KinetiGait- Analysis of Depth Camera to Assist Gait Analysis for Unilateral Transtibial/Transfemoral Amputees

NCT ID: NCT04431817

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-03-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Lower Limb Amputation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Left transtibial

Left below knee amputation- 25

KinetiGait

Intervention Type DEVICE

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.

Right transtibial

Right below knee amputation- 25

KinetiGait

Intervention Type DEVICE

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.

Left transfemoral

Left above knee amputation- 25

KinetiGait

Intervention Type DEVICE

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.

Right transfemoral

Right above knee amputation- 25

KinetiGait

Intervention Type DEVICE

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.

Provider

Provider- 15

KinetiGait

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

KinetiGait

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* K0-K1 Medicare Functional Classification Levels
* Physically unstable or requires an ambulatory device
* Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Telemedicine & Advanced Technology Research Center

OTHER

Sponsor Role collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gabriel M Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

WRNMMC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37276273 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

189608

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.