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StrokeCAR-STNCT06754566

A Caregiver-Assisted Rehabilitation With Strategy Training (CAR-ST) for Stroke Patients

A study testing Caregiver-Assisted Rehabilitation with Strategy Training, Strategy Training and Education in people with Stroke, run by Taipei Medical University at 5 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this randomized controlled trial is to examine if involving the caregivers in the strategy training (i.e. caregiver-assisted rehabilitation with strategy training, CAR-ST) works to improve activity functions in community-dwelling adults after stroke. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Caregiver-Assisted Rehabilitation with Strategy Training, Strategy Training and Education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
261 participants
Where
5 sitesTaiwan
Study dates
17 Jan 2025to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Being willing to provide informed consent
  • Diagnosis with ischemic and/or hemorrhagic stroke
  • Modified Rankin Scale (mRS) ranges from 2 to 4
  • Rehabilitation frequency less than 3 days per week
  • Having a healthy caregiver

Who cannot join

  • Undergoing palliative care
  • Major diseases or severe conditions influencing study participation, such as global aphasia, dementia, multiple organ failure, immobilization due to fracture, etc
  • Moderate post-stroke cognitive impairment, with Montreal Cognitive Assessment score <22
  • Pre-stroke mRS > 1
  • Participating in other interventional study concurrently.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

Taiwan5 sites, 5 recruiting
  • Taipei Tzu Chi Hospital

    New Taipei City, 231

    Chu, MD, m513108006@tmu.edu.tw

    Not yet recruiting
  • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

    New Taipei City, 235

    Chen, MD, b8601084@tmu.edu.tw

    Recruiting
  • National Taiwan University Hospital

    Taipei, 100

    Chen, MD, wenshiang@gmail.com

    Not yet recruiting
  • Taipei Medical University Hospital

    Taipei, 110

    Kang, MD, jhk@tmu.edu.tw

    Recruiting
  • Taipei Municipal Wanfang Hospital

    Taipei, 116

    Lin, MD, solin1103@tmu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: A Caregiver-Assisted Rehabilitation With Strategy Training (CAR-ST) for Stroke Patients With Functional Limitations: A MultiCenter, 3-Arm Randomized Trial

The goal of this randomized controlled trial is to examine if involving the caregivers in the strategy training (i.e. caregiver-assisted rehabilitation with strategy training, CAR-ST) works to improve activity functions in community-dwelling adults after stroke. The main questions it aims to answer are:

Does CAR-ST and strategy training alone lead to greater improvements in activity performance among stroke survivors relative to the control intervention with education? Does CAR-ST outperform strategy training alone in the efficacy of activity outcomes? Do the activity effects of CAR-ST transfer to the impairment and participation domains of outcomes?

Read more

Researchers will compare the efficacy of the CAR-ST intervention against strategy training alone or control intervention (education program) to see if caregivers contribute to post-stroke functional improvements.

Participants will:

  • receive CAR-ST, strategy training only, or an education program 1 to 2 sessions per week until finishing 10 sessions.
  • be assessed clinical outcomes at 4 times: pre-intervention, post-intervention, 3-month, and 6-month follow-up.
Read the detailed description

Stroke is the leading cause of enduring disability worldwide, contributing to widespread impairments in survivors, thereby impeding various activities of daily life. Despite the effectiveness of intensive inpatient rehabilitation in mitigating deficits and activity limitations, maintaining an optimal treatment dose for patients transitioning to home remains a challenge. To address this gap, the integration of caregivers into home-based, evidence-supported rehabilitation emerges as a promising approach, yet its efficacy requires comprehensive examination. This clinical trial aims to assess the efficacy of a newly developed intervention, caregiver-assisted rehabilitation with strategy training (CAR-ST), in enhancing the activity performance of stroke survivors.

A single-blinded, three-arm randomized controlled trial will be executed, comparing the efficacy of the CAR-ST intervention against strategy training alone or attentional control through education. A procedure of randomization with minimization will be conducted by a researcher who is independent of the investigation and outcome assessments. Eligible stroke survivors and their caregivers will be recruited from collaborative hospitals in Northern Taiwan and randomly assigned with even possibility. Longitudinal evaluations will be conducted at baseline (T1), post-intervention (T2), 3-month (T3), and 6-month (T4) follow-ups, utilizing the Activity Measure for Post-Acute Care (AM-PAC) outpatient shortform as the primary outcome. Secondary outcomes will include the Participation Measure-3 Domains, 4 Dimensions (PM-3D4D), EuroQol-5D (EQ-5D), Stroke Self-Efficacy Questionnaires (SSEQ), Fugl-Meyer Assessment (FMA), Montreal Cognitive Assessment (MoCA), and Goal Attainment Scaling (GAS). Under the principles of modified intention-to-treat, quantitative data will be analyzed using multiple linear regression models and mixed-effects regression models. If data is lost at follow-up, inferential statistical analyses for group comparisons will be conducted both with or without multiple imputation. Furthermore, qualitative in-depth interviews with participants, caregivers, and therapists will be conducted post-intervention. These interviews will explore experiences, satisfaction, and perceived effectiveness of the intervention. Transcribed data will undergo coding by two independent coders and subsequent analysis through the thematic analysis method.

Conditions
Stroke
Being tested
Caregiver-Assisted Rehabilitation with Strategy Training, Strategy Training, Education
Keywords
Stroke, Caregiver-assisted rehabilitation, Strategy training, Activity limitations
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caregiver-Assisted Rehabilitation with Strategy TrainingBehavioural

    Also called CAR-ST

    CAR-ST is a home-based rehabilitation that guides both stroke survivors and their caregivers to implement strategy training for addressing daily activity limitations after stroke. The caregiver, as an active partner, not only supervises the participant but also co-participates in the practice. Caregivers are instructed on when and how to provide assistance during task practice, using physical, verbal, or visual guidance. As the participant's performance improves, the caregiver is empowered to motivate them to exert greater efforts, encouraging higher repetitions, longer durations of the same task, and an increased level of difficulty.

  • Strategy TrainingBehavioural

    Also called ST

    Compared to CAR-ST, ST is a home-based rehabilitation that guides stroke survivors only to implement strategy training for addressing daily activity limitations after stroke.

  • EducationBehavioural

    Stroke-related information and knowledge that includes stroke subtypes and their etiology, risk factors of primary and secondary stroke, healthy lifestyles, common sequala, and adaptive skills for impaired functions are provided.

Study groups in NCT06754566
Study groupRoleWhat they receive
Caregiver-Assisted Rehabilitation with Strategy Training (CAR-ST)ExperimentalTrained therapists visit each participant once or twice weekly for 60 minutes. The program consists of 10 therapist-guided sessions over a maximum of 6 weeks and includes the following active ingredients: self-selected activity-based goals, dynamic performance analysis, global strategy ("Goal-PlanDo-Check"), massed practice, variable practice, increasing task difficulty, explicit and implicit feedback, guided discovery, action observation, and social interaction.
Receives: Behavioral: Caregiver-Assisted Rehabilitation with Strategy Training
Strategy TrainingActive comparatorParticipants assigned to the ST group receive a protocol similar to CAR-ST, with the distinction that their caregivers are not asked to co-participate in the intervention, and they are not instructed (by the research therapist) to provide assistance during at-home practice.
Receives: Behavioral: Strategy Training
EducationPlacebo comparatorIn this arm, participants receive a dose-matched intervention with 10 visits by well-trained research therapists through face-to-face talks (primary approach), video conference, or telephone calls. Sessions focus on instruction on general information regarding stroke and rehabilitation, and a summary of participants' condition and progression is provided for each visit.
Receives: Behavioral: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms

    The AM-PAC measures the difficulty is performing three activity domains: Basic Mobility (18 activities), Daily Activity (15 activities), and Applied Cognition (19 activities) on a 4-point scale. In this trial, Applied Cognition domain is viewed as a secondary outcome. A trained research assistant performs AM-PAC face-to-face with participants.

    Measured: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)

Secondary outcomes (6)
  1. Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)

    PM-3D4D consists of 24 items for evaluating three domains of participation, which are community, productivity, and social. Participants will be asked to rate all items on the four distinct dimensions: (1) diversity, (2) frequency, (3) desire for change, and (4) perceived difficulty. A trained research assistant performs PM-3D4D face-to-face with participants.

    Measured: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)

  2. EuroQol-5D-3L (EQ-5D-3L)

    EuroQol-5D-3L (EQ-5D-3L) is a self-reported measurement that assesses participants' health-related quality of life across five domains: mobility, self-care, usual activity, pain/discomfort, anxiety/depression. In each domain, the assessment utilizes three levels to indicate the extent of problem: no problem, moderate problems, and extreme problems. A trained research assistant performs EQ-5D-3L face-to-face with participants.

    Measured: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)

  3. Stroke Self-Efficacy Questionnaires (SSEQ)

    SSEQ measures individual confidence in functional performance after stroke [64]. It contains 13 items, and each item is rated on a 10-point scalar from 0 (not at all confident) to 10 (very confident). A trained research assistant performs SSEQ face-to-face with participants.

    Measured: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)

  4. Fugl-Meyer Motor Assessment (FMA)

    FMA measures the motor impairments of hemiplegia and includes a proximal subscale of upper extremity (0-42 points) for the shoulder/elbow/forearm, distal subscale of upper extremity (0-24 points) for the wrist/hand, and a lower extremity subscale (0-34 points) A trained research assistant performs FMA face-to-face with participants.

    Measured: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)

  5. Montreal Cognitive Assessment (MoCA)

    MoCA with 30 items evaluates the cognitive functions (range: 0-30). This assessment covers domains such as visuospatial/executive skills, naming, memory, attention, language, abstraction, delayed recall, and orientation. A trained research assistant performs MoCA face-to-face with participants.

    Measured: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)

  6. Goal Attainment Scale (GAS)

    GAS is used to quantify the achievement of goals (range -3 to 2 for each goal). A trained research assistant performs GAS face-to-face with participants.

    Measured: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2025
  2. Study start17 Jan 2025
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
261 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06754566
Sponsor's protocol ID
N202403026
Acronym
CAR-ST
Status last verified
Feb 2025
First submitted
30 Dec 2024
Last updated
17 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Caregiver-Assisted Rehabilitation with Strategy Training, Strategy Training and Education in people with Stroke, run by Taipei Medical University at 5 sites in Taiwan.

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 5 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Taiwan. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chang, ScD (+886-2-66202589 ext. 16040, ipc@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms (time frame: 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)). 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 17 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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