Recruiting

Exoskeleton-Assisted Gait Training

Sponsor:

University of Oklahoma

Code:

NCT03980457

Conditions

Stroke

Weakness of Extremities as Sequela of Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Indego Exoskeleton

Standard Rehabilitation

Study Details

Brief summary:

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.

Conditions

Stroke

Weakness of Extremities as Sequela of Stroke

Study ID

NCT03980457

Start date

Sep 1, 2021

Status verified date

Mar, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. All patients with acute hemorrhagic or ischemic stroke documented clinically and by neuroimaging.
2. Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
3. Depressed patients will be included in the study
4. Patients able to stand alone
5. Patients able to provide a written informed consent, from cognitively intact patients (admission Mini Mental Scale Examination \[MMSE\] greater than or equal to 21).

Exclusion Criteria:

1. Aphasic patients unable to communicate
2. Confused patients
3. Patients medically unstable
4. Patients unable to stand alone
5. Refusal to provide written informed consent

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exo-group

Standard rehabilitation plus use of Exoskeleton

placebo comparator: Control-Group

Standard rehabilitation

Interventions

Indego Exoskeleton

Powered generated orthosis

Standard Rehabilitation

Standard Rehabilitation

Primary outcome measure

  • The Functional Independence Measure (FIM™) [ Time Frame: Baseline (Day 1) and at 4-weeks to measure change ]
  • The two minute walk test (2-MWT) [ Time Frame: Baseline (Day 1) and at 4-weeks to measure change ]

Central Contacts and Locations

Central contacts

Meheroz H Rabadi, MD, MRCPI

405-456-5298rabadimh@gmail.com

Locations

Oklahoma City VA Health Care System

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Meheroz Rabadi, MD, MRCPI

405-456-5298meheroz.rabadi@va.gov

Principal Investigator:

Meheroz Rabadi, MD, MRCPI

More Information

Sponsor

University of Oklahoma

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • Stroke
  • leg weakness
  • Exoskeleton

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-04-01.