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Clinical Trials/NCT03401645
NCT03401645
Completed
N/A

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

Kessler Foundation1 site in 1 country12 target enrollmentJuly 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Brain Injuries, Traumatic
Sponsor
Kessler Foundation
Enrollment
12
Locations
1
Primary Endpoint
Wolf Motor Function Test - Functional Ability Scale (WMFT-FAS)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
March 1, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Principal Investigator
Principal Investigator

Peii Chen

Senior Research Scientist

Kessler Foundation

Eligibility Criteria

Inclusion Criteria

  • Time post injury: \>12 Months
  • Moderate to severe TBI, with one of the following (as confirmed by medical records):
  • Post-traumatic amnesia for over 24 hours
  • Trauma-related intracranial neuroimaging abnormalities (based on radiology reports of the head CT scan acquired acutely)
  • Loss of consciousness for over 30 minutes
  • 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

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)

Outcomes

Primary Outcomes

Wolf Motor Function Test - Functional Ability Scale (WMFT-FAS)

Time Frame: Week 7

Measures upper extremity motor ability through 15 timed and functional tasks.

Study Sites (1)

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