both < ROM ↔ AB control and intact limbs
• Peak ankle power ↓ 40% current prosthesis ↔ active
• Peak knee power ↑ 35% active prosthesis ↔ AB control ↑ 125% current → active absorbing 2 × the peak knee power observed in AB control and intact limbs
• Peak hip power ↑ 45% active prosthesis ↔ intact limb
• Walking speed ↑ active prosthesis ↔ current (not significant) ↔ AB control group
• User satisfaction scores → preference for active over current prosthesis
Gailey et al. 201210 TTA
• Age:
• Group 1: 60.6 ± 2.3 yr
• Group 2: 51 ± 5.8 yr
• Gender: M = 9, F = 1
• Weight:
• Group 1: 105.5 ± 6.4 kg
• Group 2: 92.1 ± 9.7 kg
• TSA:
• Group 1: 2.90 ± 1.8 yr
• Group 2: 16.1 ± 17.6 yr
• MFCL: K2–K3
• AB-control group: Y/N
• Cause of amputation: TR = 5, VA = 5
Quasi-Passive vs passive
• SACH (P)
• SAFE foot (P)
• Talux (P)
• Proprio (QP)
• Participants’ current prosthesis (P)
2 weeksLevel walking
Performing LCI-5, 6MWT
Performance
• LCI-5
• 6MWT
• Steps/day
• AMPRO
• Hours of daily activity
Subjective
• PEQ-13
• PEQ-13, LCI-5, 6MWT, or step activity monitor: no differences between devices
• AMPPRO: differences following training with the existing prosthesis in group 1 and between selected feet from baseline testing (p ≤ 0.05). Sign differences were found between group 1 and group 2 (p ≤ 0.05) in the AMPPRO and 6MWT when using the Proprio foot
• Self-report measures were unable to detect differences between prosthetic feet
Gardinier et al. 201710 TTA
• Age: 46.6 ± 15 yr
• Gender: M = 10, F = 0
• Weight: 93.2 ± 17.9 kg
• TSA: –
• MFCL: K3–K4
• AB-control group: Y/N
• Cause of amputation: TR = 9, VA = 1
Active vs passive
• BiOM (A)
• Participants’ current prosthesis (P)
8 minTreadmill walking
Walking along 8-m walkway at at SS speed and controlled speed + walking 8-min on treadmill until steady-state energy expenditure is reached
Physiological
• Energetic cost
• VO2
• Cost of transport
Performance
• Speed
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• No sign differences in VO2 (2.9% difference; P = 0.606, d = 0.26) using the active ankle ↔ current prosthesis
• No sign differences in cost of transport (1% difference; P = 0.652, d = 0.23) using the active ankle ↔ current prosthesis
• No sign differences in preferred walking speed (1% difference; P = 0.147, d = 0.76) using the active ankle ↔ current prosthesis
• Participants classified as having the highest function (MFCL = K4) were sign more likely to exhibit energy cost savings ↔ those classified as having lower function (K3; P = 0.014, d = 2.36)
Gates et al. 201311 TTA
• Age: 30 ± 5 yr
• Gender: M = 10, F = 1
• Weight: 95 ± 7.3 kg
• TSA: –
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: TR = 11
Active vs passive
• BiOM (A)
• Participants’ current prosthesis (P)
3 weeksWalking (rocky surface)
Walking across a loose rock surface at three controlled speeds; The rock surface was a 4.2-m long by 1.2-m wide by 10-cm deep pit filled with loose river rocks from a major hardware store
Biomechanical
• COM
• Minimum margin of stability
Performance
• Speed
• Walking speed ↑ 10% using active prostheses (1.16 m/s) ↔ current (1.05 m/s; p = 0.031)
• Ankle plantarflexion ↑ (p < 0.001), knee flexion ↓ (p = 0.045) on their prosthetic limb using active prostheses ↔ current
• Other kinematics of the knee and hip = nearly identical between devices
• Medial–lateral motion COM ↓ using active prosthesis ↔ current (p = 0.020),
• Medial–lateral margins of stability = no differences between devices (p = 0.662)
Grabowski et al. 20137 TTA
• Age: 45 ± 6 yr
• Gender: –
• Weight: 99.5 ± 10.2 kg
• TSA: 21.1 ± 11.3 yr
• MFCL: ≥ K3
• AB-control group: Y/N
• Cause of amputation: –
Active vs passive
• Active prototype (A)
• Participants’ current prosthesis (P)
2 hLevel walking
Walking at 0.75, 1.00, 1.25, 1.50, and 1.75 m/s along 10 m-walkway
Biomechanical
• GRF
• Knee joint moments
• Loading rates
• Active prosthesis ↓ unaffected leg peak resultant forces by 2–11% at 0.75–1.50 m/s ↔ current
• Active prosthesis ↓ first peak knee external adduction moments by 21 and 12% at 1.50 and 1.75 m/s ↔ current
• Loading rates = no differences between prostheses
Graham et al. 20076 TFA
• Age: 40.3 ± 6.3 yr
• Gender: –
• Weight: 88.5 ± 9.4 kg
• TSA: –
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: –
Passive vs passive
• VariFlex (P)
• Multiflex (P)
3–6 weeksLevel walking
Timed walking test along 207.3-m oval circuit including outdoor and indoor walking with the resultant variations of camber and surface
Biomechanical
• Step-length ratio
• Stance time
• Vertical GRF
• Ankle dorsiflexion
• Knee flexion
• Hip flexion/extension
• Transverse pelvic rotation
• Ankle power
• Hip power
Performance
• Speed
Subjective
• Prosthetic socket fit comfort score
• VariFlex speed ↑ + ↑ equal step lengths at fast speed ↔ multiflex
• VariFlex ↑ peak ankle dorsiflexion at push-off on the prosthetic side (18.3° + − 4.73°, P < 0.001) + ↑ 3 × power from the prosthetic ankle at push-off (1.13 + − 0.22 W/kg, P < 0.001) ↔ multiflex
• No sign differences in temporal symmetry or loading of the prosthetic limb, in the timed walking test with each foot, or in the comfort score
Graham et al. 20086 TFA
• Age: 40.3 ± 6.3 yr
• Gender: –
• Weight: 88.5 ± 9.4 kg
• TSA: –
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: –
Passive vs passive
• VariFlex (P)
• Mutliflex (P)
3–10 weeksTreadmill walking
2-min walking tests; Speeds increases every 2 min starting at 0.83 m/s then 0.94 m/s, 1.1 m/s, 1.25 m/s, 1.39 m/s, 1.53 m/s, 1.67 m/s and 1.81 m/s until subjects find the treadmill speed too fast
Physiological
• Mean VO2
Performance
• Speed
• VariFlex ↓ mean VO2 ↔ Multiflex at all speeds, although the differences were only sign at speeds of 0.83 and 1.1 m/s. The estimated differences across all speeds was 3.54 mL/kg minHeitzmann et al. 201811 TTA
• Age: 37.9 ± 12.3 yr
• Gender: M = 9, F = 2
• Weight: 81.1 ± 17.4 kg
• TSA: 11.9 ± 10.6 yr
• MFCL: K3–K4
• AB-control group: Y/N
• Cause of amputation: TR = 4, VA = 2, TU = 4, O = 1
Passive vs passive
• Proflex pivot (P)
• Participants’ current prosthesis (P)
30–45 minLevel walking
Walking along 10 m-walkway at SS speed
Biomechanical
• Ankle ROM
• Peak ankle moment, peak ankle power
• Peak external knee varus moment
• Peak vertical GRF
Performance
• Speed
• Proflex ↓ walking speed (1.33 ± 0.16 m/s) ↔ current prosthesis (1.39 ± 0.17 m/s). AB controls did not walk sign faster ↔ TTA
• Proflex ↑ prosthetic ankle ROM by 12.5° ↔ current prosthesis
• Angle ROM and peak dorsiflexion of 18.8° ↔ current prosthesis + no sign differences ↔ AB controls
• Peak external ankle dorsi-flexion moment < AB controls (proflex: 28%, current prosthesis: 36% + no sign differences in peak external ankle dorsi-flexion moment between prosthetic feet
• Peak positive ankle power < current prosthesis (by 66%) and Proflex (by 33%) ↔ AB controls + Proflex ↑ peak ankle power ↔ current prosthesis
• External knee varus moment and the peak vertical GRF for Proflex ↓ ↔ current prosthesis & AB controls
Houdijk et al. 201815 TTA
• Age: 58.8 ± 11.1 yr
• Gender: –
• Weight: 86 ± 12.6 kg
• TSA: –
• MFCL: K3
• AB-control group: Y/N
• Cause of amputation: TR = 12
Passive vs passive
• SACH (P)
• Variflex (P)
1 dayLevel walking
Walking along 10-m walkway at a fixed speed
Biomechanical
• Work
• Vertical COM
• Step length intact
• Step length symm
• Backward Margin of stability
• Push-off work ↑ Variflex ↔ SACH
• COM speed at toe-off ↑ Variflex ↔ SACH
• Intact step length and step length symmetry ↑ without ↓ the backward margin of stability Variflex ↔ SACH
Hsu et al. 20068 TTA
• Age: 36 ± 15 yr
• Gender: M = 8, F = 0
• Weight: 81.7 ± 9.6 kg
• TSA: –
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: –
Passive vs passive
• C-walk (P)
• Flex foot (P)
• SACH (P)
4 weeksTreadmill walking
2 min walking at SS speed
Physiological
• Gait efficiency
• VO2
• %APMHR
Performance
• Steps/day
Subjective
• RPE
• C-Walk had a trend of ↑ physiologic responses ↔ SACH
• Flex foot: no sign differences in EE and gait efficiency, but ↓ %APMHR & RPE ↔ C-Walk and SACH
Johnson et al. 201421 TTA
• Age: 48.2 ± 12.8 yr
• Gender: M = 18, F = 3
• Weight: 87.4 ± 13.2 kg
• TSA: 8.8 ± 14 yr
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: –
Passive vs passive
• Echelon (P)
• Participants’ current prosthesis (P)
45 minLevel walking
Walking along 8 m-walkway
Biomechanical
• MTC
• LE joint angles
• Prosthetic limb hip-hiking
Performance
• Speed
• Mean MTC ↑ on both limbs with Echelon ↔ current prosthesis (p = 0.03)
• Walking speed ↑ Echelon ↔ current prosthesis (p = 0.001) + ≈ ↑ swing-limb hip flexion on the prosthetic side Echelon ↔ current prosthesis (p = 0.04)
• Variability in MTC ↑ on the prosthetic side with Echelon (p = 0.03), but this did not ↑ risk of tripping
Prakash et al. 202015 TTA
• Age: 33.3 ± 5.5 yr
• Gender: –
• Weight: –
• TSA: –
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: –
Passive vs passive
• SACH (P)
• Passive prototype ESR (P)
15 minLevel walking
10‑m walk test + 5 min of strolling at SS speed
Biomechanical
• Stride length
• Cadence
Physiological
• PCI
Performance
• Speed
• Stride length, cadence, speed, and PCI ↓ SACH ↔ current prosthesisParadisi et al. 201520 TTA
• Age: 66.7 ± 6.7 yr
• Gender: M = 17, F = 3
• Weight: 78.7 ± 13.2 kg
• TSA: 9.8 ± 13.5 yr
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: TR = 6, VA = 13, O = 1
Passive vs passive
• 1M10 (P)
• SACH (P)
4 weeksLevel walking, slope walking and stair climbing
Performing 6MWT, LCI-5, HAI, SAI, BBS
Performance
• Score on BBS, LCI-5, HAI, SAI
• Time
• Speed
• Upright Gait Stability
Subjective
• PEQ
• Walking speed ↑ 1M10 ↔ SACH (p < 0.05) maintaining the same upright gait stability
• BBS, LCI-5, and SAI times and 4 of 9 subscales of the PEQ ↑ 1M10 ↔ SACH
Rábago et al. 201610 TTA
• Age: 30.2 ± 5.3 yr
• Gender: M = 9, F = 1
• Weight: 96.1 ± 6.8 kg
• TSA: –
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: –
Active vs passive
• BiOM (A)
• Participants’ current prosthesis (P)
3 weeksSlope walking
walking along 5 m long, 5˚ sloped ramp at controlled speed
Biomechanical
• GRF
• Stance time
• Step length
• Stride length
• Swing time
• LE joint angles
• LE joint moments and powers
• Second vertical peak
• Braking
• Propulsion
Performance
• Speed
• During slope ascent, the BiOM ↑ prosthetic ankle plantarflexion and push-off power generation ↔ current prosthesis + matched AB controls more closely
• Similar deviations and compensations between both feet
• Transitioning off the prosthetic limb → ↑ ankle plantarflexion and push-off power with BiOM → ↓ intact limb knee extensor power production → ↓ demand on the intact limb knee ↔ current prosthesis
Riveras et al. 202013 TTA
• Age: 38.2 ± 13.2 yr
• Gender: M = 10, F = 3
• Weight: 75.1 ± 15.4 kg
• TSA: 10.8 ± 13.1 yr
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: TR = 10, VA = 2, O = 1
Passive vs quasi-passive
• Esprit (P)
• Echelon (QP)
• Elan (QP)
1 hSlope walking
walking along 6 m, 5° inclination ramp at SS speed
Biomechanical
• Tripping probability
• Coefficient of variation
• Minimum toe clearance
• MTC median values for ascending (P ≤ 0.001, W = 0.58) and descending the ramp (P = 0.003, W = 0.47) in the prosthetic limb ↑ Elan ↔ Esprit and Echelon
• CV ↓ on the prosthetic limb for descending the ramp (P = 0.014, W = 0.45) using the Echelon and Elan ↔ Esprit
• Elan = Lowest TP for the prosthetic leg in three conditions evaluated
• On the sound limb results showed the median MTC was ↑ (P = 0.009, W = 0.43) and CV ↓ (P = 0.005, W = 0.41) during ascent using Echelon and Elan ↔ Esprit
Schmalz et al. 20194 TTA
• Age: 56 ± 12 yr
• Gender: M = 4, F = 0
• Weight: 79 ± 8.0 kg
• TSA: –
• MFCL: K3 – K4
• AB-control group: Y/N
• Cause of amputation: TR = 3, VA = 1
Passive vs quasi-passive
• Meridium (QP)
• Participants’ current prosthesis (P)
2 weeksSlope walking
Walking along circuit of 3 m downhill walkway (10° inclination) followed by specific uphill and downhill elements with opposite inclination angles of 10
Biomechanical
• GRF
• LE joint moments
• LE joint angles
• Meridium ↑ ankle adaptation to the abruptly changing inclination, reflected by a ↑ stance phase dorsiflexion ≈ to AB controls ↔ current prosthesis
• Peak value of the knee extension moment on the prosthetic side was ↑ with current prosthesis, whereas it was almost normal with Meridium (current prosthesis: 0.71 ± 0.13 Nm/kg, Meridium: 0.42 ± 0.12 Nm/kg, NA: 0.36 ± 0.07 Nm/kg, p < 0.05 and p < 0.01)
• External knee adduction moment was ↓ for TTA and did not show differences between prostheses
Segal et al. 20157 TTA
• Age: 52.3 ± 12 yr
• Gender: –
• Weight: 80.9 ± 9.9 kg
• TSA: –
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: TR = 7
Passive vs quasi-passive
• Participants’ current prosthesis (P)
• Lightfoot2 (P)
• Prototype: Controlled Energy Storage and Return prosthetic foot (QP)
5 minLevel walking
Walking on a treadmill at the target speed of 1.14 m/s for 10 min, until they reached steady state. + walking along a 10 m-walkway at same speed
Biomechanical
• GRF
• COM
• LE joint powers
• Work during gait
Physiological
• VO2
• ↑ energy storage during early stance, ↑ prosthetic foot peak push-off power and work, ↑ prosthetic limb COM push-off work and ↓ intact limb COM collision work with Controlled Energy Storage and Return prosthetic foot ↔ Lightfoot2 and current prosthesis
• Biological contribution of the positive COM work for Controlled Energy Storage and Return prosthetic foot was ↓ ↔ Lightfoot2 and current prosthesis
• Net metabolic cost for Controlled Energy Storage and Return prosthetic foot did not change comp ↔ Lightfoot2 and ↑ ↔ current prosthesis
Struckov et al. 20169 TTA
• Age: 41.2 ± 12.9 yr
• Gender: M = 9, F = 0
• Weight: 74.1 ± 15.7 kg
• TSA: –
• MFCL: K3
• AB-control group: Y/N
• Cause of amputation: –
Passive vs quasi-passive
• Elan (QP)
• Epirus (P)
20 minSlope walking
Ramp descent at slow and customary speed
Biomechanical
• Residual-knee loading, response flexion
• Single-support minimum flexion
• Time to foot flat
• CoP
• Prosthetic-limb shank mean angular velocity during single-support
• Single-support residual-knee moment impulse
• Single-support negative mechanical work at the residual hip and knee joints
• Unified deformable segment
• Foot-flat was attained fastest with the Epirus and second fastest with the Elan (P < 0.001)
• Prosthetic shank single-support mean rotation speed ↓ (p = 0.006), flexion (P < 0.001) ↓, negative work done at the residual knee (P = 0.08) ↓, and negative work done by the ankle–foot ↑ (P < 0.001) with Elan ↔ Epirus and Elan in off-mode
Underwood et al. 201211 TTA
• Age: 42.5 ± 13.5
• Gender: M = 8, F = 3
• Weight: 80.3 ± 14.3 kg
• TSA: 11.1 ± 13.3 yr
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: –
Passive vs passive
• FlexWalk (P)
• SAFE FOOT 2 (P)
30 minLevel walking
Walking along 10 m-walkway at SS speed
Biomechanical
• LE peak joint moments and power
• Perceived stability and mobility
• The majority of the kinetic differences that occurred due to the changing of prosthetic foot type were limited to ankle joint variables in the sagittal plane with ↑ peak moments and power during propulsion for the Flex foot ↔ SAFE foot
• Effects were also found at joints proximal to the prosthesis (e.g., knee) and differences were also found in the kinetics of the sound limb
Wezenberg et al. 201415 TTA
• Age: 55.8 ± 11.1 yr
• Gender: M = 15, F = 0
• Weight: 86 ± 12.6 kg
• TSA: –
• MFCL: –
• AB-control group: Y/N
• Cause of amputation: TR = 15
Passive vs passive
• SACH (1D10) (P)
• Variflex (P)
1 dayLevel walking
Walking along 10 m-walkway at SS speed
Biomechanical
• GRF
• COM mechanical work
• Work at push-off
• COP
• Step length
• Symmetry
Performance
• Speed
• Positive mechanical work COM performed by the trailing prosthetic limb was ↑ (33%, p = 0.01) and the negative work performed by the leading intact limb ↓ (13%, p = 0.04) with Variflex ↔ SACH foot
• ↓ step-to-step transition cost & ↑ mechanical push-off power and extended forward progression of the COP with Variflex ↔ SACH
Yang et al. 201710 TTA
• Age: 63.8 ± 2.5 yr
• Gender: M = 10, F = 0
• Weight: –
• TSA: 3.1 ± 0.8 yr
• MFCL: K2–K3
• AB-control group: Y/N
• Cause of amputation: –
Passive vs passive
• 1C30 Trias (P)
• 1C60 Triton (P)
1 weekLevel walking
Walking along 10 m-walkway at SS speed
Biomechanical
• Cadence
• Step width
• Step length
• Stance and swing phase ratio
• LE joint angles
• Ankle plantarflexion moment at end of stance
Performance
• Speed
• Cadence asymmetry with Trias was observed. Ankle plantarflexion at the end of stance and ankle supination at the onset of pre-swing ↓ with both prosthetic feet ↔ intact side. Other spatiotemporal, kinematic, and kinetic data showed no sign differences in a side-to-side comparison
• In a comparison between the two prosthetics, stance and swing ratio and ankle dorsiflexion through mid-stance was closer to normal with Triton ↔ Trias. Other spatiotemporal, kinematic, and kinetic data showed no statistically sign differences between prosthetics
Osseointegration
An osseointegrated prosthesis offers many advantages to individuals with an arm or leg amputation compared with a socket prosthesis (which fits over the stump of the amputated leg or arm). The attachment of the osseointegrated prosthesis is much more stable and provides a full range of joint movement, making walking much easier. An osseointegrated prosthesis does not cause pain or skin breakdown when used. Because the prosthesis is directly attached to the bone, the wearer feels as though their prosthesis is part of their own body by a process known as “natural osseoperception” (i.e. it feels as though it is their own leg or arm). Since 2009, the Radboud University Medical Centre (Radboudumc) in Nijmegen, the Netherlands, has been offering this highly innovative technique which significantly improves the quality of life of individuals with an amputation.In 2011, the Radboudumc carried out a study of the first 22 patients to be given an osseointegrated prosthesis at their centre. Aspects of walking and quality of life with the osseointegrated prosthesis were compared with a socket prosthesis. It was found that prosthesis use increased from 56 to 101 hours per week, walking speed increased by 32% and walking required 18% less energy with the osseointegrated prosthesis. Prosthesis-related quality of life improved from 39 to 62 on a scale of 0 to 100.Osseointegration is a safe treatment, and inflammation of the bone is rare. A disadvantage is that the area where the implant enters the skin (called the “stoma”) has to be cleaned twice daily with soap and water. This is comparable with brushing the teeth. In some cases, the skin around the stoma may become irritated. In the first year after implantation, intense muscle pain may be felt. This muscle pain disappears as soon as the stump muscles become fitter and stronger.
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