StrokeNCT02925637
Effectiveness of FACoT for Individuals Post Stroke
A study testing FaCoT in people with Stroke, run by Bait Balev Hospital at 1 site in Israel.
Trial summary
To develop and assess the effectiveness of a novel cognitive-functional intervention (FACoT) in occupational therapy for people after mild to moderate stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- FaCoT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Mar 2017to 27 Feb 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years
- at least three years post stroke
- severity mild to moderate (NIHSS≤5)
- independent prior to the stroke
- can understand and speak Hebrew
Who cannot join
- with no other neurological or psychiatric conditions
- without dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Novel Meta-cognitive-functional Intervention (FACoT) for Individuals Post Mild-moderate Stroke
To develop and assess the effectiveness of a novel cognitive-functional intervention (FACoT) in occupational therapy for people after mild to moderate stroke.
- Conditions
- Stroke
- Being tested
- FaCoT
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FaCoTOther
The intervention will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies
| Study group | Role | What they receive |
|---|---|---|
| FACoT group | Experimental | treatment group will receive FACoT, that include one to one 10 treatment sessions. the treatment sessions will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies Receives: Other: FaCoT |
| control group | No intervention | control group receiving standard care - cognitive and functional assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores of The Canadian Occupational Performance Measure (COPM)
Measured: Change between baseline (week 0) to time 1 (post-intervention -10-13 weeks later) and time 2 (follow-up- three month later)
Secondary outcomes (11)
Change in scores of the Instrumental Activities of Daily Living (IADL) scale
Measured: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
Change in scores of Reintegration to Normal Living Index (RNL)
Measured: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up-3 month later)
Change in scores of Short Form-12v2 Health Survey (SF-12v2)
Measured: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
change in scoe of New general self efficacy scale (NGSE)
Measured: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
Change in scores of Patient competency rating scale (PCRS)
Measured: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
Change in scores Self Regulation Skills Interview (SRSI)
Measured: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
Change in scores of Montreal Cognitive Assessment (MoCA)
Measured: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up-3 month later)
Change in scores of Trail making test (TMT)
Measured: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
Change in scores of zoo-map
Measured: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up-3 month later)
Change in scores of Dysexecutive Questionnaire (DEX)
Measured: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3month later)
Geriatric Depression Scale - short form (GDS-SF)
Measured: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start12 Mar 2017
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bait Balev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
- Investigators
- tal adamit, PHD student, Principal investigator, Maccabbi health center ashdod isreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925637
- Sponsor's protocol ID
- adamit_t
- Status last verified
- Feb 2019
- First submitted
- 3 Aug 2016
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Novel Meta-cognitive-functional Intervention (FACoT) for Individuals Post Mild-moderate Stroke
- ClinicalTrials.gov ID
- NCT02925637
- Acronym / sponsor ID
- adamit_t
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bait Balev HospitalUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- 12 Mar 2017 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 6 Oct 2016 (estimated)
- 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.
To develop and assess the effectiveness of a novel cognitive-functional intervention (FACoT) in occupational therapy for people after mild to moderate stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FACoT group | Experimental | Other: FaCoTtreatment group will receive FACoT, that include one to one 10 treatment sessions. the treatment sessions will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies |
| control group | No intervention | –control group receiving standard care - cognitive and functional assesment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years
- at least three years post stroke
- severity mild to moderate (NIHSS≤5)
- independent prior to the stroke
- can understand and speak Hebrew
Key exclusion criteria (2 listed)
- with no other neurological or psychiatric conditions
- without dementia
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 |
|---|---|---|
| FaCoTThe intervention will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies | Other | FACoT group |
Primary outcome
Change in scores of The Canadian Occupational Performance Measure (COPM)
Time frame: Change between baseline (week 0) to time 1 (post-intervention -10-13 weeks later) and time 2 (follow-up- three month later)
11 secondary outcomes
Change in scores of the Instrumental Activities of Daily Living (IADL) scale
Time frame: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
Change in scores of Reintegration to Normal Living Index (RNL)
Time frame: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up-3 month later)
Change in scores of Short Form-12v2 Health Survey (SF-12v2)
Time frame: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
change in scoe of New general self efficacy scale (NGSE)
Time frame: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
Change in scores of Patient competency rating scale (PCRS)
Time frame: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
Change in scores Self Regulation Skills Interview (SRSI)
Time frame: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
Change in scores of Montreal Cognitive Assessment (MoCA)
Time frame: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up-3 month later)
Change in scores of Trail making test (TMT)
Time frame: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
Change in scores of zoo-map
Time frame: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up-3 month later)
Change in scores of Dysexecutive Questionnaire (DEX)
Time frame: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3month later)
Geriatric Depression Scale - short form (GDS-SF)
Time frame: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later)
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 14 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
tal adamit, PHD student principal investigator
Maccabbi health center ashdod isreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FaCoT in people with Stroke, run by Bait Balev Hospital 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 5 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 14 Apr 2021. 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 Canadian Occupational Performance Measure (COPM) (time frame: Change between baseline (week 0) to time 1 (post-intervention -10-13 weeks later) and time 2 (follow-up- three month later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2021.