Intensive Upper Extremity Training Program During the Early Subacute Phase After Stroke: A Feasibility Study
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
upper extremity training program ("Meditouch","MSQUARE")
Sponsored by

About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Sites / Locations
- Aleh Negev Nahalat EranRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device-assisted therapy ("Meditouch","MSQUARE")
Arm Description
40 hours of therapy with the the Hand Tutor (MediTouch) device and a wearable vest (MSQUARE) for arm rehabilitation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Action research arm test (ARAT)
Change in arm function, measured by. Maximum score (Performs fully) = 57 points Minimum score= 0 points
Stroke Impact Scale (SIS)
Change in disability and health related quality of life Maximum score (Performs fully) = 25 points Minimum score= 0 points
Full Information
NCT ID
NCT04737395
First Posted
January 19, 2021
Last Updated
January 31, 2021
Sponsor
Sheba Medical Center
Collaborators
Aleh Negev Nahalat Eran, Israel, Ben-Gurion University of the Negev, Israel
1. Study Identification
Unique Protocol Identification Number
NCT04737395
Brief Title
Intensive Upper Extremity Training Program During the Early Subacute Phase After Stroke: A Feasibility Study
Official Title
Intensive Upper Extremity Training Program During the Early Subacute Phase After Stroke: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 22, 2020 (Actual)
Primary Completion Date
November 22, 2022 (Anticipated)
Study Completion Date
November 22, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Aleh Negev Nahalat Eran, Israel, Ben-Gurion University of the Negev, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Device-assisted therapy ("Meditouch","MSQUARE")
Arm Type
Experimental
Arm Description
40 hours of therapy with the the Hand Tutor (MediTouch) device and a wearable vest (MSQUARE) for arm rehabilitation
Intervention Type
Device
Intervention Name(s)
upper extremity training program ("Meditouch","MSQUARE")
Intervention Description
40 hours of therapy with the Hand Tutor (MediTouch) device and a wearable vest (EkssoUE, Ekso Bionics) for arm rehabilitation
Primary Outcome Measure Information:
Title
Fugl-Meyer upper extremity assessment (FM-UE)
Description
Change in arm impairment, measured by FM-UE. Maximum score (Performs fully) =226 points Minimum score= 0 points
Time Frame
From baseline to day 3 post-training
Secondary Outcome Measure Information:
Title
Action research arm test (ARAT)
Description
Change in arm function, measured by. Maximum score (Performs fully) = 57 points Minimum score= 0 points
Time Frame
From baseline to day 3 post-training
Title
Stroke Impact Scale (SIS)
Description
Change in disability and health related quality of life Maximum score (Performs fully) = 25 points Minimum score= 0 points
Time Frame
From baseline to day 3 post-training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adi Tayer-Yeshurun, MSc, BPt
Phone
0523670898
Email
adiyes@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Noy Goldhamer, BSc
Phone
0509663335
Email
noygold@post.bgu.il
Facility Information:
Facility Name
Aleh Negev Nahalat Eran
City
Ofakim
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adi Tayer-Yeshurun, MSc
Phone
972-52-3670898
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intensive Upper Extremity Training Program During the Early Subacute Phase After Stroke: A Feasibility Study
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