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

Not Applicable

Completed

• Conditions: Brain Injuries, Traumatic
• Interventions: Other: Wrist Alarm; Behavioral: Home-based Arm and Hand Exercise

• Registration Number: NCT03401645
• Lead Sponsor: Kessler Foundation

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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-17
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment (Alarm Active)	Wrist Alarm	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
Treatment (Alarm Active)	Home-based Arm and Hand Exercise	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
Control (Sham Control)	Home-based Arm and Hand Exercise	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

Primary Outcome Measures

Name	Time	Method
Wolf Motor Function Test - Functional Ability Scale (WMFT-FAS)	Week 7	Measures upper extremity motor ability through 15 timed and functional tasks.

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States