Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
Study Details
Study Description
Brief Summary
Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at the same speeds as non-amputees and this discrepancy is more apparent at faster walking speeds. Amputees choose to walk at speeds 30-40% slower than non-amputees. Preferred walking speed is likely influenced by elevated metabolic energy, but the underlying reason for slower preferred walking speeds is not fully understood. Unilateral amputees exhibit highly asymmetrical gait patterns that likely require more metabolic energy and impair functional mobility, increasing the risk of degenerative joint disease, osteo-arthritis and lower back pain. Improvements in prosthetic devices could enhance mobility in amputees, thus positively effecting rehabilitation and ambulation in veterans. A prosthesis that allows amputees to reduce metabolic energy would be especially useful for rehabilitation in older, ill individuals with reduced exercise capacities and could literally restore walking ability in people that are currently non-ambulatory.
Hypotheses. Amputees wearing the Massachusetts Institute of Technology (MIT) Powered Ankle-Foot (PAF) prosthesis will have a lower metabolic cost, faster preferred walking speed, and improved gait symmetry during walking than amputees wearing a conventional prosthesis and will have nearly the same metabolic cost, preferred walking speed, and gait symmetry during walking as age, gender, height, and weight matched non-amputees.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prosthesis Powered ankle-foot prosthesis and passive-elastic prosthesis |
Device: Powered ankle-foot prosthesis
The powered ankle-foot prosthesis is comprised of a series-elastic actuator (SEA) and an elastic leaf spring. This technology has been previously developed for robotic and human rehabilitation applications. The SEA allows for precise force control of the ankle joint, thus mimicking the spring-like behavior of the human ankle, as well as providing adequate energy for forward progression of the body. From the early stance period to the mid-stance period of walking, the SEA will be controlled so that the ankle joint behaves like a spring. During the late stance period, the SEA will be employed to power the forward movement of the body. The elastic leaf spring will provide shock absorption during foot strike, energy storage during early stance, and energy return during late stance.
|
| Experimental: Non-amputee Non-amputee |
Other: No device
|
Outcome Measures
Primary Outcome Measures
- Metabolic Cost of Transport [1 year]
We measured and compared gross rates of oxygen consumption and carbon dioxide production using a portable metabolic analysis system (Cosmed K4b2, IT) while participants walked at five constance velocities (0.75, 1.00, 1.25, 1.50 and 1.75 m/s) on a level treadmill (SoleFitness F85). We calculated average steady-state metabolic power in Watts (W) from 4-6 min of each trial using a standard equation. Then, we divided the metabolic power by each participant's weight and velocity to calculate the metabolic cost of transport (J/Nm).
Secondary Outcome Measures
- Preferred Walking Velocity [1 year]
We determined preferred walking velocity by incrementally increasing and decreasing treadmill velocity until each participant ascertained the velocity that they felt most comfortable.
- Trailing Leg Step-to-step Transition Work [1 year]
We calculated step-to-step transition work, the work done by each individual leg on the center of mass during transitions, using the individual limbs method described by Donelan et al. 2002. Trailing leg step-to-step transition work quantifies the amount of push-off work done by the trailing leg when both feet are on the ground during walking. Work (J) is normalized to each subject's mass (kg).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
20 healthy adult volunteers, 10 unilateral trans-tibial amputees and 10 matched non-amputees, will be recruited and screened
-
Amputees must be at least 1 year post-amputation, high-functioning (at least a K3 level of ambulation), and whose cause of amputation is either traumatic or vascular. Medicare defines a K3 level amputee as an ambulator who has the ability or potential for prosthetic ambulation with variable cadence, who has the ability to traverse most environmental barriers and who may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Medical Center, Providence | Providence | Rhode Island | United States | 02908 |
Sponsors and Collaborators
- US Department of Veterans Affairs
- Massachusetts Institute of Technology
Investigators
- Principal Investigator: Alena Grabowski, PhD BA, VA Eastern Colorado Health Care System, Denver, CO
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A6749-M
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Prosthesis | Non-amputees |
|---|---|---|
| Arm/Group Description | Subjects with transtibial amputation using a powered and passive ankle-foot prosthesis | Non-amputees |
| Period Title: Overall Study | ||
| STARTED | 8 | 8 |
| COMPLETED | 8 | 8 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Prosthesis | Non-amputee | Total |
|---|---|---|---|
| Arm/Group Description | Subjects with transtibial amputation using a passive ankle-foot prosthesis | Non-amputees | Total of all reporting groups |
| Overall Participants | 8 | 8 | 16 |
| Age (years) [Mean (Standard Deviation) ] | |||
| 18 - 65 years |
46
(8)
|
49
(9)
|
47.5
(8.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
8
100%
|
8
100%
|
16
100%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
8
100%
|
8
100%
|
16
100%
|
Outcome Measures
| Title | Metabolic Cost of Transport |
|---|---|
| Description | We measured and compared gross rates of oxygen consumption and carbon dioxide production using a portable metabolic analysis system (Cosmed K4b2, IT) while participants walked at five constance velocities (0.75, 1.00, 1.25, 1.50 and 1.75 m/s) on a level treadmill (SoleFitness F85). We calculated average steady-state metabolic power in Watts (W) from 4-6 min of each trial using a standard equation. Then, we divided the metabolic power by each participant's weight and velocity to calculate the metabolic cost of transport (J/Nm). |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Participants With an Amputation Using a Passive Prosthesis | Participants With an Amputation Using a Powered Prosthesis | Non-amputees |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 7 | 7 | 7 |
| 0.75 m/s |
4.76
(0.30)
|
4.57
(0.66)
|
4.68
(0.65)
|
| 1.00 m/s |
4.11
(0.37)
|
3.77
(0.31)
|
3.71
(0.42)
|
| 1.25 m/s |
3.95
(0.34)
|
3.57
(0.41)
|
3.41
(0.45)
|
| 1.50 m/s |
4.15
(0.18)
|
3.78
(0.34)
|
3.60
(0.39)
|
| 1.75 m/s |
4.59
(0.35)
|
4.09
(0.49)
|
3.69
(0.35)
|
| Title | Preferred Walking Velocity |
|---|---|
| Description | We determined preferred walking velocity by incrementally increasing and decreasing treadmill velocity until each participant ascertained the velocity that they felt most comfortable. |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Participants With an Amputation Using a Passive Prosthesis | Participants With an Amputation Using a Powered Prosthesis | Non-amputees |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 7 | 7 | 7 |
| Mean (Standard Deviation) [m/s] |
1.16
(0.17)
|
1.42
(0.15)
|
1.41
(0.25)
|
| Title | Trailing Leg Step-to-step Transition Work |
|---|---|
| Description | We calculated step-to-step transition work, the work done by each individual leg on the center of mass during transitions, using the individual limbs method described by Donelan et al. 2002. Trailing leg step-to-step transition work quantifies the amount of push-off work done by the trailing leg when both feet are on the ground during walking. Work (J) is normalized to each subject's mass (kg). |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Participants With an Amputation Using a Passive Prosthesis | Participants With an Amputation Using a Powered Prosthesis | Non-Amputees |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 7 | 7 | 7 |
| 0.75 m/s |
0.114
(0.011)
|
0.155
(0.016)
|
0.165
(0.012)
|
| 1.00 m/s |
0.125
(0.008)
|
0.194
(0.013)
|
0.179
(0.007)
|
| 1.25 m/s |
0.123
(0.006)
|
0.199
(0.013)
|
0.199
(0.010)
|
| 1.50 m/s |
0.131
(0.006)
|
0.239
(0.017)
|
0.240
(0.014)
|
| 1.75 m/s |
0.148
(0.014)
|
0.217
(0.016)
|
0.259
(0.012)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Prosthesis | Non-amputees | ||
| Arm/Group Description | Subjects with transtibial amputation using a powered and passive ankle-foot prosthesis | Non-amputees | ||
All Cause Mortality |
||||
| Prosthesis | Non-amputees | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Prosthesis | Non-amputees | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/8 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Prosthesis | Non-amputees | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/8 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Alena Grabowski |
|---|---|
| Organization | Eastern Colorado Healthcare System |
| Phone | 303-492-5208 |
| alena.grabowski@va.gov |
- A6749-M