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

Shantou University Medical College0 sites58 target enrollmentDecember 30, 2023

ConditionsIschemic Stroke Physical Disability

Overview

Phase: N/A
Intervention: Not specified
Conditions: Ischemic Stroke
Sponsor: Shantou University Medical College
Enrollment: 58
Primary Endpoint: Motor Assessment Scale
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 30, 2023

End Date

August 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shantou University Medical College

Responsible Party

Principal Investigator

Ding Yue

nurse

Shantou University Medical College

Eligibility Criteria

Inclusion Criteria

•Patient inclusion criteria: (1) According to the international classification of diseases (ICD) definition of ischemic cerebral apoplexy, conform to the guidelines of diagnosis and treatment of acute ischemic stroke in China 2018 "diagnostic criteria, and confirmed by craniocerebral CT or MRI in the diagnosis of ischemic cerebral apoplexy patients. (2) on the day of discharge NIHSS score 15 points or less; (3) The patient's vital signs are stable and have clear consciousness.; (4) patients and their families for research cooperation and positive cooperation attitude.
•Caregiver inclusion criteria:1）who is an adult (18 years old or older); 2) physically healthy, with normal cognitive ability, living ability, language communication ability and learning ability;3) be the primary caregiver

Exclusion Criteria

•Patients' exclusion criteria: 1) Patients with unstable vital signs or unclear consciousness; 2) Patients who are unable to express language correctly due to aphasia or dysarthria; 3) The NIHSS score of the patient was more than 15 on the day of discharge; 4) Patients with other serious chronic or malignant diseases.
•Caregiver' exclusion criteria: 1) who with tumor, history of major surgery and history of severe trauma; 2) with mental illness

Outcomes

Primary Outcomes

Motor Assessment Scale

Time Frame: 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

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.

Secondary Outcomes

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)
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)
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)