MedTrace Logo

Mobility Training Using Exoskeletons for Functional Recovery After Stroke

NCT02128152 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-01

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and effectiveness of the Ekso robotic exoskeleton in persons affected by a severe stroke.

* Primary Objectives:

* To determine if a structured high-dosage exoskeleton training program (EXTP) results in clinically significant gains in walking recovery in individuals affected by severe stroke.
* To determine whether timing of EXTP delivery (i.e., sub-acute vs. chronic) and severity (non-ambulators vs. limited house-hold ambulators) affects the improvement in gait speed and overall function following the EXTP training protocol.
* To determine whether maintenance or further improvement in gait speed can be achieved by an intensive follow-up program of either a traditional rehabilitation program (TRP) or extended EXTP.
* Secondary Objectives:

* To determine the effect on functional walking endurance as assessed by the 6 minute walk test and 10 meter walk test, in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting for post stroke individuals.
* To determine the effect on functional balance, as assessed by the Berg Balance Scale, Functional Gait Assessment and Five times sit to stand measure as assessed by the 6 minute walk test, in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting for post stroke individuals.
* To determine the effect on stroke recovery, as assessed by the step counter of task specific training in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting

Conditions

  • Severe Stroke or Similar Neurological Muscle Weakness

Interventions

DEVICE

Ekso exoskeleton

Sponsors & Collaborators

  • U.S. Department of Education

    collaborator FED

  • Shirley Ryan AbilityLab

    lead OTHER

Principal Investigators

  • Arun Jayaraman, PT, PhD · Shirley Ryan AbilityLab

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02128152 on ClinicalTrials.gov