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

NCT03980457 | Recruiting FDA Device

• 1 other identifier: 10742
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke; leg weakness; Exoskeleton

Outcome Measures

Primary Outcomes (2)

• The Functional Independence Measure (FIM™)

  It measure the degree of disability as well as the progress patients make throughout their medical rehabilitation programs. FIM Scale score varies from minimum of 18 to maximum of 126. Higher score better the outcome.

  Baseline (Day 1) and at 4-weeks to measure change

• The two minute walk test (2-MWT)

  It assess the walking distance over two minutes while moving at a comfortable speed. using any ambulation aids (such as cane, walkers, and rollators) used in everyday life. Normal walking speed is 360 ft.

  Baseline (Day 1) and at 4-weeks to measure change

Secondary Outcomes (3)

• Modified Ashworth Scale (MAS)

  Baseline (Day 1) and at 4-weeks to measure change

• Discharge disposition

  4-weeks

• The Beck Depression Inventory (BDI)

  Baseline (Day 1) and at 4-weeks to measure change

Study Arms (2)

Exo-group

EXPERIMENTAL

Standard rehabilitation plus use of Exoskeleton

Device: Indego Exoskeleton; Other: Standard Rehabilitation

Control-Group

PLACEBO COMPARATOR

Standard rehabilitation

Other: Standard Rehabilitation

Interventions

Indego Exoskeleton DEVICE

Powered generated orthosis

Exo-group

Standard Rehabilitation OTHER

Standard Rehabilitation

Control-Group; Exo-group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Aphasic patients unable to communicate
• Confused patients
• Patients medically unstable
• Patients unable to stand alone
• Refusal to provide written informed consent

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Oklahoma City VA Health Care System

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Meheroz H Rabadi, MD, MRCPI

  Affiliate; Oklahoma VA Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meheroz H Rabadi, MD, MRCPI

CONTACT

405-456-5298; rabadimh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label pragmatic study

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: June 10, 2019
• Study Start: September 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)