Powered Orthotic Exoskeleton Training in Stroke

Part of paid clinical trials in The Bronx, New York.

Sponsor
VA Office of Research and Development
Study ID
NCT04241848
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Keeogo — DEVICE
    A new and novel type of robotic-device (Keeogo, B-temia, Inc.) was developed to provide powered assistance at the knee for persons with stroke. This device provides assistance for both knee extension and knee flexion during ambulation, transfers to standing and sitting, in addition to ascending and descending stairs. As this device isn't able to fully control the movement, it requires the ability of the patient to stand and initiate stepping. The approach the Keeogo uses to monitor the desired movement in order to appropriately provide assistance. This promotes intuitive learning for the user, minimizing the amount of instruction and practice needed to effectively ambulate allowing users to independently ambulate within one session. This device does not restrict leg movement, so the user can side-step and walk backwards. However, it does not provide assistance during these movements.
  • Ambulation training — OTHER
    Ambulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety.

Study Details

Veterans who suffer strokes often have disturbances in the ability to walk that reduces independence and quality of life. Alterations in gait combined with general decreased activity are associated with reduced muscle strength of the paretic leg. This leads to cardiovascular deconditioning and reduced quality of life. There is a new and novel battery powered device (Keeogo powered orthotic exoskeleton) that uses motors that assist knee movement while walking, sitting down, and standing up. The Keeogo monitors hip movement to assist the knee, making it simple to learn how to use. If successful, this project will show how this device will help improve the ability to walk and provide evidence to support larger clinical trials in a home and community setting to improve mobility, increase muscle mass and strength in the legs, as well as improve general health and quality of life. Lastly, this device could be used to increase motivation and confidence in a person to walk for longer periods of time and distance, providing the ability to walk in places that were previously inaccessible.

Key Dates

Start date
Nov 2, 2020
Status verified
May 2025
Primary completion
May 30, 2024
Completion
May 30, 2024

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Powered Orthotic Exoskeleton Training Group
    Participant in 36 session ambulation training using a powered orthotic exoskeleton.
  • Active Comparator: Control Group
    Participant in 36 session ambulation training without using a powered orthotic exoskeleton.

Primary Outcome Measure

Five Times Sit to Stand Test (5xSTS) [ Time Frame: Change from Baseline after completing 36 training sessions (approximately three months time) ]

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters VA Medical Center, Bronx, NYThe BronxNew York10468-3904-

Find similar trials in The Bronx, NY

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
James J. Peters VA Medical Center, Bronx, NY· The Bronx, NY

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