Electric boost for balance: could a simple device help stroke survivors avoid falls?

NCT ID NCT06127602

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Recruiting now This study
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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.
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Paused for now. It may or may not start again.
Ongoing
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 Results may not be published yet.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)

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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.

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Status unknown
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First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study investigates whether adding neuromuscular electrical stimulation (NMES) to reactive balance training helps people who have had a stroke recover more effectively from slips and trips. Participants, who are at least six months post-stroke and able to walk on a treadmill, will undergo six weeks of training with either real or sham NMES. The goal is to see if the stimulation improves balance control and reduces fall risk.

What this could mean

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

Active substance
Neuromuscular electrical stimulation (NMES) applied to leg muscles during balance training
What this could lead to
If successful, this approach could lead to more effective fall-prevention therapies for people recovering from stroke.
What could go wrong
This is an early-phase study with only 46 participants, so results may not apply to all stroke survivors. The electrical stimulation may cause discomfort or skin irritation.

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 46 people

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

Started

Mar 2024

Expected to finish

May 2027

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 90 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: * Age group: 18-90 years. * Presence of hemiparesis. * Onset of stroke (\> 6 months). * Ability to walk at least for 2 minutes on the treadmill with or without ankle foot orthosis. * Can understand and communicate in English. * Cognitively and behaviorally capable of complying with the regimen (Mini-Mental State Examination \> 25/30). * No history or recent use (i.e., past 6 weeks) of any Neuromuscular electrical stimulation device to leg muscles during walking (e.g., Bioness, Walkaide). Exclusion Criteria: * Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during rest, or 3) oxygen saturation (measured by pulse oximeter) \< 95% during rest. * Body weight of more than 250 lbs. * Spasticity (Ashworth scale \> 2). * Loss of protective sensations on the paretic leg (indicated by inability to perceive the 5.07/10 g on Semmes-Weinstein Monofilament) or inability to feel the NMES. * Severe osteoporosis (indicated by T score \< -2) * Cognitive impairment (indicated by Mini-Mental State Exam score\<25) * Global Aphasia (indicated by \<71% on the Mississippi Aphasia Screening Test). * Subjects with Chedoke McMaster Leg Assessment Scale score (\> 4).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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Contacts and locations

Locations

  • University of Illinois at Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

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