Rehabilitation Training Participated by Caregivers in Ischemic Stroke: a Randomized Controlled Trial to Test the Effect of Home-based Rehabilitation Intervention on Physical Function.

NCT06186739 | Unknown DMC

• 2 other identifiers: SUMC-2023-061B-2023-213
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical randomized control trial is to test the effect of home-based motor rehabilitation training participated by caregivers on physical function in patients with ischemic stroke \]. The main question\[s\] it aims to answer are:

• Dose this kind of intervention method can improve the function of ischemic cerebral apoplexy patients is physical activity?
• Does this intervention reduce the caregiver-related burden of patients with ischemic stroke? Participants will be randomly assigned to: (1) home-based motor rehabilitation training participated by caregivers (intervention group or (2) routine self-care group (control group). Both groups will receive assessment and health guidance on the day of discharge, with the intervention group receiving an additional home-based training program and supervision. The two groups will be followed up every week after discharge. Researchers will compare two groups to see if has great effects on physical function.

Conditions

Ischemic Stroke; Physical Disability

Keywords

Ischemic Stroke; Rehabilitation; Home Nursing; Caregiver; Physical function; Caregiver Burden

Outcome Measures

Primary Outcomes (1)

• Motor Assessment Scale

  Patient's motor status will be assessed using the Motor Assessment Scale,on which scale has eight areas of motor function, including supine to side lying, supine to sitting over side of bed, balanced sitting, sitting to standing, walking, upper-arm function, hand movements and advanced hand activities.

  td:on the first day of intervention after allocation; t1: 1 week after discharge; t2: 2 weeks after discharge; t3: 3 weeks after discharge; t4: 4 weeks after discharge

Secondary Outcomes (5)

• The Brunnstrom assessment

  td: on the first day of intervention after allocation; t1: 1 week after discharge; t2: 2 weeks after discharge; t3: 3 weeks after discharge; t4: 4 weeks after discharge

• Modified Barthel Index

  td: on the first day of intervention after allocation; t1: 1 week after discharge; t4: 4 weeks after discharge

• stroke-specific quality of life (SS-QOL)

  td: on the first day of intervention after allocation; t1: 1 week after discharge; t4: 4 weeks after discharge

• National Institutes of Health Stroke Scale (NIHSS)

  td: on the first day of intervention after allocation; t1: 1 week after discharge; t4: 4 weeks after discharge

• Chinese version of the Modified Caregiver Strain Index (C-M-CSI)

  td: on the first day of intervention after allocation; t1: 1 week after discharge; t4: 4 weeks after discharge

Study Arms (2)

home-based motor rehabilitation training participated by caregivers

EXPERIMENTAL

The patients in this group received face-to-face learning of rehabilitation skills when they were discharged from the hospital. The main learning contents of patients are: how to carry out limb rehabilitation training at home? when to carry out rehabilitation training? and how to choose the most appropriate rehabilitation training content? Members of the rehabilitation nursing team should assist patients in setting rehabilitation goals, help patients make weekly rehabilitation plans, and distribute learning manuals and video learning materials to patients for review at home. The rehabilitation nursing team conducts online follow-up of patients every other week to assess whether patients have achieved short-term goals, adjust or add rehabilitation contents for patients, and reconfirm the intensity of home-based training of patients. answer the questions raised by the patient during the rehabilitation process at home and encourage the patient to maintain rehabilitation.

Behavioral: home-based motor rehabilitation training participated by caregivers

routine self-care group

ACTIVE COMPARATOR

The control group will be routinely given post-discharge health education, such as secondary prevention measures, education on medication adherence, universal guidance on the content of home care, universal rehabilitation-related education such as correct limb positioning, post-discharge precautions, and medical referral-related assistance.

Behavioral: routine self-care

Interventions

home-based motor rehabilitation training participated by caregivers BEHAVIORAL

The knowledge provider was a multi-disciplinary home-based rehabilitation nursing team, which is composed of advanced practice nurse (APN) who engaged in professional rehabilitation of stroke, neurologists, rehabilitation doctors and physical therapists. Among them, APN mainly carry out and supervise family rehabilitation education and all members are collectively responsible for the adjustment and optimization of the program content. After the assessment is completed, the patient's current functional status will be confirmed. based on this, team members recommend home-exercise items that match the patient's motor function state . In this intervention programme, the content of the intervention was developed based on the recommendations of internationally published guidelines related to the rehabilitation of ischemic patients, with some adjustments to consider the cultural appropriateness of implementation in China.

home-based motor rehabilitation training participated by caregivers

routine self-care BEHAVIORAL

the patients in this group will be routinely given post-discharge health education, such as secondary prevention measures, education on medication adherence, universal guidance on the content of home care, universal rehabilitation-related education such as correct limb positioning, post-discharge precautions, and medical referral-related assistance.

routine self-care group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Shantou University Medical College: lead
• Affiliated Cancer Hospital of Shantou University Medical College: collaborator

MeSH Terms

Conditions

Ischemic Stroke; Caregiver Burden

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 2, 2024
• Study Start: December 30, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share