Status:
COMPLETED
Home-based Arm and Hand Exercise to Improve Upper Limb Function After Traumatic Brain Injury
Lead Sponsor:
Kessler Foundation
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
20-60 years
Phase:
NA
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...
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 incl...
Eligibility Criteria
Inclusion
- 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
- Be able to complete the sequence of the HAHE protocol independently, safely and accurately by the end of the therapist-guided training
Exclusion
- \< 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)
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03401645
Start Date
July 1 2017
End Date
March 1 2019
Last Update
March 8 2023
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052