Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT06184932
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TeleRehab to Restore Upper Limb Function in People With Chronic TBI
Sponsor:
Kessler Foundation
Organization:
Study Overview
Official Title:
TeleRehab to Restore Upper Limb Function in People With Chronic TBI
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: