Cerebral StrokeNCT06069999
Telerehabilitation Early After CNS Injury
A study testing HandyMotion Treatment Program in people with Cerebral Stroke and Traumatic Brain Injury, run by TRCare, Inc. at 5 sites in United States.
Trial summary
The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke, traumatic brain injury (TBI) and/or spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Stroke, Traumatic Brain Injury, Spinal Cord Injuries
- What is being tested?
- HandyMotion Treatment Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 May 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- CNS injury with onset in the prior 90 days
- For stroke: Stroke that is radiologically verified and due to ischemia or to intracerebral hemorrhage.
- For traumatic brain injury: History that is consistent with TBI; and score on the Revised Rancho Levels of Cognitive Functioning Scale is at least 6 out of 10.
- For spinal cord injury: Traumatic or nontraumatic, incomplete cervical SCI.
- At least one arm must have motor deficits that are neither very mild nor devastating (dense arm plegia). Operationally, this requires that the Visit 1 Box \& Block Test score is at least 1 block, but no more than 30 blocks, in 60 seconds.
Show all 10Show fewer
- Possess enough arm movement to participate in therapy, including able to hold the HandyMotion device in the paretic hand(s), using an assistive device if needed.
- Informed consent signed by the subject (no surrogate consent permitted for this study)
- Able to follow simple instructions
- Study participation is not likely to be significantly limited by agitated behavior
Who cannot join
- A major, active, coexistent neurological or psychiatric disease that would limit study participation, e.g., advanced dementia or active psychosis
- Expectation that patient's cognitive status will likely interfere substantially with playing assigned games or exercises
- Deficits in communication that interfere with reasonable study participation
- Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
- Subject does not speak sufficient English to comply with study procedures
- Shoulder pain that in the judgement of the study team is likely to substantially limit the amount of TR therapy completed
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Brooks Rehabilitation
Jacksonville, Florida, 32216
California Rehabilitation Institute
Los Angeles, California, 90095
Jefferson Moss-Magee Rehabilitation
Philadelphia, Pennsylvania, 19102
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91769
University of Utah - Craig H. Neilsen Rehabilitation Hospital
Salt Lake City, Utah, 84108
About this study
Official title: Bedside Telerehabilitation Early After CNS Injury
The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke, traumatic brain injury (TBI) and/or spinal cord injury (SCI). The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period. Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room. HandyMotion is a sensor-based training system that can connect to the TV set in the hospital room, enabling patients to access their therapy training program to practice rehab-oriented games and exercises ad libitum, at any time of the day.
Read the detailed description
This clinical trial is designed to address 3 specific aims:
Aim 1: To measure the safety of daily bedside telerehabilitation.
Aim 2: To measure the feasibility of daily bedside telerehabilitation.
Aim 3: To derive a preliminary estimate of motor and functional outcomes in patients engaged in daily bedside telerehabilitation. This is an uncontrolled pilot study, and so it is understood that such measures cannot be attributed to the telerehabilitation intervention, however, these measures will describe the clinical course of a patient engaged in this intervention.
Telerehabilitation therapy is delivered over the course of the inpatient rehabilitation stay. A therapist-facing web portal is used for treatment planning and patient monitoring. The treatment approach was initially designed based on an upper-extremity task-specific training manual and Accelerated Skill Acquisition Program.
Each daily 45-minute treatment session is created by a licensed OT or PT and includes:
- At least 15 min/day of upper extremity exercises. In addition, therapists have the option to incorporate standard exercise equipment (e.g., Theraband or dowels) that can be incorporated into assigned exercises.
- At least 15 min/day of functional training through games. The study provides 2 controllers with 5 different input devices that are available to drive game play. Games stress various motor control features (e.g., varying movement speed, range of motion, target size, extent of visuomotor tracking, or level of cognitive demand), which are selected and adjusted by the therapist.
- If applicable, 5 minutes/day of stroke education. The education content targets five categories (Stroke Risk Factors, Stroke Prevention, Effects of Stroke, Diet, and Exercise) and corresponds to the Stroke Knowledge Exam.
The remaining 10-15 minutes consist of additional exercises and games, per the judgment of the licensed OT or PT.
- Being tested
- HandyMotion Treatment Program
- Keywords
- Stroke, Traumatic Brain Injuries, Spinal Cord Injuries, Telerehabilitation, Brain Plasticity, Telehealth
- Medical subject headings
- Stroke, Brain Injuries, Traumatic, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HandyMotion Treatment ProgramDevice
A pair of sensor-based wireless remote controllers to allow the performance of functional exercises and games that target arm movement.
| Study group | Role | What they receive |
|---|---|---|
| TR Bedside Telerehabilitation | Experimental | Participants will be assigned 45-minutes of therapy training exercises each day for 7 days a week up to 4 weeks or until discharge.
Participants will use the HandyMotion device to interact with the telerehabilitation program displayed on the TV set in the patient room. Receives: Device: HandyMotion Treatment Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of daily beside telerehabilitation based on incidence of treatment-emergent adverse events as assessed by regular review of the medical record and patient interview
Safety will be measured in terms of adverse events (AEs) deemed related to use of the telerehabilitation system on a probable or definite basis.
Measured: "For approximately 4 weeks, up until discharge"
Secondary outcomes (2)
Feasibility of daily bedside telerehabilitation based on measurement of patient compliance, as determined by reviewing electronic records of device usage
Feasibility will be measured in terms of patient compliance, specifically the fraction of days where a patient is assigned to do bedside telerehabilitation and initiates a treatment session. Any factors related to reduced compliance, including technical and medical factors, will be recorded.
Feasibility is a composite measure. It is descriptive, so that all of these observations can be combined into a single outcome.
Measured: "baseline" and "immediately after end of treatment"
Box and Blocks Test
Measure of Upper Extremity Function by assessing unilateral gross manual dexterity.
Participants will be asked to perform the test twice for each side to assess bilateral gross manual dexterity. Participants will be asked to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds.
Measured: "baseline" and "immediately after end of treatment"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start9 May 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TRCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Rehabilitation Institute
- Responsible party
- Sponsor
- Investigators
- Michael Su, MD, Principal investigator, California Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069999
- Sponsor's protocol ID
- TRC-09
- Status last verified
- Aug 2025
- First submitted
- 27 Sep 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Telerehabilitation Early After CNS Injury
- ClinicalTrials.gov ID
- NCT06069999
- Acronym / sponsor ID
- TRC-09
- Keywords
- Stroke, Traumatic Brain Injuries, Spinal Cord Injuries, Telerehabilitation, Brain Plasticity, Telehealth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TRCare, Inc.Industry (pharma, biotech, devices)
- Collaborators
- California Rehabilitation Institute
- Study start
- 9 May 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 6 Oct 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 goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke, traumatic brain injury (TBI) and/or spinal cord injury (SCI). The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period. Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room. HandyMotion is a sensor-based training system that can connect to the TV set in the hospital room, enabling patients to access their therapy training program to practice rehab-oriented games and exercises ad libitum, at any time of the day.
Detailed description
This clinical trial is designed to address 3 specific aims:
Aim 1: To measure the safety of daily bedside telerehabilitation.
Aim 2: To measure the feasibility of daily bedside telerehabilitation.
Aim 3: To derive a preliminary estimate of motor and functional outcomes in patients engaged in daily bedside telerehabilitation. This is an uncontrolled pilot study, and so it is understood that such measures cannot be attributed to the telerehabilitation intervention, however, these measures will describe the clinical course of a patient engaged in this intervention.
Telerehabilitation therapy is delivered over the course of the inpatient rehabilitation stay. A therapist-facing web portal is used for treatment planning and patient monitoring. The treatment approach was initially designed based on an upper-extremity task-specific training manual and Accelerated Skill Acquisition Program.
Each daily 45-minute treatment session is created by a licensed OT or PT and includes:
- At least 15 min/day of upper extremity exercises. In addition, therapists have the option to incorporate standard exercise equipment (e.g., Theraband or dowels) that can be incorporated into assigned exercises.
- At least 15 min/day of functional training through games. The study provides 2 controllers with 5 different input devices that are available to drive game play. Games stress various motor control features (e.g., varying movement speed, range of motion, target size, extent of visuomotor tracking, or level of cognitive demand), which are selected and adjusted by the therapist.
- If applicable, 5 minutes/day of stroke education. The education content targets five categories (Stroke Risk Factors, Stroke Prevention, Effects of Stroke, Diet, and Exercise) and corresponds to the Stroke Knowledge Exam.
The remaining 10-15 minutes consist of additional exercises and games, per the judgment of the licensed OT or PT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TR Bedside Telerehabilitation | Experimental | Device: HandyMotion Treatment ProgramParticipants will be assigned 45-minutes of therapy training exercises each day for 7 days a week up to 4 weeks or until discharge. Participants will use the HandyMotion device to interact with the telerehabilitation program displayed on the TV set in the patient room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 years or older
- CNS injury with onset in the prior 90 days
- At least one arm must have motor deficits that are neither very mild nor devastating (dense arm plegia). Operationally, this requires that the Visit 1 Box \& Block Test score is at least 1 block, but no more than 30 blocks, in 60 seconds.
- Possess enough arm movement to participate in therapy, including able to hold the HandyMotion device in the paretic hand(s), using an assistive device if needed.
- Informed consent signed by the subject (no surrogate consent permitted for this study)
Key exclusion criteria (6 listed)
- A major, active, coexistent neurological or psychiatric disease that would limit study participation, e.g., advanced dementia or active psychosis
- Expectation that patient's cognitive status will likely interfere substantially with playing assigned games or exercises
- Deficits in communication that interfere with reasonable study participation
- Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
- Subject does not speak sufficient English to comply with study procedures
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 |
|---|---|---|
| HandyMotion Treatment ProgramA pair of sensor-based wireless remote controllers to allow the performance of functional exercises and games that target arm movement. | Device | TR Bedside Telerehabilitation |
Primary outcome
Safety of daily beside telerehabilitation based on incidence of treatment-emergent adverse events as assessed by regular review of the medical record and patient interview
Time frame: "For approximately 4 weeks, up until discharge"
Safety will be measured in terms of adverse events (AEs) deemed related to use of the telerehabilitation system on a probable or definite basis.
2 secondary outcomes
Feasibility of daily bedside telerehabilitation based on measurement of patient compliance, as determined by reviewing electronic records of device usage
Time frame: "baseline" and "immediately after end of treatment"
Box and Blocks Test
Time frame: "baseline" and "immediately after end of treatment"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Cerebral Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Michael Su, MD principal investigator
California Rehabilitation Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HandyMotion Treatment Program in people with Cerebral Stroke and Traumatic Brain Injury, run by TRCare, Inc. at 5 sites 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 10 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety of daily beside telerehabilitation based on incidence of treatment-emergent adverse events as assessed by regular review of the medical record and patient interview (time frame: "For approximately 4 weeks, up until discharge"). 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 29 Aug 2025.