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

Description

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 Start Date

July, 01 2017

Estimated Completion Date

June 2019

Interventions

  • Other: Wrist Alarm
  • Behavioral: Home-based Arm and Hand Exercise

Study ID

Kessler Foundation -- E-974-17

Status

Unknown

Trial ID

NCT03401645

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

60

Sponsor

Kessler Foundation

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)

Gender

All

Ages

20 Years to 60 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Kessler Foundation Research Center - West Orange, New Jersey 50.6 miles Jenny Masmela BA 973-324-3564 jmasmela@kesslerfoundation.org

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