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Behavioural Intervention

NewGait for Stroke

N/A
Recruiting
Led By Chandramouli Krishnan, PT, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unilateral cortical or subcortical stroke
Able to walk independently with/without assistive devices for 5-10 mins (~150m)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
Awards & highlights

Study Summary

This trial aims to improve a walking assistance device for stroke survivors to use at home. They will modify the current design based on feedback from patients and clinicians. They will then test the device in a short

Who is the study for?
This trial is for stroke survivors who need help with walking. It's testing a new, affordable device called NewGait designed to improve gait at home. Participants should be able to walk at least a little bit and give feedback on the device.Check my eligibility
What is being tested?
The study compares the NewGait system, which aims to assist with walking post-stroke, against a standard control orthotic device. The goal is to see if NewGait offers better support and usability in improving gait.See study design
What are the potential side effects?
Since this trial involves physical rehabilitation devices, potential side effects may include discomfort while using the devices or muscle soreness after use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a stroke that affected one side of my brain.
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I can walk by myself for 5-10 minutes, even if I need help like a cane.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ankle Muscle Activation
Gait speed
Secondary outcome measures
Changes in paretic leg propulsive force
Other outcome measures
Changes in other lower extremity muscle activation
Changes in paretic leg loading (i.e., vertical ground reaction force)
Muscle Coordination

Trial Design

2Treatment groups
Experimental Treatment
Group I: NewGaitExperimental Treatment1 Intervention
Participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.
Group II: ControlExperimental Treatment1 Intervention
Participants will put on the Control device and walk on the treadmill and over ground. Participants may receive biofeedback of their gait patterns to engage them in the training.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,779 Total Patients Enrolled
79 Trials studying Stroke
5,369 Patients Enrolled for Stroke
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,378,120 Total Patients Enrolled
27 Trials studying Stroke
22,976 Patients Enrolled for Stroke
Chandramouli Krishnan, PT, PhDPrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

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

Are there any vacancies available for patients to participate in this trial?

"According to the details available on clinicaltrials.gov, this investigation is actively seeking eligible participants. The trial was initially disclosed on March 1st, 2024 and last revised on February 20th, 2024."

Answered by AI

What are the eligibility criteria for individuals who can participate in this medical research study?

"Interested individuals must have experienced a cerebrovascular accident and fall between 40 to 75 years old to be eligible for participation in this research study. The trial aims to enroll a total of 18 participants."

Answered by AI

What is the current number of individuals being enrolled in this research investigation?

"Yes, the information on clinicaltrials.gov indicates that this trial is actively seeking participants. The trial was first posted on March 1st, 2024 and last updated on February 20th, 2024. They are aiming to recruit 18 individuals from a single site."

Answered by AI

Are individuals above the age of 25 eligible for enrollment in this clinical trial?

"Eligible participants for this study must be aged between 40 and 75 years. Notably, there are a total of 40 trials available for individuals under 18 years old, while there are as many as 1085 trials catering to those over the age of 65."

Answered by AI
~12 spots leftby Dec 2024