Clinical trial NCT06186739: Rehabilitation Training Participated by Caregivers in Ischemic Stroke: a Randomized Controlled Trial to Test the Effect of Home-based Rehabilitation Intervention on Physical Function.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Physical Disability
Keywords: Ischemic Stroke
Rehabilitation
Home Nursing
Caregiver
Physical function
Caregiver Burden
Lead sponsor: Shantou University Medical College
Sponsor class: OTHER
Collaborators: name: Affiliated Cancer Hospital of Shantou University Medical College
First posted: 2024-01-02
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Motor Assessment Scale
timeFrame: 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:
measure: The Brunnstrom assessment
timeFrame: 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
measure: Modified Barthel Index
timeFrame: td: on the first day of intervention after allocation; t1: 1 week after discharge; t4: 4 weeks after discharge
measure: stroke-specific quality of life (SS-QOL)
timeFrame: td: on the first day of intervention after allocation; t1: 1 week after discharge; t4: 4 weeks after discharge
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: td: on the first day of intervention after allocation; t1: 1 week after discharge; t4: 4 weeks after discharge
measure: Chinese version of the Modified Caregiver Strain Index (C-M-CSI)
timeFrame: td: on the first day of intervention after allocation; t1: 1 week after discharge; t4: 4 weeks after discharge
Other outcomes:
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