Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT03980457
Status
Recruiting

Conditions

  • Stroke
  • Weakness of Extremities as Sequela of Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Indego Exoskeleton — DEVICE
    Powered generated orthosis
  • Standard Rehabilitation — OTHER
    Standard Rehabilitation

Study Details

The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.

Key Dates

Start date
Sep 1, 2021
Status verified
Mar 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exo-group
    Standard rehabilitation plus use of Exoskeleton
  • Placebo Comparator: Control-Group
    Standard rehabilitation

Primary Outcome Measure

The Functional Independence Measure (FIM™) [ Time Frame: Baseline (Day 1) and at 4-weeks to measure change ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oklahoma City VA Health Care SystemOklahoma CityOklahoma73104
Meheroz Rabadi, MD, MRCPI
405-456-5298
Meheroz Rabadi, MD, MRCPI (PRINCIPAL_INVESTIGATOR)

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