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

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06186739
• Other study ID #: SUMC-2023-061
• Secondary ID: B-2023-213
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: December 2023
• Source: Shantou University Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Physical Disability
• Stroke

Intervention

Behavioral:
• home-based motor rehabilitation training participated by caregivers
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.
• routine self-care
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shantou University Medical College	Affiliated Cancer Hospital of Shantou University Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Brunnstrom assessment	It is a common tool used in clinical assessment of motor function in stroke patients.	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	Modified Barthel Index	The Barthel Index is used to measure the activities of daily living. It has been widely used in China and more in line with Chinese culture. It is a 10-item scale of basic activities of daily living, focus on self-care (personal hygiene, bathing, feeding, toilet, dressing, bowel control, bladder control) and transfer (ambulation, chair/bed transfers, stair climbing), each item of the scale has five levels of scores and each item is weighted differently.	td: on the first day of intervention after allocation; t1: 1 week after discharge; t4: 4 weeks after discharge
Secondary	stroke-specific quality of life (SS-QOL)	The SS-QOL is a scale specifically designed for patients with stroke. There are 12 domains: energy (three items), family role (three items), language use (five items), movement (six items), mood (five items), personal personality (three items), self-help activities (five items), social role (five items), thinking ability (three items), upper limb function (five items), vision (three items), and occupation-production activities (three items).	td: on the first day of intervention after allocation; t1: 1 week after discharge; t4: 4 weeks after discharge
Secondary	National Institutes of Health Stroke Scale (NIHSS)	The degree of neurological deficit will be assessed by the NIHSS is currently one of the world's most common and easy-to-administer scales for assessing the degree of neurological deficit in stroke patients.	td: on the first day of intervention after allocation; t1: 1 week after discharge; t4: 4 weeks after discharge
Secondary	Chinese version of the Modified Caregiver Strain Index (C-M-CSI)	We will us the Chinese version of the Modified Caregiver Strain Index to measure caregiver-related burden.	td: on the first day of intervention after allocation; t1: 1 week after discharge; t4: 4 weeks after discharge