Recruiting

TeleRehab

Sponsor:

Kessler Foundation

Code:

NCT06184932

Conditions

Traumatic Brain Injury

Upper Extremity Dysfunction

Disability Physical

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

HAHE

Exergame

Study Details

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

Study ID

NCT06184932

Start date

Apr 1, 2023

Status verified date

Jan, 2024

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

HAHE

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

Exergame

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

Primary outcome measure

  • Change in the Box and Block Test [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Emma Kaplan

973-243-6880ekaplan@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Emma Kaplan

973-243-6880ekaplan@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Jan 5, 2024

Last verified

Jan, 2024

Keywords

  • upper limb
  • telerehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2024-01-05.