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Behavioral Intervention

Exergame for Traumatic Brain Injury

N/A

Recruiting

Led By Peii Chen, PhD

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

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

Must have

One upper limb (UL) is more affected than the other, and the participant reports impaired UL function because of the more affected limb

The more affected limb is at the Brunnstrom Stage 3, 4, or 5 of Arm Recovery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks before intervention, immediately before intervention, and immediately after intervention

Awards & highlights

Study Summary

This trial is trying to gather information for a bigger trial that will use technology to help people improve their arm function and overall quality of life.

Who is the study for?

This trial is for individuals with chronic traumatic brain injury (TBI) who are experiencing difficulties with arm and hand functions. Specific eligibility criteria details are not provided, but typically participants must meet certain health conditions to be included.Check my eligibility

What is being tested?

The study is testing the effectiveness of telerehabilitation techniques, including an 'Exergame' and a method called HAHE, in improving upper limb function for people with TBI. It's a preliminary step towards a larger clinical trial.See study design

What are the potential side effects?

Potential side effects are not detailed in the information provided. However, as this trial involves rehabilitation exercises, possible side effects may include muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

One of my arms is weaker than the other and it affects how I use it.

Select...

My arm's movement is moderately impaired but improving.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks before intervention, immediately before intervention, and immediately after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks before intervention, immediately before intervention, and immediately after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks before intervention, immediately before intervention, and immediately after intervention 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 the Box and Block Test

Wolf Motor Function Test

Secondary outcome measures

Quality of Life in Neurological Disorders Measurement System

Trial Design

2Treatment groups

Experimental Treatment

Group I: Home-based Arm and Hand Exercise (HAHE)Experimental Treatment1 Intervention

An occupational therapist (OT) will incorporate participants' preference, goals, and current function to co-create UL exercise activities with participants. The exercise activities will be based on real-life activities that participants are familiar with. During the 6-week TeleRehab period, participants will complete 30 one-hour sessions of UL exercise activities, on their own without immediate supervision.

Group II: ExergameExperimental Treatment1 Intervention

An occupational therapist (OT) will incorporate participants' preference, goals, and current function to select UL exercise activities with participants from the RehabKit program software. During the 6-week TeleRehab period, participants will complete 30 one-hour sessions of UL exercise activities, on their own without immediate supervision.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exergame

2014

N/A

~210

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor

174 Previous Clinical Trials

10,678 Total Patients Enrolled

New Jersey Commission on Brain Injury ResearchOTHER

5 Previous Clinical Trials

116 Total Patients Enrolled

Peii Chen, PhDPrincipal InvestigatorKessler Foundation

3 Previous Clinical Trials

36 Total Patients Enrolled

Frequently Asked Questions

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

Am I eligible to participate in this research study?

"To be considered eligible for enrollment in this clinical trial, prospective participants must have a documented history of traumatic brain injury and fall within the age range of 45 to 75 years old. The study aims to recruit a total of 60 patients."

Answered by AI

What is the current number of participants being enrolled in this clinical trial?

"Indeed, as indicated on clinicaltrials.gov, this research is actively seeking eligible participants. The initial posting of the study was on April 1st, 2023 and it underwent its most recent update on December 26th, 2023. In total, the trial aims to enroll a cohort of 60 patients from one designated location."

Answered by AI

Is the age limit for participation in this medical study set at under 75 years?

"In adherence to the eligibility requirements for this research study, potential participants must be at least 45 years old and no more than 75 years old in order to enroll."

Answered by AI

Is the enrollment for this study currently accepting new participants?

"Indeed, the information obtained from clinicaltrials.gov verifies that this trial is currently in the recruitment phase. The original posting date for this study was April 1st, 2023, and it was last modified on December 26th, 2023. The trial aims to enroll a total of 60 participants at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TeleRehab to Restore Upper Limb Function in People With Chronic TBI

2023. "TeleRehab to Restore Upper Limb Function in People With Chronic TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06184932.