Lower Limb AmputationNCT04431817
KinetiGait- Analysis of Depth Camera to Assist Gait Analysis for Unilateral Transtibial/Transfemoral Amputees
An observational study of Lower Limb Amputation, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
This is a feasibility study about implementing and using the KinetiGait gait analysis system in clinical practice to enhance the rehabilitation of service members with lower limb disfunction. There will be questionnaires completed by participants and surveys completed by both participant and provider. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- KinetiGait
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 28 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include individuals who are DEERS-eligible between the ages of 18 and 65 and in K2-K4 Medical Functional Classification levels. The providers must be MHS providers.
Who may be able to join
- Unilateral transfemoral or transtibial amputee
- Fitted by a prosthetist at a Military Treatment Facility
- K2-K4 Medicare Functional Classification Levels
- DEERS-eligible.
- For providers: MHS provider
Who cannot join
- K0-K1 Medicare Functional Classification Levels
- Physically unstable or requires an ambulatory device
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Operational Analysis of Depth Camera to Assist Gait Analysis in Outpatient Rehabilitation for Unilateral Transtibial and Transfemoral Amputees
This is a feasibility study about implementing and using the KinetiGait gait analysis system in clinical practice to enhance the rehabilitation of service members with lower limb disfunction. There will be questionnaires completed by participants and surveys completed by both participant and provider.
Read the detailed description
We propose a feasibility study about implementing and using the KinetiGait gait analysis system in clinical practice to enhance the rehabilitation of service members with lower limb dysfunction. Up to 100 subjects will be consented, with the expectation that 80% (e.g., n=80) will complete the study with a complete dataset. Baseline sessions will consist of 7 minutes of walking at a self-selected speed between 0.7 and 1.3 m/s, after which participants will take the PLUS-M 12 Item Short Form and PROMIS-29 questionnaires, as well as a short survey. Participants will complete the questionnaires again at 1 month and 3 month. Providers who observed/operated the KinetiGait system will also take a short survey on ease of use and satisfaction.
- Conditions
- Lower Limb Amputation
- Being tested
- KinetiGait
- Keywords
- depth camera, gait analysis, LE loss, SMs and Veterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinetiGaitDevice
This device is an Intel RGB depth camera that relays video to gait analysis software. The images will be taken from amputees walking at a self-selected pace on a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Left transtibial | Left below knee amputation- 25 Receives: Device: KinetiGait | |
| Right transtibial | Right below knee amputation- 25 Receives: Device: KinetiGait | |
| Left transfemoral | Left above knee amputation- 25 Receives: Device: KinetiGait | |
| Right transfemoral | Right above knee amputation- 25 Receives: Device: KinetiGait | |
| Provider | Provider- 15 Receives: Device: KinetiGait |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic Limb Users Survey of Mobility (PLUS-M)
12-item short form to assess functional status, quality of life and perceived mobility.
Measured: 5-10 minutes
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Measures self-reported capability rather than actual performance of physical capabilities.
Measured: 5-10 minutes
Secondary outcomes (1)
Provider survey
Survey for providers indicating age, level of clinical training, experience with gait analysis and views on integrating technology into the clinical environment.
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Aug 2021
- Primary completion14 Mar 2023
- Study completion28 Mar 2023
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 Limb AmputationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Telemedicine & Advanced Technology Research Center
- Responsible party
- Sponsor
- Investigators
- Gabriel M Kim, M.D., Principal investigator, WRNMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431817
- Sponsor's protocol ID
- 189608
- Status last verified
- Jul 2025
- First submitted
- 11 Jun 2020
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
PubMed 37276273
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operational Analysis of Depth Camera to Assist Gait Analysis in Outpatient Rehabilitation for Unilateral Transtibial and Transfemoral Amputees
- ClinicalTrials.gov ID
- NCT04431817
- Acronym / sponsor ID
- 189608
- Conditions
- Lower Limb Amputation
- Keywords
- depth camera, gait analysis, LE loss, SMs and Veterans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Telemedicine & Advanced Technology Research Center
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 16 Jun 2020 (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.
This is a feasibility study about implementing and using the KinetiGait gait analysis system in clinical practice to enhance the rehabilitation of service members with lower limb disfunction. There will be questionnaires completed by participants and surveys completed by both participant and provider.
Detailed description
We propose a feasibility study about implementing and using the KinetiGait gait analysis system in clinical practice to enhance the rehabilitation of service members with lower limb dysfunction. Up to 100 subjects will be consented, with the expectation that 80% (e.g., n=80) will complete the study with a complete dataset. Baseline sessions will consist of 7 minutes of walking at a self-selected speed between 0.7 and 1.3 m/s, after which participants will take the PLUS-M 12 Item Short Form and PROMIS-29 questionnaires, as well as a short survey. Participants will complete the questionnaires again at 1 month and 3 month. Providers who observed/operated the KinetiGait system will also take a short survey on ease of use and satisfaction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Left transtibial | – | Device: KinetiGaitLeft below knee amputation- 25 |
| Right transtibial | – | Device: KinetiGaitRight below knee amputation- 25 |
| Left transfemoral | – | Device: KinetiGaitLeft above knee amputation- 25 |
| Right transfemoral | – | Device: KinetiGaitRight above knee amputation- 25 |
| Provider | – | Device: KinetiGaitProvider- 15 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include individuals who are DEERS-eligible between the ages of 18 and 65 and in K2-K4 Medical Functional Classification levels. The providers must be MHS providers.
Key inclusion criteria (5 listed)
- Unilateral transfemoral or transtibial amputee
- Fitted by a prosthetist at a Military Treatment Facility
- K2-K4 Medicare Functional Classification Levels
- DEERS-eligible.
- For providers: MHS provider
Key exclusion criteria (3 listed)
- K0-K1 Medicare Functional Classification Levels
- Physically unstable or requires an ambulatory device
- Pregnant women
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 |
|---|---|---|
| KinetiGaitThis device is an Intel RGB depth camera that relays video to gait analysis software. The images will be taken from amputees walking at a self-selected pace on a treadmill. | Device | Left transfemoral, Left transtibial, Provider, Right transfemoral, Right transtibial |
Primary outcome
Prosthetic Limb Users Survey of Mobility (PLUS-M)
Time frame: 5-10 minutes
12-item short form to assess functional status, quality of life and perceived mobility.
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Time frame: 5-10 minutes
Measures self-reported capability rather than actual performance of physical capabilities.
1 secondary outcome
Provider survey
Time frame: 5-10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Derived from this study: PubMed 37276273B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
- Individual participant dataSharing planned: No
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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.
Gabriel M Kim, M.D. principal investigator
WRNMMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Amputation, run by Henry M. Jackson Foundation for the Advancement of Military Medicine 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prosthetic Limb Users Survey of Mobility (PLUS-M) (time frame: 5-10 minutes). The study lists 2 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 NCT04431817, 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 20 Jul 2025.