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Trial record 4 of 303 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03401645
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Brain Injuries, Traumatic Other: Wrist Alarm Behavioral: Home-based Arm and Hand Exercise

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home-based Arm and Hand Exercise (HAHE) to Improve Upper Limb Function After Traumatic Brain Injury
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

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
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

Behavioral: Home-based Arm and Hand Exercise
Repeated visuomotor tasks, unilateral arm and hand movements, bilateral arm and hand movements


Outcome Measures

Primary Outcome Measures :
  1. Wolf Motor Function Test - Functional Ability Scale (WMFT-FAS) [ Time Frame: Week 7 ]
    Measures upper extremity motor ability through 15 timed and functional tasks.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401645


Contacts
Contact: Jenny Masmela 9733243564 jmasmela@kesslerfoundation.org

Locations
United States, New Jersey
Kessler Foundation Research Center Recruiting
West Orange, New Jersey, United States, 07052
Contact: Jenny Masmela, BA    973-324-3564    jmasmela@kesslerfoundation.org   
Contact: Anna Barrett, MD    973 324-3569      
Sponsors and Collaborators
Kessler Foundation
Investigators
Principal Investigator: Peii Chen, PhD Kessler Foundation
More Information

Responsible Party: Peii Chen, Senior Research Scientist, Kessler Foundation
ClinicalTrials.gov Identifier: NCT03401645     History of Changes
Other Study ID Numbers: E-974-17
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System