Clinical trial NCT06184932: TeleRehab to Restore Upper Limb Function in People With Chronic TBI
Official title: TeleRehab to Restore Upper Limb Function in People With Chronic TBI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Upper Extremity Dysfunction
Disability Physical
Keywords: upper limb
telerehabilitation
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: New Jersey Commission on Brain Injury Research
First posted: 2023-12-29
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in the Box and Block Test
timeFrame: 4 weeks before intervention, immediately before intervention, and immediately after intervention
measure: Wolf Motor Function Test
timeFrame: 4 weeks before intervention, immediately before intervention, and immediately after intervention
Secondary outcomes:
measure: Quality of Life in Neurological Disorders Measurement System
timeFrame: 4 weeks before intervention, immediately before intervention, and immediately after intervention
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Peii Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: