Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home-based rehabilitation appropriate technology (S-HRAT) training.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Other 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
Primary outcome measures
- Motor Function [Time frame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).]
- Balance [Time frame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).]
Secondary outcome measures (4)
- Activity of Daily Living [Time frame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).]
- Exercise Adherence [Time frame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).]
- Patient Satisfaction [Time frame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).]
- Anxiety and Depression [Time frame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Daqing Oilfield General Hospital — Daqing
Identifiers
NCT: NCT06437587 · HMUDQ20231116205