- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06184932
TeleRehab to Restore Upper Limb Function in People With Chronic TBI
Study Overview
Status
Intervention / Treatment
Detailed Description
Upper limb (UL) function is often impaired and not fully recovered after moderate-to-severe traumatic brain injury (TBI), leading to devastating consequences and reducing quality of life. Clinicians have been encouraged to include UL rehabilitation, but existing evidence is insufficient to inform specific treatments for the TBI population. There is urgency to broaden the scientific evidence critical to advancing UL rehabilitation for TBI survivors, especially those living in the community with chronic UL impairment.
The study will examine two UL exercise programs through tele-rehabilitation (TeleRehab) techniques. Both programs are focused on functional tasks and daily activities. One program is implemented directly in the real-life home environment, the home-based arm and hand exercise (HAHE) program. The other program is delivered through simulated real-world scenarios, the exercise video game (Exergame) program. The HAHE program consists of UL exercises based on real-life activities that involve materials and objects readily available at home or easily obtained in regular stores. The Exergame program packages UL exercises into game-like activities delivered through a non-immersive virtual reality device.
Individuals with chronic UL impairment after moderate-to-severe TBI will participate in the proposed study. They will be randomly assigned to the HAHE or the Exergame program. Patients will complete 30 sessions of the assigned program over 6 weeks at home, with no immediate supervision. An occupational therapist will review the progress, assist in goal setting, and provide consultation to patients at the beginning of each week via a video call. The investigators will determine which of the programs is effective, and whether the programs lead to similar or different outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emma Kaplan
- Phone Number: 973-243-6880
- Email: ekaplan@kesslerfoundation.org
Study Locations
-
-
New Jersey
-
West Orange, New Jersey, United States, 07052
- Recruiting
- Kessler Foundation
-
Contact:
- Emma Kaplan
- Phone Number: 973-243-6880
- Email: ekaplan@kesslerfoundation.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Time post injury > 12 months
- Moderate-to-severe TBI
- 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 .
- Meeting the following technology requirements: possessing and using a smartphone, Internet connection at home, and having a TV at home
Exclusion Criteria:
- < 18 years old at the time of injury
- A history of previous neurological disorder
- A history of substance abuse requiring inpatient treatment
- The more affected limb is at the Brunnstrom Stage 1, 2, 6, or 7 of Arm Recovery.
- Experiencing severe pain during the Brunnstrom Stage evaluation
- Active subluxation of the shoulders
- Living outside of the 50-mile radius of Kessler Foundation (West Orange, NJ)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home-based Arm and Hand Exercise (HAHE)
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.
|
Participants will self-initiate rehabilitative activities through the HAHE program.
|
Experimental: Exergame
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.
|
Participants will self-initiate rehabilitative activities through the Exergame program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Box and Block Test
Time Frame: 4 weeks before intervention, immediately before intervention, and immediately after intervention
|
Participants will be seated at a table, face a rectangular box that is divided into two square compartments of equal dimensions on the left and right sides by means of a partition. At the beginning of the test, 150 1-inch blocks are in the same compartment. The task is to move as many blocks as possible, one at a time, from one compartment to the other using one arm only. Participants will be assessed 4 weeks before intervention (Time 1), immediately before (Time 2) and immediately after intervention (Time 3). The investigators will measure the change between Time 1 and Time 2 (baseline change), and the change between Time 2 and Time 3 (treatment change). The outcome measure is the difference between the two changes. |
4 weeks before intervention, immediately before intervention, and immediately after intervention
|
Wolf Motor Function Test
Time Frame: 4 weeks before intervention, immediately before intervention, and immediately after intervention
|
The test quantitatively measures UL motor ability through 15 timed and functional tasks - forearm to table, forearm to box, extend elbow, extend elbow with weight, hand to table, hand to the box, reach and retrieve, lift can, lift pencil, lift paper clip, stack checkers, flip cards, turn key in lock, fold towel, and lift basket. Participants will be assessed 4 weeks before intervention (Time 1), immediately before (Time 2) and immediately after intervention (Time 3). The investigators will measure the change between Time 1 and Time 2 (baseline change), and the change between Time 2 and Time 3 (treatment change). The outcome measure is the difference between the two changes. |
4 weeks before intervention, immediately before intervention, and immediately after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life in Neurological Disorders Measurement System
Time Frame: 4 weeks before intervention, immediately before intervention, and immediately after intervention
|
The standardized short forms for adults evaluate anxiety, depression, fatigue, UL function, lower limb function, cognitive function, emotional and behavioral dyscontrol, positive affect and well-being, sleep disturbance, ability to participate in social roles and activities, satisfaction with social roles and activities, stigma, and communication. Participants will be assessed 4 weeks before intervention (Time 1), immediately before (Time 2) and immediately after intervention (Time 3). The investigators will measure the change between Time 1 and Time 2 (baseline change), and the change between Time 2 and Time 3 (treatment change). The outcome measure is the difference between the two changes. |
4 weeks before intervention, immediately before intervention, and immediately after intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peii Chen, PhD, Kessler Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-1217-23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Traumatic Brain Injury
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Hospital Sirio-LibanesUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationUnknownBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueNot yet recruitingTBI (Traumatic Brain Injury)France
-
BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
Queen Mary University of LondonCompleted
-
Northeastern UniversityBrandeis UniversityRecruitingTraumatic Brain Injury | Mild Traumatic Brain Injury | TBI | Moderate Traumatic Brain InjuryUnited States