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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06455241
Acronym
HABIT
Enrollment
11
Registered
2024-06-12
Start date
2024-06-02
Completion date
2025-12-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

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

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) .

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.

Interventions

OTHERHABIT (Hand Activities Behavior Intervention)

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

Sponsors

Tel Aviv University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in scores of the Rating of Everyday Arm-Use in the Community and Home (REACH)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)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).
Change in scores of the Canadian Occupational Performance Measure (COPM)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 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.

Secondary

MeasureTime frameDescription
Change in Upper-Extremity-Cognitive Dual Task capacityno change from baseline (0 week) to pre intervention (3 week) but change from pre to post intervention (8 week)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).
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)This is a 20-item questionnaire assess the self-efficacy to use the affected hand after stroke in social, household, and community contexts.
Satisfaction from the HABIT interventionpost intervention (week 8) and at follow-up (3-6 months by phone)A self-report questionnaire assessing the satisfaction with the novel intervention
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)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.
Change in U-rate UEno 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)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.

Countries

Israel

Contacts

PRINCIPAL_INVESTIGATORDebbie Rand

Tel Aviv University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026