NCT03401645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

January 2, 2018

Last Update Submit

March 7, 2023

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

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

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

    Week 7

Study Arms (2)

Treatment (Alarm Active)

EXPERIMENTAL

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 AlarmBehavioral: Home-based Arm and Hand Exercise

Control (Sham Control)

SHAM COMPARATOR

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

Interventions

Wrist AlarmOTHER

Wrist device with alarm timer

Treatment (Alarm Active)
Home-based Arm and Hand ExerciseBEHAVIORAL

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

Control (Sham Control)Treatment (Alarm Active)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \< 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Peii Chen, PhD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 17, 2018

Study Start

July 1, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

US(1)