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

Shantou University Medical College

Status: Not yet enrolling

Conditions: Ischemic Stroke; Physical Disability

Treatments: Behavioral: routine self-care; Behavioral: home-based motor rehabilitation training participated by caregivers

Study type: Interventional

Funder types: Other

Identifiers

NCT06186739

SUMC-2023-061

B-2023-213 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

home-based motor rehabilitation training participated by caregivers

Experimental group

Description:

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.

Treatment:

Behavioral: home-based motor rehabilitation training participated by caregivers

routine self-care group

Active Comparator group

Description:

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.

Treatment:

Behavioral: routine self-care