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Can a treadmill plus brain games help stroke patients walk again?

NCT ID NCT04625127

Symptom relief Sponsor: Spaulding Rehabilitation Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study tests a device called GaitBetter that combines treadmill walking with cognitive training (like thinking tasks) to help stroke survivors improve their walking and balance. About 76 people who had a stroke (either within 8 weeks or more than 6 months ago) will use the device for 15 sessions over 5 weeks. The goal is to see if it helps them walk faster, think better, and lower their risk of falling.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GaitBetter device (treadmill gait training with cognitive tasks)
What this could lead to
If successful, this could offer a new rehab tool to help stroke survivors walk better and reduce fall risk.
What could go wrong
This is a small, early-stage study (76 participants) testing usability and efficacy, so results may not apply broadly. The device is not yet proven to be better than standard therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and females of age between 18 to 85 year of age * History of one-sided ischemic or hemorrhagic stroke * Chronic: more than 6 months post-stroke (Aim 1 and Aim 2) * Subacute: within 8 weeks post-stroke (Aim 1 and Aim 3) * Residual functional impairment of a lower extremity as a result of the stroke * Ability to walk at least 15 meters with or without assistive devices (FIM walk subsection, levels 6 and 7) * Ability to walk 3 consecutive minutes (5 minutes for Aim 2) on a treadmill at a speed equal to or greater than 0.22 m/s (0.8 km/h or 0.5 mph) with or without hand support. * Medical clearance received from treating physician to participate in the gait training program proposed in the study Exclusion Criteria: * Severe aphasia limiting the ability to express needs or discomfort verbally or non-verbally * Cognitive impairment limiting the ability to understand and follow instructions (as assessed by a score \<23 on the Mini Mental State Examination) * Previous diagnosis of neurological diseases other than stroke * Recent history of lower extremity fractures (\<12 months ago), unhealed wounds * Current indication for isolation precautions (e.g. MRSA, VRE, C. difficile, and others) * Severe visual impairments (as assessed by the NIH Stroke Scale Visual Field subscale. score \>0) * Hemispatial neglect (as assessed by the Line Bisection Test) * Subjects diagnosed with a medical condition that would interfere with their participation in regular sustained exercise (such as a severe pulmonary and/or cardiovascular condition) * For Aim 2: currently participating in a gait training intervention (PT or research) * Adults with impaired decision-making capacity * Women who are pregnant

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Conditions

The condition(s) this trial relates to.

Gait Disorders, Neurologic hemiplegia stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gait, hemiplegic Hemiplegia Stroke

Contacts and locations

Locations

  • Spaulding Rehabilitation Hospital Boston

    Boston, Massachusetts, 02129, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.