Traumatic Brain InjuryNCT06184932
TeleRehab to Restore Upper Limb Function in People With Chronic TBI
A study testing HAHE and Exergame in people with Traumatic Brain Injury and Upper Extremity Dysfunction, run by Kessler Foundation at 1 site in United States.
Trial summary
The study aims to inform the subsequent large-scale clinical trial focused on using telerehabilitation techniques and technologies to improve upper limb function and quality of life. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Traumatic Brain Injury, Upper Extremity Dysfunction, Disability Physical
- What is being tested?
- HAHE and Exergame
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 31 Mar 2025
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Time post injury > 12 months
- Moderate-to-severe TBI
- One upper limb (UL) is more affected than the other, and the participant reports impaired UL function because of the more affected limb.
- The more affected limb is at the Brunnstrom Stage 3, 4, or 5 of Arm Recovery .
- Meeting the following technology requirements: possessing and using a smartphone, Internet connection at home, and having a TV at home
Who cannot join
- < 18 years old at the time of injury
- A history of previous neurological disorder
- A history of substance abuse requiring inpatient treatment
- The more affected limb is at the Brunnstrom Stage 1, 2, 6, or 7 of Arm Recovery.
- Experiencing severe pain during the Brunnstrom Stage evaluation
- Active subluxation of the shoulders
- Living outside of the 50-mile radius of Kessler Foundation (West Orange, NJ)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Emma Kaplan, 973-243-6880, ekaplan@kesslerfoundation.org
About this study
The study aims to inform the subsequent large-scale clinical trial focused on using telerehabilitation techniques and technologies to improve upper limb function and quality of life.
Read the detailed description
Upper limb (UL) function is often impaired and not fully recovered after moderate-to-severe traumatic brain injury (TBI), leading to devastating consequences and reducing quality of life. Clinicians have been encouraged to include UL rehabilitation, but existing evidence is insufficient to inform specific treatments for the TBI population. There is urgency to broaden the scientific evidence critical to advancing UL rehabilitation for TBI survivors, especially those living in the community with chronic UL impairment.
The study will examine two UL exercise programs through tele-rehabilitation (TeleRehab) techniques. Both programs are focused on functional tasks and daily activities. One program is implemented directly in the real-life home environment, the home-based arm and hand exercise (HAHE) program. The other program is delivered through simulated real-world scenarios, the exercise video game (Exergame) program. The HAHE program consists of UL exercises based on real-life activities that involve materials and objects readily available at home or easily obtained in regular stores. The Exergame program packages UL exercises into game-like activities delivered through a non-immersive virtual reality device.
Individuals with chronic UL impairment after moderate-to-severe TBI will participate in the proposed study. They will be randomly assigned to the HAHE or the Exergame program. Patients will complete 30 sessions of the assigned program over 6 weeks at home, with no immediate supervision. An occupational therapist will review the progress, assist in goal setting, and provide consultation to patients at the beginning of each week via a video call. The investigators will determine which of the programs is effective, and whether the programs lead to similar or different outcomes.
- Being tested
- HAHE, Exergame
- Keywords
- upper limb, telerehabilitation
- 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.
HAHEBehavioural
Participants will self-initiate rehabilitative activities through the HAHE program.
ExergameBehavioural
Participants will self-initiate rehabilitative activities through the Exergame program.
| Study group | Role | What they receive |
|---|---|---|
| Home-based Arm and Hand Exercise (HAHE) | Experimental | An occupational therapist (OT) will incorporate participants' preference, goals, and current function to co-create UL exercise activities with participants. The exercise activities will be based on real-life activities that participants are familiar with. During the 6-week TeleRehab period, participants will complete 30 one-hour sessions of UL exercise activities, on their own without immediate supervision. Receives: Behavioral: HAHE |
| Exergame | Experimental | An occupational therapist (OT) will incorporate participants' preference, goals, and current function to select UL exercise activities with participants from the RehabKit program software. During the 6-week TeleRehab period, participants will complete 30 one-hour sessions of UL exercise activities, on their own without immediate supervision. Receives: Behavioral: Exergame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Box and Block Test
Participants will be seated at a table, face a rectangular box that is divided into two square compartments of equal dimensions on the left and right sides by means of a partition. At the beginning of the test, 150 1-inch blocks are in the same compartment. The task is to move as many blocks as possible, one at a time, from one compartment to the other using one arm only.
Participants will be assessed 4 weeks before intervention (Time 1), immediately before (Time 2) and immediately after intervention (Time 3). The investigators will measure the change between Time 1 and Time 2 (baseline change), and the change between Time 2 and Time 3 (treatment change). The outcome measure is the difference between the two changes.
Measured: 4 weeks before intervention, immediately before intervention, and immediately after intervention
Wolf Motor Function Test
The test quantitatively measures UL motor ability through 15 timed and functional tasks - forearm to table, forearm to box, extend elbow, extend elbow with weight, hand to table, hand to the box, reach and retrieve, lift can, lift pencil, lift paper clip, stack checkers, flip cards, turn key in lock, fold towel, and lift basket.
Participants will be assessed 4 weeks before intervention (Time 1), immediately before (Time 2) and immediately after intervention (Time 3). The investigators will measure the change between Time 1 and Time 2 (baseline change), and the change between Time 2 and Time 3 (treatment change). The outcome measure is the difference between the two changes.
Measured: 4 weeks before intervention, immediately before intervention, and immediately after intervention
Secondary outcomes (1)
Quality of Life in Neurological Disorders Measurement System
The standardized short forms for adults evaluate anxiety, depression, fatigue, UL function, lower limb function, cognitive function, emotional and behavioral dyscontrol, positive affect and well-being, sleep disturbance, ability to participate in social roles and activities, satisfaction with social roles and activities, stigma, and communication.
Participants will be assessed 4 weeks before intervention (Time 1), immediately before (Time 2) and immediately after intervention (Time 3). The investigators will measure the change between Time 1 and Time 2 (baseline change), and the change between Time 2 and Time 3 (treatment change). The outcome measure is the difference between the two changes.
Measured: 4 weeks before intervention, immediately before intervention, and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Commission on Brain Injury Research
- Responsible party
- Sponsor
- Investigators
- Peii Chen, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184932
- Sponsor's protocol ID
- E-1217-23
- Status last verified
- Jan 2024
- First submitted
- 5 Jul 2023
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TeleRehab to Restore Upper Limb Function in People With Chronic TBI
- ClinicalTrials.gov ID
- NCT06184932
- Acronym / sponsor ID
- E-1217-23
- Keywords
- upper limb, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- New Jersey Commission on Brain Injury Research
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 29 Dec 2023 (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 study aims to inform the subsequent large-scale clinical trial focused on using telerehabilitation techniques and technologies to improve upper limb function and quality of life.
Detailed description
Upper limb (UL) function is often impaired and not fully recovered after moderate-to-severe traumatic brain injury (TBI), leading to devastating consequences and reducing quality of life. Clinicians have been encouraged to include UL rehabilitation, but existing evidence is insufficient to inform specific treatments for the TBI population. There is urgency to broaden the scientific evidence critical to advancing UL rehabilitation for TBI survivors, especially those living in the community with chronic UL impairment.
The study will examine two UL exercise programs through tele-rehabilitation (TeleRehab) techniques. Both programs are focused on functional tasks and daily activities. One program is implemented directly in the real-life home environment, the home-based arm and hand exercise (HAHE) program. The other program is delivered through simulated real-world scenarios, the exercise video game (Exergame) program. The HAHE program consists of UL exercises based on real-life activities that involve materials and objects readily available at home or easily obtained in regular stores. The Exergame program packages UL exercises into game-like activities delivered through a non-immersive virtual reality device.
Individuals with chronic UL impairment after moderate-to-severe TBI will participate in the proposed study. They will be randomly assigned to the HAHE or the Exergame program. Patients will complete 30 sessions of the assigned program over 6 weeks at home, with no immediate supervision. An occupational therapist will review the progress, assist in goal setting, and provide consultation to patients at the beginning of each week via a video call. The investigators will determine which of the programs is effective, and whether the programs lead to similar or different outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based Arm and Hand Exercise (HAHE) | Experimental | Behavioral: HAHEAn occupational therapist (OT) will incorporate participants' preference, goals, and current function to co-create UL exercise activities with participants. The exercise activities will be based on real-life activities that participants are familiar with. During the 6-week TeleRehab period, participants will complete 30 one-hour sessions of UL exercise activities, on their own without immediate supervision. |
| Exergame | Experimental | Behavioral: ExergameAn occupational therapist (OT) will incorporate participants' preference, goals, and current function to select UL exercise activities with participants from the RehabKit program software. During the 6-week TeleRehab period, participants will complete 30 one-hour sessions of UL exercise activities, on their own without immediate supervision. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Time post injury > 12 months
- Moderate-to-severe TBI
- One upper limb (UL) is more affected than the other, and the participant reports impaired UL function because of the more affected limb.
- The more affected limb is at the Brunnstrom Stage 3, 4, or 5 of Arm Recovery .
- Meeting the following technology requirements: possessing and using a smartphone, Internet connection at home, and having a TV at home
Key exclusion criteria (7 listed)
- < 18 years old at the time of injury
- A history of previous neurological disorder
- A history of substance abuse requiring inpatient treatment
- The more affected limb is at the Brunnstrom Stage 1, 2, 6, or 7 of Arm Recovery.
- Experiencing severe pain during the Brunnstrom Stage evaluation
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 |
|---|---|---|
| HAHEParticipants will self-initiate rehabilitative activities through the HAHE program. | Behavioural | Home-based Arm and Hand Exercise (HAHE) |
| ExergameParticipants will self-initiate rehabilitative activities through the Exergame program. | Behavioural | Exergame |
Primary outcome
Change in the Box and Block Test
Time frame: 4 weeks before intervention, immediately before intervention, and immediately after intervention
Participants will be seated at a table, face a rectangular box that is divided into two square compartments of equal dimensions on the left and right sides by means of a partition. At the beginning of the test, 150 1-inch blocks are in the same compartment. The task is to move as many blocks as possible, one at a time, from one compartment to the other using one arm only. Participants will be assessed 4 weeks before intervention (Time 1), immediately before (Time 2) and immediately after intervention (Time 3). The investigators will measure the change between Time 1 and Time 2 (baseline change), and the change between Time 2 and Time 3 (treatment change). The outcome measure is the difference between the two changes.
Wolf Motor Function Test
Time frame: 4 weeks before intervention, immediately before intervention, and immediately after intervention
The test quantitatively measures UL motor ability through 15 timed and functional tasks - forearm to table, forearm to box, extend elbow, extend elbow with weight, hand to table, hand to the box, reach and retrieve, lift can, lift pencil, lift paper clip, stack checkers, flip cards, turn key in lock, fold towel, and lift basket. Participants will be assessed 4 weeks before intervention (Time 1), immediately before (Time 2) and immediately after intervention (Time 3). The investigators will measure the change between Time 1 and Time 2 (baseline change), and the change between Time 2 and Time 3 (treatment change). The outcome measure is the difference between the two changes.
1 secondary outcome
Quality of Life in Neurological Disorders Measurement System
Time frame: 4 weeks before intervention, immediately before intervention, and immediately after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
Related trials for Traumatic Brain Injury
Not yet recruitingObservational study
A Prospective Study of Cognitive Changes in Retired and Late-Career Professional Soccer Players
Cognitive Impairment, Chronic Traumatic Encephalopathy (CTE)
Not yet recruiting
Implementation Study on Hospital-to-home Advanced Rehabilitation Technologies (ART)
Brain Injuries
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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 HAHE and Exergame in people with Traumatic Brain Injury and Upper Extremity Dysfunction, 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma Kaplan (973-243-6880, ekaplan@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Box and Block Test (time frame: 4 weeks before intervention, immediately before intervention, and immediately after intervention). The study lists 2 primary outcomes in all. 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 5 Jan 2024.