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

NCT ID: NCT06455241

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-02
• Study Completion Date: 2025-12-01

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

HABIT (Hand Activities Behavior Intervention)

Intervention Type: OTHER

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

Interventions

HABIT (Hand Activities Behavior Intervention)

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Debbie Rand

Associate Professor, Researcher at department of occupational therapy, Head of 'Gaming for Rehabilitation' Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Debbie Rand

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Locations

Tel-Aviv University

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Debbie Rand

Role: CONTACT

drand@tauex.tau.ac.il

+972-549490715

Facility Contacts

Debbie Rand

Role: primary

drand@tauex.tau.ac.il

+972-549490715

Other Identifiers

HABIT 0008389-4

Identifier Type: -

Identifier Source: org_study_id