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

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ClinicalTrials.gov Identifier: NCT03401645
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Peii Chen, Kessler Foundation

Tracking Information
First Submitted Date  ICMJE January 2, 2018
First Posted Date  ICMJE January 17, 2018
Last Update Posted Date November 25, 2019
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
Wolf Motor Function Test - Functional Ability Scale (WMFT-FAS) [ Time Frame: Week 7 ]
Measures upper extremity motor ability through 15 timed and functional tasks.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home-based Arm and Hand Exercise to Improve Upper Limb Function After Traumatic Brain Injury
Official Title  ICMJE Home-based Arm and Hand Exercise (HAHE) to Improve Upper Limb Function After Traumatic Brain Injury
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Brain Injuries, Traumatic
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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

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

    Intervention: Behavioral: Home-based Arm and Hand Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03401645
Other Study ID Numbers  ICMJE E-974-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peii Chen, Kessler Foundation
Study Sponsor  ICMJE Kessler Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peii Chen, PhD Kessler Foundation
PRS Account Kessler Foundation
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP