Clinical trial NCT06455241: Feasibility and Efficacy of HABIT for Enhancing Daily Hand-Use Post Stroke
Official title: Feasibility and Efficacy of HABIT - a Novel Occupational Therapy Intervention for Enhancing Daily-Use of the Affected Upper Extremity Among Individuals Post Stroke.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Self-efficacy
Behavior
Stroke
Group intervention
Daily Hand-use
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in scores of the Rating of Everyday Arm-Use in the Community and Home (REACH)
timeFrame: 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)
measure: Change in scores of the Canadian Occupational Performance Measure (COPM)
timeFrame: 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:
measure: Change in Upper-Extremity-Cognitive Dual Task capacity
timeFrame: no change from baseline (0 week) to pre intervention (3 week) but change from pre to post intervention (8 week)
measure: Change in Confidence in Arm and Hand Movement scale (CAHM)
timeFrame: 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)
measure: Satisfaction from the HABIT intervention
timeFrame: post intervention (week 8) and at follow-up (3-6 months by phone)
measure: Change in Upper-extremity Motor Activity Log (UE-MAL)
timeFrame: 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)
measure: Change in U-rate UE
timeFrame: 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:
measure: Demographic and stroke information questionnaire
timeFrame: baseline (week 0)
measure: Functional Independence Measure
timeFrame: baseline (week 0)
measure: Instrumental Activities of Living (IADL) questionnaire
timeFrame: baseline (week 0) and at follow-up (3-6 months)
measure: Thumb localization test TLT
timeFrame: baseline (week 0)
Locations:
city: Tel Aviv
country: Israel
facility: Tel-Aviv University
Study officials:
affiliation: Tel Aviv University
name: Debbie Rand
role: PRINCIPAL_INVESTIGATOR
References: