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

Primary Purpose

Brain Injuries, Traumatic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wrist Alarm

Home-based Arm and Hand Exercise

About this trial

This is an interventional treatment trial for Brain Injuries, Traumatic

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment (Alarm Active)

Control (Sham Control)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03401645

First Posted

January 2, 2018

Last Updated

March 7, 2023

Sponsor

Kessler Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03401645

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

March 1, 2019 (Actual)

Study Completion Date

March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injuries, Traumatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (Alarm Active)

Arm Type

Experimental

Arm Description

Arm Title

Control (Sham Control)

Arm Type

Sham Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Wrist Alarm

Intervention Description

Wrist device with alarm timer

Intervention Type

Behavioral

Intervention Name(s)

Home-based Arm and Hand Exercise

Intervention Description

Repeated visuomotor tasks, unilateral arm and hand movements, bilateral arm and hand movements

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Week 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peii Chen, PhD

Organizational Affiliation

Kessler Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kessler Foundation

City

West Orange

State/Province

New Jersey

ZIP/Postal Code

07052

Country

United States

12. IPD Sharing Statement

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

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