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

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

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.

Study Overview

• Status: Unknown
• Conditions: Brain Injuries, Traumatic
• Intervention / Treatment: Other: Wrist Alarm; Behavioral: Home-based Arm and Hand Exercise

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Wrist Alarm; Wrist device with alarm timer; Behavioral: Home-based Arm and Hand Exercise; Repeated visuomotor tasks, unilateral arm and hand movements, bilateral arm and hand movements
Sham Comparator: 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	Behavioral: Home-based Arm and Hand Exercise; Repeated visuomotor tasks, unilateral arm and hand movements, bilateral arm and hand movements

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: E-974-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No