TeleRehab to Restore Upper Limb Function in People With Chronic TBI

NCT06184932 | Unknown DMC

• 1 other identifier: E-1217-23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to inform the subsequent large-scale clinical trial focused on using telerehabilitation techniques and technologies to improve upper limb function and quality of life.

Conditions

Traumatic Brain Injury; Upper Extremity Dysfunction; Disability Physical

Keywords

upper limb; telerehabilitation

Outcome Measures

Primary Outcomes (2)

• Change in the Box and Block Test

  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

  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 Outcomes (1)

• Quality of Life in Neurological Disorders Measurement System

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

Study Arms (2)

Home-based Arm and Hand Exercise (HAHE)

EXPERIMENTAL

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.

Behavioral: HAHE

Exergame

EXPERIMENTAL

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.

Behavioral: Exergame

Interventions

HAHE BEHAVIORAL

Participants will self-initiate rehabilitative activities through the HAHE program.

Home-based Arm and Hand Exercise (HAHE)

Exergame BEHAVIORAL

Participants will self-initiate rehabilitative activities through the Exergame program.

Exergame

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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)

Sponsors & Collaborators

• Kessler Foundation: lead
• New Jersey Commission on Brain Injury Research: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Peii Chen, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Kaplan

CONTACT

973-243-6880; ekaplan@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: December 29, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

US (1)