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

Feasibility and Efficacy of HABIT - a Novel Occupational Therapy Intervention for Enhancing Daily-Use of the Affected Upper Extremity Among Individuals Post Stroke.

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) .

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: HABIT (Hand Activities Behavior Intervention)

Detailed Description

The goal of this study is to test the feasibility and efficacy of HABIT (Hand Activities Behavior Intervention) in increasing daily hand-use of the affected upper extremity among individuals with good motor ability post-stroke.

The aim of HABIT is to increase the daily use of the weaker hand in everyday activities by improving non-motor components (such as self-efficacy, raising the frustration threshold for performing tasks with the affected upper extremity, and creating opportunities for hand use). HABIT will include group discussions, analysis of challenges in using the affected upper extremity, home exercises, problem-solving and practice and dual-task activities. The intervention will focus on raising awareness, changing habits, and practicing the use of the affected upper extremity.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Debbie Rand; Phone Number: +972-549490715; Email: drand@tauex.tau.ac.il

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Tel-Aviv University
    • Contact: Debbie Rand; Phone Number: +972-549490715; Email: drand@tauex.tau.ac.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Upper-Extremity-Cognitive Dual Task capacity	The dual-task will include the Box and Block test (number of blocks transferred in one minute) and the counting backward task in increments of 3 from a three-digit number (number of correct answers in one minute).	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)	This is a 20-item questionnaire assess the self-efficacy to use the affected hand after stroke in social, household, and community contexts.	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	A self-report questionnaire assessing the satisfaction with the novel intervention	post intervention (week 8) and at follow-up (3-6 months by phone)
Change in Upper-extremity Motor Activity Log (UE-MAL)	This instrument is a structured interview intended to examine how much and how well the subject uses their more-affected arm outside of the laboratory setting. Participants are asked standardized questions about the amount of use of their more-affected arm (Amount Scale or AS) and the quality of their movement (How Well Scale or HW) during the functional activities indicated. The scales are printed on separate sheets of paper and are placed in front of the participant during test administration. participants should be told that they can give half scores (i.e., 0.5,1.5,2.5,3.5,4.5) if this is reflective of their ratings. 0-not used to 5- same as pre-stroke/ normal.	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	U-Rate-UE includes the following single self-perceived question: "please rate how much your affected UE has recovered from your stroke ". Participants were presented with a 10- point vertical scale starting at the bottom from 0 (no recovery) to 100 (full recovery) at the top of the scale but could rate any whole number from 0 to 100. Participants were asked to rate this question verbally or by pointing on the scale to estimate the extent to which the affected UE has recovered from the stroke as a percentage of its full(pre stroke) ability.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic and stroke information questionnaire	to describe the participants	baseline (week 0)
Functional Independence Measure	The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations. It includes 18-items of basic activities. Each item in rated from 1 (not independent) to 7 (independent) points. The total score for the FIM instrument will be a value between 18 and 126.	baseline (week 0)
Instrumental Activities of Living (IADL) questionnaire	to assess independence in IADL	baseline (week 0) and at follow-up (3-6 months)
Thumb localization test TLT	This is a standard assessment for evaluating proprioceptive sensation in individuals after a stroke. With the participant's eyes closed, the examiner moves the affected hand into four different positions. The participant is then required to grasp the thumb of the affected hand with their strong hand. The ability to grasp the thumb in each of the positions is rated from 0 (normal) to 3 (significant sensory impairment). The final score of the assessment is the lowest score among the four positions.	baseline (week 0)

Collaborators and Investigators

• Sponsor: Tel Aviv University
• Investigators: Principal Investigator: Debbie Rand, Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 1, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Behavior; Self-efficacy; Group intervention; Daily Hand-use
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: HABIT 0008389-4

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.: No