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Behavioural Intervention

Treadmill gait training with GaitBetter for Stroke

N/A

Recruiting

Led By Paolo Bonato, PhD

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline scores at post-intervention (after 5 weeks)

Awards & highlights

Study Summary

This trial will test a new gait rehabilitation system for stroke patients.

Eligible Conditions

Stroke
Hemiplegia
Hemiplegic Gait

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline scores at post-intervention (after 5 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline scores at post-intervention (after 5 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline scores at post-intervention (after 5 weeks) 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 (in chronic stroke survivors, Aim 2)

10 meter walk test (in subacute stroke survivors, Aim 3)

Aim 3: Balance Evaluation Systems Test (mini-BESTest, in subacute stroke survivors, Aim 3)

+3 more

Secondary outcome measures

Cerebrovascular accident

Stance time (in subacute stroke survivors, Aim 3)

Step length (in chronic stroke survivors, Aim 2)

+7 more

Other outcome measures

12-Item Short Form Health Survey (SF-12) (in chronic stroke survivors, Aim 2)

Cerebrovascular accident

2-minutes walk test (2mwt) (in chronic stroke survivors, Aim 2)

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivorsExperimental Treatment2 Interventions

The investigators propose a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.

Group II: Aim 2: Efficacy of the GaitBetter to improve motor-cognitive function of chronic stroke survivorsExperimental Treatment1 Intervention

The investigators propose a single-arm, non-randomized study to test the hypothesis that the GaitBetter training is effective in improving gait and cognition in individuals with chronic stroke. This design was chosen given the expected stability of functional recovery in this population.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor

135 Previous Clinical Trials

10,979 Total Patients Enrolled

25 Trials studying Stroke

933 Patients Enrolled for Stroke

GoldenGait LTDUNKNOWN

Paolo Bonato, PhDPrincipal InvestigatorHarvard Medical School (HMS and HSDM)

22 Previous Clinical Trials

654 Total Patients Enrolled

10 Trials studying Stroke

247 Patients Enrolled for Stroke

Frequently Asked Questions

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

Would I be fitting to partake in this medical experiment?

"This experiment requires 76 adults aged 18-85 to suffer from hemiplegia. Selected participants must have obtained medical clearance, be male or female of the specified age range and have experienced a single sided ischemic or hemorrhagic stroke in the past 8 weeks; additionally they need to demonstrate an ability to traverse at least 15 metres with/without assistive technology (FIM walk subsection levels 6 and 7)."

Answered by AI

Is the research project open to elderly individuals?

"To enroll in this medical trial, patients must be between 18 and 85 years old. There are 47 trials accepting minors while 1046 studies allow individuals over 65 to participate."

Answered by AI

How many individuals are undergoing this research endeavor?

"Affirmative. Clinicaltrials.gov's data confirms that this clinical trial, which was initially published on July 23rd 2021, is presently recruiting participants. Approximately 76 individuals are needed to enrol at one medical centre."

Answered by AI

What objectives is this clinical trial seeking to fulfill?

"The main metric for evaluating success at the conclusion of this trial is a Change from baseline score with regards to Functional Independence Measure (FIM) in subacute stroke patients. Ancillary measurements include Stance Time, Swing Time and Step Symmetry - all assessed using 3D motion capture systems - as they pertain specifically to chronic and subacute stroke survivors."

Answered by AI

Are applications for this experiment still being accepted?

"Affirmative. The clinicaltrials.gov website expresses that this study has openings for 76 patients, and was first posted on July 23rd 2021 before being updated most recently on August 4th 2022. There is only one recruiting site associated with the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.

Paolo Bonato 2021. "GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04625127.