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

NCT06754566 | Recruiting

• 1 other identifier: N202403026
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 5

Brief 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. 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? 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.

Conditions

Stroke

Keywords

Stroke; Caregiver-assisted rehabilitation; Strategy training; Activity limitations

Outcome Measures

Primary Outcomes (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.

  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)

• Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)

  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)

• EuroQol-5D-3L (EQ-5D-3L)

  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)

• Stroke Self-Efficacy Questionnaires (SSEQ)

  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)

• Fugl-Meyer Motor Assessment (FMA)

  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)

• Montreal Cognitive Assessment (MoCA)

  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)

Other Outcomes (4)

• National Institutes of Health Stroke Scale (NIHSS)

  At baseline, within 4 weeks after enrollment

• modified Rankin Scale (mRS)

  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)

• Berg Balance Scale (BBS)

  At baseline, within 4 weeks after enrollment

Study Arms (3)

Caregiver-Assisted Rehabilitation with Strategy Training (CAR-ST)

EXPERIMENTAL

Trained 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.

Behavioral: Caregiver-Assisted Rehabilitation with Strategy Training

Strategy Training

ACTIVE COMPARATOR

Participants 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.

Behavioral: Strategy Training

Education

PLACEBO COMPARATOR

In 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.

Behavioral: Education

Interventions

Caregiver-Assisted Rehabilitation with Strategy Training BEHAVIORAL

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.

Also known as: CAR-ST

Caregiver-Assisted Rehabilitation with Strategy Training (CAR-ST)

Strategy Training BEHAVIORAL

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.

Also known as: ST

Strategy Training

Education BEHAVIORAL

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.

Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (5)

Taipei Tzu Chi Hospital

New Taipei City, 231, Taiwan

NOT YET RECRUITING

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, 235, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

NOT YET RECRUITING

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Taipei Municipal Wanfang Hospital

Taipei, 116, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Feng-Heng Chang, ScD

  Graduate Institute of Injury Prevention and Control, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang, ScD

CONTACT

+886-2-66202589; ipc@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A researcher is responsible for the randomization process and the results are coded with predefined IDs that investigators and outcomes assessors are unaware of the meaning.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 1, 2025
• Study Start: January 17, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

TW (5)