Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction

NCT ID: NCT06437587

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-12-31

Brief Summary

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The goal of this clinical trial is to assess the effect of S-HRAT to improve patients' motor function and activities of daily living.

Detailed Description

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Limb dysfunction is the primary disability factor among stroke patients. However, due to various factors, most stroke survivors do not receive sufficient rehabilitation training after discharge. Home-based rehabilitation appropriate technology (S-HRAT) training could be a strategy to meet the patients' requirements for rehabilitation after hospital discharge. This study aims to assess the effect of a nursing intervention based on Cox's Interaction Model of Client Health Behavior (IMCHB) with the application of S-HRAT to improve patients' motor function and activities of daily living.

In this pilot trial, 36 stroke survivors with limb dysfunction will be screened for inclusion before hospital discharge and randomly assigned to the experimental or control group with their informed consent. The control group(n=18) will receive the usual care provided by the hospital. The experimental group(n=18) will receive usual care and an 8-week S-HRAT training program. This nursing interventions use Cox's IMCHB as a theoretical framework that consists of rehabilitation exercises and the provision of health information. Baseline assessments will be conducted on the day before hospital discharge, and outcomes will be assessed at 8 weeks and 12 weeks after discharge. The primary outcome is change in motor function 8 weeks after discharge, and the secondary outcomes include the activities of daily living, anxiety, depression, exercise adherence, and patient satisfaction.

This study is the first of its kind conducted in China to use Cox's IMCHB as a framework to guide the development of the S-HRAT training program. Our pilot will determine if such an approach is feasible and effective in enhancing motor function and improving the activities of daily living post-stroke after discharge.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Due to the nature of the intervention, it is impossible to blind the researcher of the intervention who will deliver the intervention. Therefore, the participants and the outcome assessor will be blinded. The outcome assessor will be blinded to the allocation throughout the study and will independently assess all outcomes at T0, T1, and T2 for both groups.

Study Groups

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intervention group

Home-based rehabilitation appropriate technology (S-HRAT) training

Group Type EXPERIMENTAL

Home-based rehabilitation appropriate technology (S-HRAT) training

Intervention Type OTHER

The S-HRAT training instruction consists of two phases: in-hospital training and post-discharge remote home training. Based on the S-HRAT list, we select individualized home rehabilitation training exercises for the participants and conduct five offline training instruction sessions one week before discharge to ensure that the participants master the correct method for each exercise and clarify precautions. At discharge, participants will receive an S-HRAT brochures, which will include detailed text, pictures and video demonstrations of exercises, to visualize the rehabilitation instructions and make them easy to understand. Participants learn how to use the S-HRAT booklet and follow a daily training program to complete the prescribed content. They will be asked to record a video of their training and send it to the researcher via WeChat for monitoring purposes and feedback.

control group

Routine discharge instructions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home-based rehabilitation appropriate technology (S-HRAT) training

The S-HRAT training instruction consists of two phases: in-hospital training and post-discharge remote home training. Based on the S-HRAT list, we select individualized home rehabilitation training exercises for the participants and conduct five offline training instruction sessions one week before discharge to ensure that the participants master the correct method for each exercise and clarify precautions. At discharge, participants will receive an S-HRAT brochures, which will include detailed text, pictures and video demonstrations of exercises, to visualize the rehabilitation instructions and make them easy to understand. Participants learn how to use the S-HRAT booklet and follow a daily training program to complete the prescribed content. They will be asked to record a video of their training and send it to the researcher via WeChat for monitoring purposes and feedback.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age≥18;
* Patients diagnosed with cerebrovascular disease who have cerebral infarction or cerebral hemorrhage based on cranial CT or MRI and meet the diagnostic criteria;
* Patients are in the non-acute phase, meaning between two weeks and six months after the onset of the disease;
* Patients with limb dysfunction.

Exclusion Criteria

* Return to a hospital or rehabilitation facility after discharge;
* The patient has a history of mental illness and dyslexia;
* Patients have a combination of serious, life-threatening conditions.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harbin Medical University

OTHER

Sponsor Role collaborator

Xi Chen

OTHER

Sponsor Role lead

Responsible Party

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Xi Chen

researcher

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xi Chen

Role: CONTACT

15945313760

Facility Contacts

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Xi Chen, Master

Role: primary

15945313760

YuMei Lv, Professor

Role: backup

13804679642

Other Identifiers

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HMUDQ20231116205

Identifier Type: -

Identifier Source: org_study_id

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