StrokeNCT04737395
Intensive Upper Extremity Training Program During the Early Subacute Phase After Stroke: A Feasibility Study
A study testing upper extremity training program ("Meditouch","MSQUARE") in people with Stroke, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The study assesses the feasibility of a 4-week upper extremity training program emphasizing quality of movement practiced at high intensity and dosage applied during the early subacute phase after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- upper extremity training program ("Meditouch","MSQUARE")
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Nov 2020to 22 Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years;
- Ischemic or hemorrhagic stroke (hemispheric or brainstem) confirmed by CT or MRI;
- First-ever stroke or previous stroke with no upper extremity weakness;
- 1 week ≤ Time after stroke onset ≤ 6 weeks;
- Active shoulder flexion of at least 20◦ and partial wrist and/or finger active movement;
- Ability to provide inform consent.
Who cannot join
- A painful shoulder limiting an active forward reach;
- Severe spasticity or non-neural loss of range of motion;
- Cognitive or communication impairments as determined by the clinical team;
- Unstable medical conditions.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Aleh Negev Nahalat Eran
Ofakim
Adi Tayer-Yeshurun, MSc, 972-52-3670898
About this study
The study assesses the feasibility of a 4-week upper extremity training program emphasizing quality of movement practiced at high intensity and dosage applied during the early subacute phase after stroke.
Read the detailed description
Participants will receive 120 minutes of upper extremity training X 5 days per week for 4 weeks in addition to their daily rehabilitative routine (total therapy time 40 hours in addition to daily routine treatments of approximately 60 hours). Each session will be staffed with a 1:1 PT/OT to patient ratio.
The aim of the program is to increase the time spent on tasks using customized game-based platforms that include highly immersive, challenging and rewarding virtual environments for upper limb training. The focus of these game-based platforms is to reduce upper extremity impairments through emphasizing the quality of movement execution.
In one platform, the participant controls virtual dolphin movements by moving his/her paretic upper limb. The game utilizes advanced artificial intelligence (AI) analysis of the video recordings in real-time. In case the participant needs arm weight support, the practice will perform the task with a mechanical wearable exoskeleton vest, EkssoUE (Ekso Bionics) that can provide support at different weight levels. Arm weight support will be titrated as the patient progresses through each session and will be reduced/removed if no significant compensatory strategies were used.
The second platform, the HandTutor system (MediTouch) consists of an ergonomic wearable glove and a dedicated software with games that allow practicing active wrist movements, grip control and finger individuation in a challenging and motivating environment. Participant progresses through simple to difficult games while adjusting the range of motion that is being practiced according to participant's abilities.
Training in both platforms will be conducted in sitting. Participant will continue with their regular rehabilitative routine that includes daily physical and occupational therapy sessions and speech therapy if needed as well as group work and gym.
To assess the feasibility of the proposed intervention the following data/measures will be documented:
Adherence rates; Time on task (in minutes); Progression in game levels and the amount of weight support; Attendance to routine rehabilitative sessions; Visual Analogue Scale will be used to monitor the levels of pain; Rating perceived exertion (RPE), the revised category-ratio scale (0 to 10 scale) will be used to monitor and guide exercise intensity; The Pittsburgh rehabilitation participation scale (PRPS); The Intrinsic Motivation Inventory (IMI) - will be assessed at the end of intervention period; Acceptability and satisfaction of the intervention to participants will be assessed at the end of training period using a self-designed questionnaire/rating scale; Adverse events; Problems/difficulties related to intervention equipment (software, hardware, vest etc.).
To evaluate the potential effectiveness of the intervention the following data/measures will be conducted at baseline (prior training), immediately post intervention and at 12 (±14) and 24 (±14) weeks post stroke:
Fugl-Meyer upper extremity assessment (FM-UE); Action research arm test (ARAT); Stroke Impact Scale (SIS) hand domain, version 2.0; Upper extremity impairment and function will be assessed using a reaching and a grasping tasks that will be recorded using multiple high resolution video-cameras and analyzed using AI algorithm (OpenPose).
- Conditions
- Stroke
- Being tested
- upper extremity training program ("Meditouch","MSQUARE")
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper extremity training program ("Meditouch","MSQUARE")Device
40 hours of therapy with the Hand Tutor (MediTouch) device and a wearable vest (EkssoUE, Ekso Bionics) for arm rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Device-assisted therapy ("Meditouch","MSQUARE") | Experimental | 40 hours of therapy with the the Hand Tutor (MediTouch) device and a wearable vest (MSQUARE) for arm rehabilitation Receives: Device: upper extremity training program ("Meditouch","MSQUARE") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer upper extremity assessment (FM-UE)
Change in arm impairment, measured by FM-UE. Maximum score (Performs fully) =226 points Minimum score= 0 points
Measured: From baseline to day 3 post-training
Secondary outcomes (2)
Action research arm test (ARAT)
Change in arm function, measured by. Maximum score (Performs fully) = 57 points Minimum score= 0 points
Measured: From baseline to day 3 post-training
Stroke Impact Scale (SIS)
Change in disability and health related quality of life Maximum score (Performs fully) = 25 points Minimum score= 0 points
Measured: From baseline to day 3 post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start22 Nov 2020
- Primary completion22 Nov 2022 (estimated)
- Study completion22 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Aleh Negev Nahalat Eran, Israel, Ben-Gurion University of the Negev, Israel
- Responsible party
- Principal investigator, Dr. Oren Barzel, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737395
- Sponsor's protocol ID
- SHEBA-19-6218-OB-CTIL
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Upper Extremity Training Program During the Early Subacute Phase After Stroke: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04737395
- Acronym / sponsor ID
- SHEBA-19-6218-OB-CTIL
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Aleh Negev Nahalat Eran, Israel, Ben-Gurion University of the Negev, Israel
- Study start
- 22 Nov 2020 (actual)
- Primary completion
- 22 Nov 2022 (estimated)
- Study completion
- 22 Nov 2022 (estimated)
- First posted
- 3 Feb 2021 (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 assesses the feasibility of a 4-week upper extremity training program emphasizing quality of movement practiced at high intensity and dosage applied during the early subacute phase after stroke.
Detailed description
Participants will receive 120 minutes of upper extremity training X 5 days per week for 4 weeks in addition to their daily rehabilitative routine (total therapy time 40 hours in addition to daily routine treatments of approximately 60 hours). Each session will be staffed with a 1:1 PT/OT to patient ratio.
The aim of the program is to increase the time spent on tasks using customized game-based platforms that include highly immersive, challenging and rewarding virtual environments for upper limb training. The focus of these game-based platforms is to reduce upper extremity impairments through emphasizing the quality of movement execution.
In one platform, the participant controls virtual dolphin movements by moving his/her paretic upper limb. The game utilizes advanced artificial intelligence (AI) analysis of the video recordings in real-time. In case the participant needs arm weight support, the practice will perform the task with a mechanical wearable exoskeleton vest, EkssoUE (Ekso Bionics) that can provide support at different weight levels. Arm weight support will be titrated as the patient progresses through each session and will be reduced/removed if no significant compensatory strategies were used.
The second platform, the HandTutor system (MediTouch) consists of an ergonomic wearable glove and a dedicated software with games that allow practicing active wrist movements, grip control and finger individuation in a challenging and motivating environment. Participant progresses through simple to difficult games while adjusting the range of motion that is being practiced according to participant's abilities.
Training in both platforms will be conducted in sitting. Participant will continue with their regular rehabilitative routine that includes daily physical and occupational therapy sessions and speech therapy if needed as well as group work and gym.
To assess the feasibility of the proposed intervention the following data/measures will be documented:
Adherence rates; Time on task (in minutes); Progression in game levels and the amount of weight support; Attendance to routine rehabilitative sessions; Visual Analogue Scale will be used to monitor the levels of pain; Rating perceived exertion (RPE), the revised category-ratio scale (0 to 10 scale) will be used to monitor and guide exercise intensity; The Pittsburgh rehabilitation participation scale (PRPS); The Intrinsic Motivation Inventory (IMI) - will be assessed at the end of intervention period; Acceptability and satisfaction of the intervention to participants will be assessed at the end of training period using a self-designed questionnaire/rating scale; Adverse events; Problems/difficulties related to intervention equipment (software, hardware, vest etc.).
To evaluate the potential effectiveness of the intervention the following data/measures will be conducted at baseline (prior training), immediately post intervention and at 12 (±14) and 24 (±14) weeks post stroke:
Fugl-Meyer upper extremity assessment (FM-UE); Action research arm test (ARAT); Stroke Impact Scale (SIS) hand domain, version 2.0; Upper extremity impairment and function will be assessed using a reaching and a grasping tasks that will be recorded using multiple high resolution video-cameras and analyzed using AI algorithm (OpenPose).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm
| Arm | Type | Receives |
|---|---|---|
| Device-assisted therapy ("Meditouch","MSQUARE") | Experimental | Device: upper extremity training program ("Meditouch","MSQUARE")40 hours of therapy with the the Hand Tutor (MediTouch) device and a wearable vest (MSQUARE) for arm rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥18 years;
- Ischemic or hemorrhagic stroke (hemispheric or brainstem) confirmed by CT or MRI;
- First-ever stroke or previous stroke with no upper extremity weakness;
- 1 week ≤ Time after stroke onset ≤ 6 weeks;
- Active shoulder flexion of at least 20◦ and partial wrist and/or finger active movement;
Key exclusion criteria (4 listed)
- A painful shoulder limiting an active forward reach;
- Severe spasticity or non-neural loss of range of motion;
- Cognitive or communication impairments as determined by the clinical team;
- Unstable medical conditions.
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 |
|---|---|---|
| upper extremity training program ("Meditouch","MSQUARE")40 hours of therapy with the Hand Tutor (MediTouch) device and a wearable vest (EkssoUE, Ekso Bionics) for arm rehabilitation | Device | Device-assisted therapy ("Meditouch","MSQUARE") |
Primary outcome
Fugl-Meyer upper extremity assessment (FM-UE)
Time frame: From baseline to day 3 post-training
Change in arm impairment, measured by FM-UE. Maximum score (Performs fully) =226 points Minimum score= 0 points
2 secondary outcomes
Action research arm test (ARAT)
Time frame: From baseline to day 3 post-training
Stroke Impact Scale (SIS)
Time frame: From baseline to day 3 post-training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upper extremity training program ("Meditouch","MSQUARE") in people with Stroke, run by Sheba Medical Center at 1 site in Israel.
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 6 inclusion and 4 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 3 Feb 2021. 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 Israel. 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 Adi Tayer-Yeshurun, MSc, BPt (0523670898, adiyes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer upper extremity assessment (FM-UE) (time frame: From baseline to day 3 post-training). 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 3 Feb 2021.