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

Brain Injuries, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401645
• Other study ID #: E-974-17
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2023
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

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