Cerebral StrokeNCT03503617
RehabTouch Home Therapy for Stroke Patients
A study testing RehabTouch and Conventional tabletop exercise program in people with Cerebral Stroke, run by Flint Rehabilitation Devices, LLC at 1 site in United States.
Trial summary
We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cerebral Stroke
- What is being tested?
- RehabTouch and Conventional tabletop exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 85 years old
- Upper extremity weakness measured by a clinical scale
- Absence of moderate to severe pain on affected upper extremity
- Able to understand the instructions to operate RehabTouch
Who cannot join
- Concurrent severe medical problems, visual deficits, severe neglect or apraxia
- Enrollment to other therapy studies
Trial locations and contacts
1 site in 1 country.
United States1 site
Rancho Research Institute, Inc.
Downey, California, 90242
About this study
Official title: RehabTouch: A Mixed-reality Gym for Rehabilitating the Hands, Arms, Trunk, and Legs After Stroke
We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. RehabTouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.
- Conditions
- Cerebral Stroke
- Being tested
- RehabTouch, Conventional tabletop exercise program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabTouchDevice
Also called FitMi
Exercise using the motion sensing devices and a computer
Conventional tabletop exercise programOther
Exercise following printed sheets of exercises
| Study group | Role | What they receive |
|---|---|---|
| RehabTouch Exercise Program | Experimental | Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. Receives: Device: RehabTouch |
| Conventional tabletop exercise program | Active comparator | Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. Receives: Other: Conventional tabletop exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy
The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly.
Measured: From Baseline to One-month Post-therapy
Secondary outcomes (5)
Change in Box and Blocks Test Score
The Box \& Blocks Test (BBT) score assess hand function and gripping ability by instructing an individual to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
Measured: From Baseline to One-month Post-therapy
10 Meter Walk Test
The 10MWT assesses walking speed in meters per second over a short duration.
Measured: From Baseline to One-month Post-therapy
Motor Activity Log
The Motor Activity Log (MAL) is a semi-structured interview to assess arm function after hemiparetic stroke. Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 28 daily functional tasks on a 0-5 point scale. For the QOM subscale, 0 represents an inability to use the affected arm to perform an activity, while 5 represents a normal ability to use the affected arm. For the AOM scale, 0 represents never using the affected arm to perform the activity, and 5 indicates always using the affected arm to perform the activity.
Measured: One-month Post-therapy
Visual Analog Pain Scale
A standard analog scale that ranges from 0 to 10 for assessing pain.
Measured: From Baseline to One-month Post-therapy
Modified Ashworth Spasticity Scale
The Modified Ashworth Spasticity (MAS) Scale measures spasticity in patients with lesions of the Central Nervous System. Tests resistance to passive movement about a joint with varying degrees of velocity, with movements in flexion and extension scored separately. Scores for each movement direction and joint range from 0-5, with 6 choices. A score of 0 indicates no increase in tone during movement. A score of 5 indicates that the limb was rigid during the passive movement.
Measured: From Baseline to One-month Post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 Nov 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flint Rehabilitation Devices, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rancho Research Institute, Inc.
- Responsible party
- Principal investigator, Flint Rehabilitation Devices, LLC, Flint Rehabilitation Devices, LLC
- Investigators
- Susan Shaw, MD, Principal investigator, Rancho Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503617
- Sponsor's protocol ID
- 1R44AG059256-01A1
- Status last verified
- Jan 2022
- First submitted
- 11 Apr 2018
- Last updated
- 7 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Swanson VA, Johnson C, Zondervan DK, Bayus N, McCoy P, Ng YFJ, Schindele Bs J, Reinkensmeyer DJ, Shaw S. Optimized Home Rehabilitation Technology Reduces Upper Extremity Impairment Compared to a Conventional Home Exercise Program: A Randomized, Controlled, Single-Blind Trial in Subacute Stroke. Neurorehabil Neural Repair. 2023 Jan;37(1):53-65. doi: 10.1177/15459683221146995. Epub 2023 Jan 12.
PubMed 36636751
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RehabTouch: A Mixed-reality Gym for Rehabilitating the Hands, Arms, Trunk, and Legs After Stroke
- ClinicalTrials.gov ID
- NCT03503617
- Acronym / sponsor ID
- 1R44AG059256-01A1
- Conditions
- Cerebral Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Flint Rehabilitation Devices, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Rancho Research Institute, Inc.
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Posted 7 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. RehabTouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RehabTouch Exercise Program | Experimental | Device: RehabTouchParticipants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. |
| Conventional tabletop exercise program | Active comparator | Other: Conventional tabletop exercise programConventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 to 85 years old
- Upper extremity weakness measured by a clinical scale
- Absence of moderate to severe pain on affected upper extremity
- Able to understand the instructions to operate RehabTouch
Key exclusion criteria (2 listed)
- Concurrent severe medical problems, visual deficits, severe neglect or apraxia
- Enrollment to other therapy studies
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 |
|---|---|---|
| RehabTouchAlso: FitMiExercise using the motion sensing devices and a computer | Device | RehabTouch Exercise Program |
| Conventional tabletop exercise programExercise following printed sheets of exercises | Other | Conventional tabletop exercise program |
Primary outcome
Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy
Time frame: From Baseline to One-month Post-therapy
The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly.
5 secondary outcomes
Change in Box and Blocks Test Score
Time frame: From Baseline to One-month Post-therapy
10 Meter Walk Test
Time frame: From Baseline to One-month Post-therapy
Motor Activity Log
Time frame: One-month Post-therapy
Visual Analog Pain Scale
Time frame: From Baseline to One-month Post-therapy
Modified Ashworth Spasticity Scale
Time frame: From Baseline to One-month Post-therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36636751Swanson VA, Johnson C, Zondervan DK, Bayus N, McCoy P, Ng YFJ, Schindele Bs J, Reinkensmeyer DJ, Shaw S. Optimized Home Rehabilitation Technology Reduces Upper Extremity Impairment Compared to a Conventional Home Exercise Program: A Randomized, Controlled, Single-Blind Trial in Subacute Stroke. Neurorehabil Neural Repair. 2023 Jan;37(1):53-65. doi: 10.1177/15459683221146995. Epub 2023 Jan 12.
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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.
Susan Shaw, MD principal investigator
Rancho Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RehabTouch and Conventional tabletop exercise program in people with Cerebral Stroke, run by Flint Rehabilitation Devices, LLC 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 4 inclusion and 2 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 7 Feb 2022. 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?
Yes. Results are posted in the registry (first posted 7 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy (time frame: From Baseline to One-month Post-therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03503617, which also lists 1 linked publication.
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 7 Feb 2022.