Brain Injuries, TraumaticNCT03401645
Home-based Arm and Hand Exercise to Improve Upper Limb Function After Traumatic Brain Injury
A study testing Wrist Alarm and Home-based Arm and Hand Exercise in people with Brain Injuries, Traumatic, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Wrist Alarm and Home-based Arm and Hand Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- < 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-based Arm and Hand Exercise (HAHE) to Improve Upper Limb Function After Traumatic Brain Injury
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.
Read the 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.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Wrist Alarm, Home-based Arm and Hand Exercise
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist AlarmOther
Wrist device with alarm timer
Home-based Arm and Hand ExerciseBehavioural
Repeated visuomotor tasks, unilateral arm and hand movements, bilateral arm and hand movements
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Wrist Alarm; Behavioral: 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 Receives: Behavioral: Home-based Arm and Hand Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test - Functional Ability Scale (WMFT-FAS)
Measures upper extremity motor ability through 15 timed and functional tasks.
Measured: Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Jul 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peii Chen, Kessler Foundation
- Investigators
- Peii Chen, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401645
- Sponsor's protocol ID
- E-974-17
- Status last verified
- Mar 2023
- First submitted
- 2 Jan 2018
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Arm and Hand Exercise (HAHE) to Improve Upper Limb Function After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03401645
- Acronym / sponsor ID
- E-974-17
- Conditions
- Brain Injuries, Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (Alarm Active) | Experimental | Other: Wrist Alarm, Behavioral: Home-based Arm and Hand ExerciseParticipants 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 |
| Control (Sham Control) | Sham comparator | Behavioral: Home-based Arm and Hand ExerciseParticipants 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Time post injury: >12 Months
- Moderate to severe TBI, with one of the following (as confirmed by medical records):
- 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
Key exclusion criteria (8 listed)
- < 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist AlarmWrist device with alarm timer | Other | Treatment (Alarm Active) |
| Home-based Arm and Hand ExerciseRepeated visuomotor tasks, unilateral arm and hand movements, bilateral arm and hand movements | Behavioural | Control (Sham Control), Treatment (Alarm Active) |
Primary outcome
Wolf Motor Function Test - Functional Ability Scale (WMFT-FAS)
Time frame: Week 7
Measures upper extremity motor ability through 15 timed and functional tasks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peii Chen, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist Alarm and Home-based Arm and Hand Exercise in people with Brain Injuries, Traumatic, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test - Functional Ability Scale (WMFT-FAS) (time frame: Week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.