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

Stroke Clinical Trial

— HABIT  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455241
• Other study ID #: HABIT 0008389-4
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2024
• Source: Tel Aviv University
• Contact: Debbie Rand
• Phone: +972-549490715
• Email: drand[@]tauex.tau.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 three time points: baseline, pre and post the HABIT intervention.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic and stroke information questionnaire	to describe the participants	baseline (week 0)
Other	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)
Other	Instrumental Activities of Living (IADL) questionnaire	to assess independence in IADL	baseline (week 0)
Other	Thumb localizing 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)
Primary	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)
Primary	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)
Secondary	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)
Secondary	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)
Secondary	Satisfaction from the HABIT intervention	A self-report questionnaire assessing the satisfaction with the novel intervention	post intervention (week 8)
Secondary	Change in daily hand-use as assessed by Ecological Momentary Assessment (EMA)	Ecological Momentary Assessment (EMA) will be conducted 2-3 times a day for 2-4 days . Participants will be asked via text or phone what activity they are doing (self-care, indoor or outdoor chores, leisure) and if they are using their affected hand. Then participants will need to assess how they are using their hand (1-5 on the quality scale of the Motor Activity Log), how satisfied they are (0-100%) with the use of their hand & to rate the confidence when using their hand.	no change from pre intervention (3 week) but change from pre to post intervention (8 week)