TeleRehab to Restore Upper Limb Function in People With Chronic TBI

NCT ID: NCT06184932

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-03-31

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.

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.

Conditions

Traumatic Brain Injury; Upper Extremity Dysfunction; Disability Physical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

HAHE

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Exergame

Intervention Type: BEHAVIORAL

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

Interventions

HAHE

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

Intervention Type: BEHAVIORAL

Exergame

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New Jersey Commission on Brain Injury Research

OTHER

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peii Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation

West Orange, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emma Kaplan

Role: CONTACT

ekaplan@kesslerfoundation.org

973-243-6880

Facility Contacts

Emma Kaplan

Role: primary

ekaplan@kesslerfoundation.org

973-243-6880

Other Identifiers

E-1217-23

Identifier Type: -

Identifier Source: org_study_id