StrokeNCT06437587
Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction
A study testing Home-based rehabilitation appropriate technology (S-HRAT) training in people with Stroke, run by Xi Chen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Home-based rehabilitation appropriate technology (S-HRAT) training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001
Xi Chen, Master, 15945313760, chenxi3760@163.com
YuMei Lv, Professor, 13804679642, lvyumeihua@163.com
About this study
The goal of this clinical trial is to assess the effect of S-HRAT to improve patients' motor function and activities of daily living.
Read the 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.
- Conditions
- Stroke
- Being tested
- Home-based rehabilitation appropriate technology (S-HRAT) training
- Keywords
- home-based rehabilitation, appropriate technology
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based rehabilitation appropriate technology (S-HRAT) trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Home-based rehabilitation appropriate technology (S-HRAT) training Receives: Other: Home-based rehabilitation appropriate technology (S-HRAT) training |
| control group | No intervention | Routine discharge instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Function
The motor function of the patients is measured using the Motor Assessment Scale (MAS) for stroke. MAS is methodologically simple, targeted, and easily generalizable for motor function assessment in stroke patients, as well as reliable and valid. The scale consists of nine items, each of which is scored from 0 to 6 out of 48, with the ninth item not scoring. Higher scores indicate better motor function.
Measured: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
Balance
Balance was measured using the Berg Balance Scale (BBS). The scale consists of 14 items, including sitting to standing, standing independently, walking independently, and standing to sit, and each item is scored on five functional levels: 0, 1, 2, 3, and 4. A score of 4 indicates that the action under examination can be performed normally. In contrast, a score of 0 indicates that it cannot be performed or requires significant assistance. The total possible score is 56, with higher scores indicating better balance.
Measured: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
Secondary outcomes (4)
Activity of Daily Living
The Modified Barthel Index(MBI) is used to measure the activity of daily living. The scale consists of ten items, including eating, bathing, grooming, dressing, toileting, bed and chair transfers, walking on level ground, walking up and downstairs, bowel control, and urinary control. The possible score ranges from 0 to 100, and a higher score means greater independence
Measured: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
Exercise Adherence
The Functional Exercise Adherence Scale for Stroke Patients (questionnaire of exercise adherence, EAQ) developed by Chinese author Beilei Lin in 2013 was used to assess patients' adherence to rehabilitation exercises. The scale consists of three dimensions: physical participation in exercise, monitoring of exercise effects, and active adherence to seeking exercise advice. Each item is scored using a Likert scale ranging from 0 to 4, with a total score ranging from 14 to 56. A higher score indicates a higher level of exercise adherence.
Measured: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
Patient Satisfaction
The Nursing Job Satisfaction Questionnaire (Client Satisfaction Test, CST) was developed by Bear Bowers based on the IMCHB model and comprises 12 items across six domains: emotional support, health information, decision control, professional skills, service accessibility, and overall satisfaction. The rating method employs a scale of 1 to 5 points, representing five options "very satisfied," "quite satisfied," "not sure," "not too satisfied," and "very dissatisfied." The total scale thus ranges from 12 to 60 points. A higher score on the scale indicates a higher level of patient satisfaction.
Measured: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
Anxiety and Depression
The Chinese version of the Hospital Anxiety and Depression Scale (HADS) is employed to assess the anxiety and depression levels of patients. The HADS is a frequently used instrument for assessing the severity of anxiety and depression in patients. It is a 14-item instrument comprising two subscales: anxiety (HADS-A, 7 items) and depression (HADS-D, 7 items). Each item is rated on a 4-point Likert scale, ranging from 0 for "no problem" to 3 for "severe problem," with higher scores indicating higher levels of anxiety and depression.
Measured: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jun 2024
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi Chen
- Sponsor type
- University, hospital or other
- Collaborators
- Harbin Medical University
- Responsible party
- Sponsor-investigator, Xi Chen, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437587
- Sponsor's protocol ID
- HMUDQ20231116205
- Status last verified
- Sep 2024
- First submitted
- 25 May 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction
- ClinicalTrials.gov ID
- NCT06437587
- Acronym / sponsor ID
- HMUDQ20231116205
- Conditions
- Stroke
- Keywords
- home-based rehabilitation, appropriate technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Xi ChenUniversity, hospital or other
- Collaborators
- Harbin Medical University
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Home-based rehabilitation appropriate technology (S-HRAT) trainingHome-based rehabilitation appropriate technology (S-HRAT) training |
| control group | No intervention | –Routine discharge instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based rehabilitation appropriate technology (S-HRAT) trainingThe 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. | Other | intervention group |
Primary outcome
Motor Function
Time frame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
The motor function of the patients is measured using the Motor Assessment Scale (MAS) for stroke. MAS is methodologically simple, targeted, and easily generalizable for motor function assessment in stroke patients, as well as reliable and valid. The scale consists of nine items, each of which is scored from 0 to 6 out of 48, with the ninth item not scoring. Higher scores indicate better motor function.
Balance
Time frame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
Balance was measured using the Berg Balance Scale (BBS). The scale consists of 14 items, including sitting to standing, standing independently, walking independently, and standing to sit, and each item is scored on five functional levels: 0, 1, 2, 3, and 4. A score of 4 indicates that the action under examination can be performed normally. In contrast, a score of 0 indicates that it cannot be performed or requires significant assistance. The total possible score is 56, with higher scores indicating better balance.
4 secondary outcomes
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based rehabilitation appropriate technology (S-HRAT) training in people with Stroke, run by Xi Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xi Chen (15945313760, chenxi3760@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Function (time frame: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.