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Procedure

Prism Adaptation Therapy + Electrical Stimulation for Stroke Rehabilitation

N/A
Recruiting
Led By Fisayo Aloba, PT, DPT
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Young Adults Able Bodied (YAB) Individuals aged 18-30 years, healthy without any physical disability or neurological disorder
Older Adults Able-Bodied Individuals (OAB) aged 45-90 years, healthy without any physical disability or neurological disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-training and immediately after training session
Awards & highlights

Study Summary

This trial studies how prism training and electrical stimulation can improve how the brain processes visual information and help people with walking problems.

Who is the study for?
This trial is for healthy young adults (18-30 years), older adults (45-90 years) without disabilities, and individuals aged 40-90 who've had a right hemisphere stroke over 3 months ago. Stroke survivors must have spatial neglect, be able to walk more than 10m, and have certain arm strength. Exclusions include other neurological disorders, severe medical conditions, pregnancy, uncontrolled hypertension, or skin issues where devices attach.Check my eligibility
What is being tested?
The study tests how prism adaptation therapy (PAT), with or without electrical stimulation (E-stim), affects visuospatial behavior and walking in people after a stroke. It also looks at changes in the motor system's neurophysiology. Participants will receive PAT combined with either real or sham E-stim alongside gait training.See study design
What are the potential side effects?
Possible side effects may include discomfort from the electrical stimulation device or irritation at the site of electrode placement. Prism adaptation therapy is generally considered low-risk but could potentially cause mild disorientation or dizziness initially.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18-30 years old and do not have any physical disabilities or neurological disorders.
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I am between 45-90 years old, healthy, and do not have any physical disabilities or neurological disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-training and immediately after training session
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-training and immediately after training session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in corticospinal excitability (single pulse TMS)
Change in intracortical excitability [paired pulse transcranial Magnetic Stimulation (TMS)]
Change in visuospatial pointing behavior
Secondary outcome measures
Change in computerized line bisection task
Change in spatial neglect deficits
Change in the Catherine Bergego Scale (CBS)
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Stroke with Spatial Neglect (SN) individualsExperimental Treatment3 Interventions
40-90 years individuals with more than 3 months following right hemisphere stroke.
Group II: Old Able-Bodied individualsActive Control2 Interventions
45-90 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
Group III: Young Able-Bodied individualsActive Control2 Interventions
18-30 years old able-bodied individuals (healthy without any physical disability or neurological disorder).

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,622 Total Patients Enrolled
29 Trials studying Stroke
347,997 Patients Enrolled for Stroke
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,554 Total Patients Enrolled
171 Trials studying Stroke
83,823 Patients Enrolled for Stroke
Fisayo Aloba, PT, DPTPrincipal InvestigatorEmory University

Frequently Asked Questions

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

Is the participant requirement for this study age-inclusive?

"Participants must be of legal age and younger than 90 years old to meet the trial's criteria for enrollment."

Answered by AI

What characterizes an ideal candidate for this experiment?

"The prerequisites for taking part in this clinical study are to have had a stroke, and be between 18 years old and 90. This research programme is seeking 35 participants."

Answered by AI

How many individuals have enrolled in this clinical experiment?

"Affirmative. According to the information located on clinicaltrials.gov, this trial is presently recruiting participants; it was initially posted in April 11th 2023 and last updated in September 22nd of that same year. The research requires 35 volunteers from 3 distinct locations."

Answered by AI

Is enrollment open in this research initiative?

"Affirmative. According to the information on clinicaltrials.gov, this analysis is still gathering participants. This research was first published on April 11th 2023 and most recently modified on September 22nd of the same year. The trial requires 35 volunteers at 3 separate sites."

Answered by AI

What is the main goal of this experiment?

"The primary aim of this clinical trial - to be evaluated over a pre-training and immediately post-training session timeline - is to assess the change in intracortical excitability through paired pulse transcranial magnetic stimulation (TMS). Secondary objectives include an analysis of shift in computerized line bisection task performance, Catherine Bergego Scale scores, and weight bearing asymmetry. In particular, stroke patients will have their vertical ground reaction forces measured on a dual belt instrumented treadmill during 3D motion capture for interlimb force comparisons while standing or walking."

Answered by AI
~13 spots leftby Dec 2024