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

NCT04737395 | Unknown

• 1 other identifier: SHEBA-19-6218-OB-CTIL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Action research arm test (ARAT)

  From baseline to day 3 post-training

• Stroke Impact Scale (SIS)

  From baseline to day 3 post-training

Study Arms (1)

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

Device: upper extremity training program ("Meditouch","MSQUARE")

Interventions

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

Device-assisted therapy ("Meditouch","MSQUARE")

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead
• Aleh Negev Nahalat Eran, Israel: collaborator
• Ben-Gurion University of the Negev, Israel: collaborator

Study Sites (1)

Aleh Negev Nahalat Eran

Ofakim, Israel

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Adi Tayer-Yeshurun, MSc, BPt

CONTACT

0523670898; adiyes@gmail.com

Noy Goldhamer, BSc

CONTACT

0509663335; noygold@post.bgu.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Orthopedic Rehabilitation Department

Model Details: Single arm

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 3, 2021
• Study Start: November 22, 2020
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)