Home-based Arm and Hand Exercise to Improve Upper Limb Function After Traumatic Brain Injury

NCT ID: NCT03401645

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-03-01

Brief Summary

The purpose of this study is to find out whether the Home-based Arm and Hand Exercise (HAHE) program improves functions of the upper limb that is affected after traumatic brain injury. HAHE is made up of exercises that simulate real-life tasks.

Detailed Description

Arm and hand dysfunction, although not widely recognized, is a common and devastating consequence of traumatic brain injury (TBI). Recommendations have been published that encourage clinicians to include upper extremity retraining within the TBI population; however, very little research exists that will help inform treatments for this population. There is urgency to broaden the scientific evidence critical to informing upper limb rehabilitation for TBI survivors. The proposed study will do just that by using a task-specific visuomotor exercise protocol that emphasizes upper limb movements which can be practiced by patients in their homes. This new home-based arm and hand exercise (HAHE) protocol is expected to improve functional recovery and quality of life among individuals with chronic upper limb impairment after moderate-to-severe TBI.

Conditions

Brain Injuries, Traumatic

Study Design

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

Study Groups

Treatment (Alarm Active)

Participants will be wearing the wrist device with an alarm timer that sends out signals every 5 minutes. The alarm is a buzzing noise and a vibration. Participants must turn off the alarm then perform a series of visuomotor tasks. This will be done for one hour, twice a day for two weeks.

Intervention: Device - Wrist Alarm; Behavioral - Home-based Arm and Hand Exercise

Group Type: EXPERIMENTAL

Wrist Alarm

Intervention Type: OTHER

Wrist device with alarm timer

Home-based Arm and Hand Exercise

Intervention Type: BEHAVIORAL

Repeated visuomotor tasks, unilateral arm and hand movements, bilateral arm and hand movements

Control (Sham Control)

Participants will perform the same tasks as the Alarm/Treatment group, but without the alarm timer. This is a series of visuomotor tasks for one hour, twice per day for two weeks.

Intervention: Behavioral - Home-based Arm and Hand Exercise

Group Type: SHAM_COMPARATOR

Home-based Arm and Hand Exercise

Intervention Type: BEHAVIORAL

Repeated visuomotor tasks, unilateral arm and hand movements, bilateral arm and hand movements

Interventions

Wrist Alarm

Wrist device with alarm timer

Intervention Type: OTHER

Home-based Arm and Hand Exercise

Repeated visuomotor tasks, unilateral arm and hand movements, bilateral arm and hand movements

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Time post injury: >12 Months
• Moderate to severe TBI, with one of the following (as confirmed by medical records):

1. Post-traumatic amnesia for over 24 hours

2. Trauma-related intracranial neuroimaging abnormalities (based on radiology reports of the head CT scan acquired acutely)

3. Loss of consciousness for over 30 minutes

4. Score of over 13 on the Glasgow Coma Scale (recorded in emergency dept, but not valid if patient was intubated, sedated or intoxicated)

• Has emerged from post-traumatic amnesia (as indicated by review of medical history documents)
• Cognitively oriented (score above 23 on the Mini Mental State Examination)
• One upper limb is more affected than the other, and participant reports impaired upper limb function because of the more affected limb
• The more affected limb is at Stage 3, 4 or 5 of Arm Recovery
• Be able to complete the sequence of the HAHE protocol independently, safely and accurately by the end of the therapist-guided training

Exclusion Criteria

• < 18 years old at the time of injury
• A history of previous neurological disorder such as stroke, seizure, multiple sclerosis, spinal cord injury, cerebral palsy, Parkinson's disease, or Alzheimer's disease. This is to assure that participants' deficits are secondary to TBI only.
• A history of significant psychiatric disorder such as schizophrenia, bipolar disorder, or obsessive-compulsive disorder. There may be potential cognitive changes due to such history, which may affect the ability in following the treatment protocol.
• A history of substance abuse requiring inpatient treatment. There may be potential cognitive changes due to such history, which may affect the ability in following the treatment protocol.
• The more affected limb is at the Stage 1, 2, 6, or 7 of Arm Recovery (Figure 2).
• Pain in the upper extremity during the upper limb function screening
• Active subluxation of the shoulders (i.e., the glenohumeral joint)
• Undergoing treatment for spasticity in the upper limb (e.g. botulinum toxin injection)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Peii Chen

Senior Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peii Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation

West Orange, New Jersey, United States

Countries

United States

Other Identifiers

E-974-17

Identifier Type: -

Identifier Source: org_study_id