Cerebral StrokeNCT05625438
Telerehabilitation Early After Stroke
A study testing HandyMotion Treatment Program in people with Cerebral Stroke, run by TRCare, Inc. at 1 site 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. The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Stroke
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2022to Dec 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
- Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage, and with time of stroke onset <30 days prior to enrollment; or traumatic brain injury.
- Unilateral arm motor deficits that are neither trivial (no arm weakness) or devastating (arm plegia). This requires that the baseline Box \& Block Test score with affected arm to be at least 1 block in 60 seconds but no more than 90% of the number of blocks with the good arm.
- Possess enough arm movement to participate in therapy
- Informed consent signed by the subject
- 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
- 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 telerehabilitation therapy completed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Providence St. Jude Medical Center
Fullerton, California, 92835
Natalia Covarrubias-Eckardt, MD, 714-992-3000 ext. 1600, Natalia.Covarrubias-Eckardt@stjoe.org
Natalia Covarrubias-Eckardt, MD
About this study
Official title: Bedside Telerehabilitation Early After Stroke
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. 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.
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.
- Five 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.
- Conditions
- Cerebral Stroke
- Being tested
- HandyMotion Treatment Program
- Medical subject headings
- Stroke
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 |
|---|---|---|
| Bedside Telerehabilitation | Experimental | Participants will be assigned 45-minute therapy training exercises each day for 5 days per week.
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 2 weeks, up until 2 days prior to 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.
Measured: "baseline" and "immediately after end of treatment"
Box and Blocks Test
Measure of Upper Extremity Function by assessing unilateral gross manual dexterity. Participant 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 posted23 Nov 2022
- Study start19 Dec 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TRCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Providence St. Jude Medical Center
- Responsible party
- Sponsor
- Investigators
- Natalia Covarrubias-Eckardt, MD, Principal investigator, Providence St. Jude Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625438
- Sponsor's protocol ID
- TRC-08
- Status last verified
- Dec 2024
- First submitted
- 1 Nov 2022
- Last updated
- 6 Dec 2024
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Telerehabilitation Early After Stroke
- ClinicalTrials.gov ID
- NCT05625438
- Acronym / sponsor ID
- TRC-08
- Conditions
- Cerebral Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TRCare, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Providence St. Jude Medical Center
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Nov 2022 (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. 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.
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.
- Five 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bedside Telerehabilitation | Experimental | Device: HandyMotion Treatment ProgramParticipants will be assigned 45-minute therapy training exercises each day for 5 days per week. 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 (7 listed)
- Age 18 years or older
- Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage, and with time of stroke onset <30 days prior to enrollment; or traumatic brain injury.
- Unilateral arm motor deficits that are neither trivial (no arm weakness) or devastating (arm plegia). This requires that the baseline Box \& Block Test score with affected arm to be at least 1 block in 60 seconds but no more than 90% of the number of blocks with the good arm.
- Possess enough arm movement to participate in therapy
- Informed consent signed by the subject
Key exclusion criteria (6 listed)
- A major, active, coexistent neurological or psychiatric disease that would limit study participation, e.g., advanced dementia
- 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 | 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 2 weeks, up until 2 days prior to 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 6 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Natalia Covarrubias-Eckardt, MD principal investigator
Providence St. Jude Medical Center
1 site 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, run by TRCare, Inc. 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 7 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: looking for participants now, as of the sponsor's last update on 6 Dec 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?
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?
Contact Johnson K Sun (650-300-2168, kit@trcare.net), or a site near the patient. 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 2 weeks, up until 2 days prior to 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 6 Dec 2024.