Clinical trial NCT06437587: Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction
Official title: Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: home-based rehabilitation
appropriate technology
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Harbin Medical University
First posted: 2024-05-31
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Primary outcomes:
measure: Motor Function
timeFrame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
measure: Balance
timeFrame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
Secondary outcomes:
measure: Activity of Daily Living
timeFrame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
measure: Exercise Adherence
timeFrame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
measure: Patient Satisfaction
timeFrame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
measure: Anxiety and Depression
timeFrame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
Other outcomes:
Locations:
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
Study officials:
References: