21 Participants Needed

Exoskeleton for Balance After Stroke

JC
Overseen ByJesse C. Dean, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an exoskeleton designed to help stroke survivors improve walking balance. The researchers aim to determine if different exoskeleton settings, such as assistance or resistance levels, can make walking easier and safer. It is ideal for individuals who had a stroke at least six months ago, experience difficulty with their affected leg, and have had a fall or fear of falling in the past year. Participants should be able to walk on a treadmill without a cane or walker. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mobility solutions for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exoskeleton is safe for improving walking balance after stroke?

Research has shown that exoskeletons are generally safe for people recovering from strokes. One study on a high-resistance exoskeleton reported no negative effects, highlighting its safety. Another study on low-resistance exoskeletons found no significant negative effects during walking exercises.

For medium-resistance exoskeletons, research indicates they are strong and safe for helping stroke patients walk. Lastly, studies on exoskeletons with no resistance, which don't actively assist, have shown benefits in improving balance without safety concerns.

Overall, these findings suggest that exoskeletons, regardless of resistance level, are well-tolerated and safe for stroke rehabilitation.12345

Why are researchers excited about this trial?

Researchers are excited about the exoskeleton for balance after stroke because it offers a novel approach to rehabilitation. Unlike conventional physical therapy, which primarily relies on exercises and manual support, this exoskeleton uses adjustable impedance technology to assist walking. This means the exoskeleton can be fine-tuned to provide varying levels of support, from minimal to maximum, helping tailor the therapy to each patient's needs. By potentially improving balance and mobility more effectively than traditional methods, this technology could significantly enhance recovery outcomes for stroke survivors.

What evidence suggests that this exoskeleton is effective for improving balance after stroke?

Research has shown that exoskeletons can improve walking and balance in people who have had a stroke. These wearable devices aid in recovery and movement. For example, using an exoskeleton during rehabilitation has been linked to faster walking and better balance in stroke patients. In this trial, participants will experience different settings on the exoskeleton, such as high, medium, low, and zero impedance, to find the best method. While traditional rehabilitation remains effective, exoskeletons offer a promising new way to enhance walking and mobility.26789

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke and are experiencing difficulties with walking balance. Specific eligibility criteria to join the study or reasons for exclusion were not provided.

Inclusion Criteria

I am at least 21 years old.
I can walk at a speed of at least 0.2 meters per second.
I can follow instructions and communicate about my balance.
See 5 more

Exclusion Criteria

Presence of neglect
I have a history of serious heart conditions.
Resting blood pressure higher than 220/110 mm Hg
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will walk on a treadmill under several exoskeleton assistance conditions, including no exoskeleton, and varying impedance levels (zero, low, medium, high).

1 year
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Exoskeleton (high impedance)
  • Exoskeleton (low impedance)
  • Exoskeleton (medium impedance)
  • Exoskeleton (zero impedance)

Trial Overview

The study is testing different versions of an exoskeleton designed to help with walking balance after a stroke. Participants will be compared using no exoskeleton, or one set at low, zero, medium, or high impedance levels.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)Experimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials
83
Recruited
10,500+

Citations

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