Lower Extremity ProblemNCT03625921
Transfemoral Powered Foot and Physical Therapy Study
A study testing Powered device with physical therapy and Powered device with standard of practice in people with Lower Extremity Problem and Prosthesis User, run by VA New York Harbor Healthcare System at 1 site in United States.
Trial summary
Individuals living with Transfemoral Amputation, enrolled equally at the Veterans Affairs New York Harbor Healthcare System (VANYHHS) and Walter Reed National Military Medical Center (WRNMMC), will be fit with a powered ankle-foot prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Problem, Prosthesis User
- What is being tested?
- Powered device with physical therapy and Powered device with standard of practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 14 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral TFA, any etiology
- Experienced (> 6 months) microprocessor knee user
- Less than or equal to 8 amputation related physical therapy sessions in the previous 6 months
- At least 18 y.o.
- High K2 or above ambulator
- Able to walk a minimum of 30 m without an assistive device
- Able to walk on treadmill for 5 minutes at self-selected speed with or without use of handrails
Who cannot join
- Inability to tolerate wearing of a socket or a poorly fitting socket
- Condition of intact limb prohibits prosthesis use (ulcers, sores, skin breakdown, burns, poor skin coverage, contractures, and severe heterotopic ossification)
- The length of the residual limb prohibits socket/device fitting
- Cognitive deficits or a mental health pathology limiting the ability to participate fully in the study or any deficit deemed by the PI to be detrimental to the completion of the study
- Significant comorbidity, which would interfere with the study (for example: neuropathy, uncontrolled diabetes, receiving dialysis, have insensate feet or severe phantom pain or a history of skin ulcers)
- Severe circulatory problems including peripheral vascular disease and pitting edema
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- Pregnant women in the 2nd trimester or beyond or women who will be in the 2nd trimester within the enrollment period. This will be determined by asking the participant if she is pregnant or if they believe they may be pregnant. The question will only be asked at inclusion, as biomechanical changes will only be impacted if the woman is in the 2nd or 3rd trimester, and will not be impacted if the participant becomes pregnant while in the study.
- Weigh more than 287 pounds at screening
- Use of non-prescribed opioids or over-use of any prescription drugs
- Major upper limb amputation
- Currently uses a powered ankle-foot prosthesis as a primary prosthesis or used a powered ankle-foot device as a primary prosthesis in the previous 6 months
- Any cardio-pulmonary, metabolic or integumentary diagnosis where walking for 15 minutes is contraindicated
Trial locations and contacts
1 site in 1 country.
United States1 site
VA New York Harbor Healthcare System
New York, New York, 10010
About this study
Official title: Effects of a Powered Ankle-Foot Prosthesis and Device-Specific Physical Therapy on Function and Pain for Individuals Living With Transfemoral Limb Loss
Individuals living with Transfemoral Amputation, enrolled equally at the Veterans Affairs New York Harbor Healthcare System (VANYHHS) and Walter Reed National Military Medical Center (WRNMMC), will be fit with a powered ankle-foot prosthesis. All subjects will undergo a full gait analysis, functional measures, neurocognitive/cognitive, and pain assessment at baseline utilizing their current passive prosthesis. Subjects will then be randomly assigned into 2 equal groups: Powered device with an 8-session intensive, device-specific PT intervention (Group A); or powered device with current standard of practice (Group B), with includes basic device education, but no PT intervention. Subjects in Group A will undergo a 4-week PT-based intervention, which will isolate the contribution of device specific effects from rehabilitation effects. Group B will receive the current standard of practice, which does not include any formal rehabilitation. All users will undergo a full gait analysis, functional measures, neurocognitive/cognitive, and pain assessment after 4- and 8-weeks of use.
- Conditions
- Lower Extremity Problem, Prosthesis User
- Being tested
- Powered device with physical therapy, Powered device with standard of practice
- Keywords
- Physical Therapy, Powered Prosthesis, Biomechanical outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered device with physical therapyBehavioural
Subjects will be fit with a powered prosthesis (Ottobock emPOWER) and enrolled in a device-specific physical therapy (PT) program.
Powered device with standard of practiceBehavioural
Subjects will be fit with a powered prosthesis (Ottobock emPOWER) and enrolled in the current standard of practice training, which includes basic device education and prosthetic training.
| Study group | Role | What they receive |
|---|---|---|
| Powered device with physical therapy | Experimental | Subjects will be fitted with a powered ankle-foot prosthesis (Ottobock emPOWER) and provided an intensive device-specific physical therapy (PT) intervention. The subjects will complete, on average, 8 PT training sessions lasting 30 - 45 minutes each. The subjects will also be provided with a home exercise program. Receives: Behavioral: Powered device with physical therapy |
| Powered device with standard of practice | Active comparator | Subjects will be fitted with a powered ankle-foot prosthesis (Ottobock emPOWER) and provided the current standard of practice training for use of this powered prosthesis. The prosthetist will confirm a stable and comfortable alignment and educate the subject on proper home usage. Next, the subject will undergo a 45 - 60 minute training with a physical therapist that is characteristic of the current standard of practice. Receives: Behavioral: Powered device with standard of practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Evaluation between PT and non-PT groups
Biomechanical evaluation of gait with 3D motion capture while the individual is walking at several different speeds.
Measured: Baseline, Week 4, and Week 8
Change in 6 minute walk test between PT and non-PT groups
The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.
Measured: Baseline, Week 4, and Week 8
Change in AmpPro between PT and non-PT groups
The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation.
Measured: Baseline, Week 4, and Week 8
Change in the CHAMP between PT and non-PT groups
The Comprehensive High-Level Activity Mobility Predictor (CHAMP) is a 4-item, more advanced instrument to measure prosthetic mobility for individuals in this study that scored > 38 on the AmpPro
Measured: Baseline, Week 4, and Week 8
Change from Baseline in Serial Subtraction at Week 4 and Week 8
Serial Subtraction is a cognitive test where participants are given a random 3 digit number and are asked to subtract by 3s while they walk for 1 minute on a treadmill at a comfortable walking speed. Total number of errors will be documented. Serial subtraction will be performed at baseline using their current prosthetic foot and again at 4- and 8-weeks utilizing the powered prosthesis.
Measured: Baseline, Week 4, and Week 8
Change from Baseline in COWAT at Week 4 and Week 8
The Controlled Oral Word Association Test (COWAT) is a cognitive test where participants are asked to list as many words as they can think of beginning with a certain letter while walking for 1 minute on a treadmill at a comfortable speed. The participants will complete 3 rounds (3 letters). The total number of unique words for each letter will be documented. COWAT will be performed at baseline using their current prosthetic foot and again at 4- and 8- weeks utilizing the powered prosthesis.
Measured: Baseline, Week 4, and Week 8
Change from Baseline in Category Test at Week 4 and Week 8
The Category Test is a cognitive test where participants are asked to list as many words as they can think of belonging to a certain category while walking for 1 minute on a treadmill at a comfortable speed. The total number of unique words for the category will be documented. The category test will be performed at baseline using their current prosthetic foot and again at 4- and 8- weeks utilizing the powered prosthesis.
Measured: Baseline, Week 4, and Week 8
Change from Baseline in CNS Vital Signs at Week 8
The CNS Vital Signs is a computerized neurocognitive assessment that assess 5 domains: memory, psychomotor speed, reaction time, complex attention, and cognitive flexibility. Participants will complete the online platform independently.
Measured: Baseline and Week 8
Secondary outcomes (4)
Change in Prosthetic Evaluation Questionnaire (PEQ) scores between PT and non-PT groups
The PEQ is a self-report Visual Analog Scale questionnaire for persons with lower limb amputations who use a prosthesis. It consists of 9 validated subscales. They are used to evaluate the prosthesis and life with the prosthesis. Most questions in the PEQ use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line to the point at which the respondent's mark crosses the line. Each line is 100 mm long and is always measured from the left (0-100). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response. Subscale scores are calculated by computing the average (arithmetic mean) of all the questions which make up that particular scale. Only subscales are calculated. A total combined score is not calculated.
Measured: Baseline, Week 4, and Week 8
Change in Promis Pain Interference levels between PT and non-PT groups
The Promis Pain Interference Scale is an 8-item self-report measure of pain interference over the last 7 days. There are 5 potential answers ranging from "not at all" to "very much" for participants to check off. Participants are only allowed to check off one answer per question.
Measured: Baseline, Week 4, and Week 8
Change in Quality of Life scores between PT and non-PT groups
The Quality of Life Scale is a single item visual analog scale used to measure the participants' quality of life over the past four weeks or since their last visit. The visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line to the point at which the respondent's mark crosses the line. The line is 100 mm long and is always measured from the left (0-100). On the left side of the scale (0 mm) it says "worst possible quality of life". On the right side of the scale (100 mm) it says "ideal quality of life, so the higher the score the more positive the response.
Measured: Baseline, Week 4, and Week 8
Change in Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) 4 Week responses between PT and non-PT groups
The PEQ-A 4 Weeks is a free response 2-item questionnaire in which the participant is asked about any falls and/or stumbles over the last four weeks or since his or her last visit.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start17 Nov 2017
- Primary completion14 Jan 2025
- Study completion14 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA New York Harbor Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed National Military Medical Center
- Responsible party
- Principal investigator, Jason Maikos, VA New York Harbor Healthcare System
- Investigators
- Jason Maikos, PhD, Principal investigator, Director, VISN 2 Gait and Motion Analysis Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625921
- Sponsor's protocol ID
- IRB #01643
- Other IDs
- CDMRP-OP160073
- Status last verified
- Apr 2025
- First submitted
- 5 Jun 2018
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maikos JT, Pruziner AL, Hendershot BD, Herlihy DV, Chomack JM, Hyre MJ, Phillips SL, Sidiropoulos AN, Dearth CL, Nelson LM. Effects of a Powered Ankle-Foot Prosthesis and Physical Therapy on Function for Individuals With Transfemoral Limb Loss: Rationale, Design, and Protocol for a Multisite Clinical Trial. JMIR Res Protoc. 2024 Jan 26;13:e53412. doi: 10.2196/53412.
PubMed 38277197
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Powered Ankle-Foot Prosthesis and Device-Specific Physical Therapy on Function and Pain for Individuals Living With Transfemoral Limb Loss
- ClinicalTrials.gov ID
- NCT03625921
- Acronym / sponsor ID
- IRB #01643
- Conditions
- Lower Extremity Problem, Prosthesis User
- Keywords
- Physical Therapy, Powered Prosthesis, Biomechanical outcomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA New York Harbor Healthcare SystemUS federal agency
- Collaborators
- Walter Reed National Military Medical Center
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 14 Jan 2025 (actual)
- Study completion
- 14 Jan 2026 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals living with Transfemoral Amputation, enrolled equally at the Veterans Affairs New York Harbor Healthcare System (VANYHHS) and Walter Reed National Military Medical Center (WRNMMC), will be fit with a powered ankle-foot prosthesis. All subjects will undergo a full gait analysis, functional measures, neurocognitive/cognitive, and pain assessment at baseline utilizing their current passive prosthesis. Subjects will then be randomly assigned into 2 equal groups: Powered device with an 8-session intensive, device-specific PT intervention (Group A); or powered device with current standard of practice (Group B), with includes basic device education, but no PT intervention. Subjects in Group A will undergo a 4-week PT-based intervention, which will isolate the contribution of device specific effects from rehabilitation effects. Group B will receive the current standard of practice, which does not include any formal rehabilitation. All users will undergo a full gait analysis, functional measures, neurocognitive/cognitive, and pain assessment after 4- and 8-weeks of use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Powered device with physical therapy | Experimental | Behavioral: Powered device with physical therapySubjects will be fitted with a powered ankle-foot prosthesis (Ottobock emPOWER) and provided an intensive device-specific physical therapy (PT) intervention. The subjects will complete, on average, 8 PT training sessions lasting 30 - 45 minutes each. The subjects will also be provided with a home exercise program. |
| Powered device with standard of practice | Active comparator | Behavioral: Powered device with standard of practiceSubjects will be fitted with a powered ankle-foot prosthesis (Ottobock emPOWER) and provided the current standard of practice training for use of this powered prosthesis. The prosthetist will confirm a stable and comfortable alignment and educate the subject on proper home usage. Next, the subject will undergo a 45 - 60 minute training with a physical therapist that is characteristic of the current standard of practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unilateral TFA, any etiology
- Experienced (> 6 months) microprocessor knee user
- Less than or equal to 8 amputation related physical therapy sessions in the previous 6 months
- At least 18 y.o.
- High K2 or above ambulator
Key exclusion criteria (12 listed)
- Inability to tolerate wearing of a socket or a poorly fitting socket
- Condition of intact limb prohibits prosthesis use (ulcers, sores, skin breakdown, burns, poor skin coverage, contractures, and severe heterotopic ossification)
- The length of the residual limb prohibits socket/device fitting
- Cognitive deficits or a mental health pathology limiting the ability to participate fully in the study or any deficit deemed by the PI to be detrimental to the completion of the study
- Significant comorbidity, which would interfere with the study (for example: neuropathy, uncontrolled diabetes, receiving dialysis, have insensate feet or severe phantom pain or a history of skin ulcers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Powered device with physical therapySubjects will be fit with a powered prosthesis (Ottobock emPOWER) and enrolled in a device-specific physical therapy (PT) program. | Behavioural | Powered device with physical therapy |
| Powered device with standard of practiceSubjects will be fit with a powered prosthesis (Ottobock emPOWER) and enrolled in the current standard of practice training, which includes basic device education and prosthetic training. | Behavioural | Powered device with standard of practice |
Primary outcome
Change in Gait Evaluation between PT and non-PT groups
Time frame: Baseline, Week 4, and Week 8
Biomechanical evaluation of gait with 3D motion capture while the individual is walking at several different speeds.
Change in 6 minute walk test between PT and non-PT groups
Time frame: Baseline, Week 4, and Week 8
The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.
Change in AmpPro between PT and non-PT groups
Time frame: Baseline, Week 4, and Week 8
The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation.
Change in the CHAMP between PT and non-PT groups
Time frame: Baseline, Week 4, and Week 8
The Comprehensive High-Level Activity Mobility Predictor (CHAMP) is a 4-item, more advanced instrument to measure prosthetic mobility for individuals in this study that scored > 38 on the AmpPro
Change from Baseline in Serial Subtraction at Week 4 and Week 8
Time frame: Baseline, Week 4, and Week 8
Serial Subtraction is a cognitive test where participants are given a random 3 digit number and are asked to subtract by 3s while they walk for 1 minute on a treadmill at a comfortable walking speed. Total number of errors will be documented. Serial subtraction will be performed at baseline using their current prosthetic foot and again at 4- and 8-weeks utilizing the powered prosthesis.
Change from Baseline in COWAT at Week 4 and Week 8
Time frame: Baseline, Week 4, and Week 8
The Controlled Oral Word Association Test (COWAT) is a cognitive test where participants are asked to list as many words as they can think of beginning with a certain letter while walking for 1 minute on a treadmill at a comfortable speed. The participants will complete 3 rounds (3 letters). The total number of unique words for each letter will be documented. COWAT will be performed at baseline using their current prosthetic foot and again at 4- and 8- weeks utilizing the powered prosthesis.
Change from Baseline in Category Test at Week 4 and Week 8
Time frame: Baseline, Week 4, and Week 8
The Category Test is a cognitive test where participants are asked to list as many words as they can think of belonging to a certain category while walking for 1 minute on a treadmill at a comfortable speed. The total number of unique words for the category will be documented. The category test will be performed at baseline using their current prosthetic foot and again at 4- and 8- weeks utilizing the powered prosthesis.
Change from Baseline in CNS Vital Signs at Week 8
Time frame: Baseline and Week 8
The CNS Vital Signs is a computerized neurocognitive assessment that assess 5 domains: memory, psychomotor speed, reaction time, complex attention, and cognitive flexibility. Participants will complete the online platform independently.
4 secondary outcomes
Change in Prosthetic Evaluation Questionnaire (PEQ) scores between PT and non-PT groups
Time frame: Baseline, Week 4, and Week 8
Change in Promis Pain Interference levels between PT and non-PT groups
Time frame: Baseline, Week 4, and Week 8
Change in Quality of Life scores between PT and non-PT groups
Time frame: Baseline, Week 4, and Week 8
Change in Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) 4 Week responses between PT and non-PT groups
Time frame: Baseline, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 38277197Maikos JT, Pruziner AL, Hendershot BD, Herlihy DV, Chomack JM, Hyre MJ, Phillips SL, Sidiropoulos AN, Dearth CL, Nelson LM. Effects of a Powered Ankle-Foot Prosthesis and Physical Therapy on Function for Individuals With Transfemoral Limb Loss: Rationale, Design, and Protocol for a Multisite Clinical Trial. JMIR Res Protoc. 2024 Jan 26;13:e53412. doi: 10.2196/53412.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Maikos, PhD principal investigator
Director, VISN 2 Gait and Motion Analysis Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered device with physical therapy and Powered device with standard of practice in people with Lower Extremity Problem and Prosthesis User, run by VA New York Harbor Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait Evaluation between PT and non-PT groups (time frame: Baseline, Week 4, and Week 8). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03625921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.