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Behavioural Intervention

Walking Balance Training for Stroke

N/A

Recruiting

Led By Keith Gordon, PhD

Research Sponsored by Northwestern University Feinberg School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to ambulate over ground for 10 meters with or without a single cane, and/or ankle-foot orthosis

18 to 80 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for aim 1, step length will be performed at session 1 and after a week on session 2. for aim 2, step length will be calculated at session 1 and after 5 weeks of training at session 12. each of these sessions will be two hours long.

Awards & highlights

Study Summary

This trial aims to find out if a robotic device can improve walking balance of people with chronic stroke, which could improve their quality of life and ability to participate in walking activities.

Who is the study for?

This trial is for adults aged 18-80 who had a stroke at least 6 months ago and can walk 10 meters with or without help. It's not for pregnant individuals, those with significant cognitive issues, severe speech impairments, extreme muscle stiffness in the legs, inability to stand for short periods, or if they have other serious health conditions affecting walking.Check my eligibility

What is being tested?

The study tests a new way of improving walking balance using high-intensity gait training with a robotic device that amplifies movements. This method could potentially enhance mobility and quality of life for people who've had strokes.See study design

What are the potential side effects?

While specific side effects are not detailed here, participants may experience fatigue or discomfort from the physical nature of the training. The use of robotics might also pose risks like minor injuries due to amplified movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk 10 meters with or without help from a cane or ankle support.

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I am between 18 and 80 years old.

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I have been diagnosed with a stroke that affects one side of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for aim 1, margin of stability will be calculated at session 1 and after a week on session 2. for aim 2, margin of stability will be calculated at session 1 and after 5 weeks of training at session 12. each of these sessions will be two hours long.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for aim 1, margin of stability will be calculated at session 1 and after a week on session 2. for aim 2, margin of stability will be calculated at session 1 and after 5 weeks of training at session 12. each of these sessions will be two hours long.

This trial's timeline: 3 weeks for screening, Varies for treatment, and for aim 1, margin of stability will be calculated at session 1 and after a week on session 2. for aim 2, margin of stability will be calculated at session 1 and after 5 weeks of training at session 12. each of these sessions will be two hours long. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

10 Meter Walk Test (10MWT)

6 minute walk test (6WMT)

Activities-specific Balance Confidence (ABC) Scale

+6 more

Secondary outcome measures

Blood pressure

Chedoke-McMaster Stroke Assessment (CMSA) scale

Exertion

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Control of lateral COM motion during and after walking practiced in the MAEExperimental Treatment1 Intervention

For Aim 1a, participant's preferred and fast treadmill walking speeds will be determined followed by 2-min of baseline walking. Each participant will perform eight 2-min trials of treadmill walking 1) Null Environment: no forces, 2) MAE Low Gain: 25 Nsm-1, 3) MAE Medium Gain: 35 Nsm-1, 4) MAE High Gain: 45 Nsm-1, that will be repeated at both treadmill walking speeds. The trial order will be randomized. For Aim 1b, we will assess participant's maximum ability to control their lateral COM motion with no forces applied, using three 21-meter walking trials with visual projections on the treadmill to provide feedback used to challenge their lateral COM motion control. Five 2-min trials in a Null environment will be followed by COM control assessment. Participants will rest and repeat the above sequence in a MAE. The order of the external environments will be randomized across participants. Participants may participate in more than one aim (1a, 1b and 2).

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Northwestern University Feinberg School of MedicineLead Sponsor

38 Previous Clinical Trials

14,841 Total Patients Enrolled

Keith Gordon, PhDPrincipal InvestigatorAssistant Professor, Northwestern University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to enroll in this trial?

"Yes, the data hosted on clinicaltrials.gov verifies that this medical experiment is actively enrolling patients at present. The trial was initially advertised on August 1st 2023 and has been edited most recently on October 17th 2023. 30 participants are needed from a single location to complete the study."

Answered by AI

What is the aggregate number of participants involved in this experiment?

"Yes, clinicaltrials.gov affirms that this medical experiment is actively looking for 30 participants from 1 recruitment site. The study was first posted on August 1st 2023 and has since been amended as of October 17th 2023."

Answered by AI

What are the main goals of this clinical exploration?

"The primary end goal of this trial is to establish the minimal lateral margin of stability. Secondary aims involve evaluating step width, measuring participant's vital signs as a measure for their cardiovascular response, and assessing exertion via a 6-20 point scale rating system. Each session will span two hours with COM excursion calculated at the start and conclusion of each session during Aim 1, while in Aim 2 it will be measured pre-trial then again after 5 weeks of training has taken place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Walking Balance Training Post-Stroke

2023. "Walking Balance Training Post-Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06090604.