StrokeHABITNCT06455241
Feasibility and Efficacy of HABIT for Enhancing Daily Hand-Use Post Stroke
A study testing HABIT (Hand Activities Behavior Intervention) in people with Stroke, run by Tel Aviv University at 1 site in Israel.
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 four time points: baseline, pre, post the HABIT intervention and follow-up (by phone) . Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke
- What is being tested?
- HABIT (Hand Activities Behavior Intervention)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Jun 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other neurological conditions or psychiatrists
- with moderate or significant proprioception deficit (Thumb Localization Test >1)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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) .
Read the 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
- Being tested
- HABIT (Hand Activities Behavior Intervention)
- Keywords
- Self-efficacy, Behavior, Stroke, Group intervention, Daily Hand-use
- Medical subject headings
- Stroke, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HABIT (Hand Activities Behavior Intervention)Other
A Novel Occupational Therapy Intervention for Enhancing Daily Hand-Use of the affected upper extremity Among Individuals post Stroke.
| Study group | Role | What they receive |
|---|---|---|
| HABIT | Experimental | 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 Receives: Other: HABIT (Hand Activities Behavior Intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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 (5)
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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start2 Jun 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Debbie Rand, Tel Aviv University
- Investigators
- Debbie Rand, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455241
- Sponsor's protocol ID
- HABIT 0008389-4
- Acronym
- HABIT
- Status last verified
- Jul 2024
- First submitted
- 1 Jun 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bachar Kirshenboim Y, Levy A, Rand D. The hand activity and behavior intervention (HABIT): a novel group to increase daily hand-use post-stroke. Disabil Rehabil. 2026 Jul;48(15):4781-4794. doi: 10.1080/09638288.2025.2609762. Epub 2026 Jan 4.
PubMed 41485200
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06455241
- Acronym / sponsor ID
- HABIT / HABIT 0008389-4
- Conditions
- Stroke
- Keywords
- Self-efficacy, Behavior, Stroke, Group intervention, Daily Hand-use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 2 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HABIT | Experimental | Other: HABIT (Hand Activities Behavior Intervention)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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (2 listed)
- Other neurological conditions or psychiatrists
- with moderate or significant proprioception deficit (Thumb Localization Test >1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HABIT (Hand Activities Behavior Intervention)A Novel Occupational Therapy Intervention for Enhancing Daily Hand-Use of the affected upper extremity Among Individuals post Stroke. | Other | HABIT |
Primary outcome
Change in scores of the Rating of Everyday Arm-Use in the Community and Home (REACH)
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Change in Upper-Extremity-Cognitive Dual Task capacity
Time frame: 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)
Time frame: 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
Time frame: post intervention (week 8) and at follow-up (3-6 months by phone)
Change in Upper-extremity Motor Activity Log (UE-MAL)
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Derived from this study: PubMed 41485200Bachar Kirshenboim Y, Levy A, Rand D. The hand activity and behavior intervention (HABIT): a novel group to increase daily hand-use post-stroke. Disabil Rehabil. 2026 Jul;48(15):4781-4794. doi: 10.1080/09638288.2025.2609762. Epub 2026 Jan 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debbie Rand principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HABIT (Hand Activities Behavior Intervention) in people with Stroke, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores of the Rating of Everyday Arm-Use in the Community and Home (REACH) (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06455241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.