Feasibility and Efficacy of HABIT for Enhancing Daily Hand-Use Post Stroke

NCT06455241 | Recruiting

• 1 other identifier: HABIT 0008389-4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This experimental design will assess the feasibility \& initial effectiveness of HABIT - a novel occupational therapy to increase the daily hand-use of the affected upper extremity post stroke. Assessments will be conducted at four time points: baseline, pre, post the HABIT intervention and follow-up (by phone) .

Conditions

Stroke

Keywords

Self-efficacy; Behavior; Stroke; Group intervention; Daily Hand-use

Outcome Measures

Primary Outcomes (2)

• Change in scores of the Rating of Everyday Arm-Use in the Community and Home (REACH)

  A short questionnaire assessing the level of daily use of the affected hand after stroke in daily activities. The questionnaire consists of 2-5 questions (depending on the responses being assessed), from which a score is obtained determining the level of use of the affected hand. The score ranges from 0 (no use of the affected hand) to 5 (full use).

  no change from baseline (0 week) to pre intervention (3 week) but change from pre to post intervention (8 week) and change from post to follow-up (3-6 months)

• Change in scores of the Canadian Occupational Performance Measure (COPM)

  Change in scores of performance and satisfaction of performance for therapeutic goals that the participants define as important to them. Goals will focus on using the affected upper extremity.

  no change from baseline (0 week) to pre intervention (3 week) but change from pre to post intervention (8 week) and change from post to follow-up (3-6 months)

Secondary Outcomes (5)

• Change in Upper-Extremity-Cognitive Dual Task capacity

  no change from baseline (0 week) to pre intervention (3 week) but change from pre to post intervention (8 week)

• Change in Confidence in Arm and Hand Movement scale (CAHM)

  no change from baseline (0 week) to pre intervention (3 week) but change from pre to post intervention (8 week) and change from post to follow-up (3-6 months)

• Satisfaction from the HABIT intervention

  post intervention (week 8) and at follow-up (3-6 months by phone)

• Change in Upper-extremity Motor Activity Log (UE-MAL)

  no change from baseline (0 week) to pre intervention (3 week) but change from pre to post intervention (8 week) and change from post to follow-up (3-6 months)

• Change in U-rate UE

  no change from baseline (0 week) to pre intervention (3 week) but change from pre to post intervention (8 week) and change from post to follow-up (3-6 months)

Other Outcomes (4)

• Demographic and stroke information questionnaire

  baseline (week 0)

• Functional Independence Measure

  baseline (week 0)

• Instrumental Activities of Living (IADL) questionnaire

  baseline (week 0) and at follow-up (3-6 months)

Study Arms (1)

HABIT

EXPERIMENTAL

All participants will receive HABIT - a novel occupational therapy intervention. HABIT will include 10 sessions (2 sessions per week for 5 weeks). HABIT will include small group of 5-8 participants, so approximately 4 rounds of HABIT will be needed to reach 20 participants

Other: HABIT (Hand Activities Behavior Intervention)

Interventions

HABIT (Hand Activities Behavior Intervention) OTHER

A Novel Occupational Therapy Intervention for Enhancing Daily Hand-Use of the affected upper extremity Among Individuals post Stroke.

HABIT

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 and above residing in their own homes
• Hebrew speakers
• Up to 10 years post-stroke
• Mild upper extremity motor impairment but still report difficulty using their hand. This will be determined by a total score of 43/66, including the Hand subtest score of 7/14 points of the Fugl-Meyer Motor Assessment.
• No significant cognitive decline (score of 19 and above on Montreal Cognitive Assessment)
• Able to walk with or without assistive devices
• Able to provide informed consent by signing a consent form
• Full function of both hands and independent in daily function prior to stroke

You may not qualify if:

• Other neurological conditions or psychiatrists
• with moderate or significant proprioception deficit (Thumb Localization Test \>1)

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel-Aviv University

Tel Aviv, Israel

RECRUITING

Related Publications (1)

• Bachar Kirshenboim Y, Levy A, Rand D. The hand activity and behavior intervention (HABIT): a novel group to increase daily hand-use post-stroke. Disabil Rehabil. 2026 Jan 4:1-14. doi: 10.1080/09638288.2025.2609762. Online ahead of print.

  PMID: 41485200 DERIVED

MeSH Terms

Conditions

Stroke; Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Debbie Rand

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debbie Rand

CONTACT

+972-549490715; drand@tauex.tau.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Researcher at department of occupational therapy, Head of 'Gaming for Rehabilitation' Lab

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 12, 2024
• Study Start: June 2, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)