Intensive Upper Extremity Training Program During the Early Subacute Phase After Stroke: A Feasibility 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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: upper extremity training program ("Meditouch","MSQUARE")

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ofakim, Israel
    • Recruiting
    • Aleh Negev Nahalat Eran
    • Contact: Adi Tayer-Yeshurun, MSc; Phone Number: 972-52-3670898

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device-assisted therapy ("Meditouch","MSQUARE"); 40 hours of therapy with the the Hand Tutor (MediTouch) device and a wearable vest (MSQUARE) for arm rehabilitation	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From baseline to day 3 post-training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action research arm test (ARAT)	Change in arm function, measured by. Maximum score (Performs fully) = 57 points Minimum score= 0 points	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	From baseline to day 3 post-training

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Aleh Negev Nahalat Eran, Israel; Ben-Gurion University of the Negev, Israel

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2020
• Primary Completion (Anticipated): November 22, 2022
• Study Completion (Anticipated): November 22, 2022

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 31, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: SHEBA-19-6218-OB-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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