StrokeNCT06234657
Effectiveness of Telerehabilitation on the Performance of Post-stroke Patients' Daily Living Activities and Evaluation of Satisfaction in Post-stroke Patients in Vietnam
A study testing Telerehabilitation for stroke patient in people with Stroke and Telerehabilitation, run by University of Science Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This study aims to evaluate the efficacy of telerehabilitation on stroke patients' capability to perform ADLs after three months of telerehabilitation intervention. Additionally, the investigators also conducted a survey on the satisfaction of patients after telerehabilitation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Telerehabilitation, Acute Stroke
- What is being tested?
- Telerehabilitation for stroke patient
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2023to 15 Jun 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: Over 18 years old
- Diagnosis: First stroke
- Stroke Severity: National Institutes of Health Stroke Scale (NIHSS) score between 5 and 15 (moderate impairment)
- Support System: Has a caregiver available during the research process
- Technology Access: Possesses a smartphone or computer with internet connection and online meeting application capabilities
Who cannot join
- Existing Conditions: Severe cognitive impairment, sensory impairment, language disorder, or musculoskeletal diseases limiting motor function
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
This study aims to evaluate the efficacy of telerehabilitation on stroke patients' capability to perform ADLs after three months of telerehabilitation intervention. Additionally, the investigators also conducted a survey on the satisfaction of patients after telerehabilitation
Read the detailed description
The performance of stroke patients' daily living activities (ADLs) is severely affected because of hemiplegia. The consequences of stroke on patients can lead to a financial and welfare burden on society. Thus, it is vital to provide a rehabilitation program to enhance patients' performance in ADLs and help them become more independent. This study aims to evaluate the efficacy of telerehabilitation on stroke patients' capability to perform ADLs after three months of telerehabilitation intervention. Additionally, the investigators also conduct a survey on the satisfaction of patients after telerehabilitation. The investigators will recruit 32 stroke patients from five hospitals in Vietnam. All subjects will be provided the three-month treatment that includes video-based rehabilitation and the online meeting section. The investigators will use the Barthel Index (BI) to evaluate the intervention and use the Paired T-test to review the results. Evaluation of the satisfaction of stroke patients with telerehabilitation is conducted by Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ).
- Conditions
- Stroke, Telerehabilitation, Acute Stroke
- Being tested
- Telerehabilitation for stroke patient
- Keywords
- Stroke, Telerehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation for stroke patientBehavioural
The subjects of the study were intervened by telerehabilitation through video instructions and online group training via Online meeting software. The content of the intervention program included upper limb exercises, transfer, and ambulation functions. This training program was designed based on the clinical practice guidelines for post-stroke physiotherapy management from the United States Department of Veterans Affairs and the guidelines for the diagnosis, and treatment of rehabilitation stroke patients of the Vietnam Ministry of Health. The training results of the subjects will be evaluated by the Barthel Index
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation for stroke patient | Experimental | Not described Receives: Behavioral: Telerehabilitation for stroke patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability to perform several activities of daily living will be assess by Barthel Index (BI)
Barthel Index (BI) is a scale that measures the ability to perform several activities of daily living. It consists of 10 items with a total score of 0 (lowest ability) to 100 (highest ability) . The 10 items of the scale refer to the patient's ability to eat, perform personal hygiene, bathe, dress, get on and off the toilet, control the bladder, control the bowels, move from a wheelchair to a bed and back, walk, and climb stairs.
Measured: The patient was assessed using the BI scale at three time points: at the start of the study (discharge), one month after intervention and three months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion15 Jun 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The telerehabilitation program for stroke patients is provided via a remote system with caregiver support during 3 months
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Science Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doan Nguyen, University of Science Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234657
- Sponsor's protocol ID
- UniversitySHCMC
- Status last verified
- May 2024
- First submitted
- 22 Jan 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To ensure participant confidentiality, all information will be encrypted and anonymized. Research results will be used for scientific purposes only.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Telerehabilitation on the Performance of Post-stroke Patients' Daily Living Activities and Evaluation of Satisfaction in Post-stroke Patients in Vietnam
- ClinicalTrials.gov ID
- NCT06234657
- Acronym / sponsor ID
- UniversitySHCMC
- Conditions
- Stroke, Telerehabilitation, Acute Stroke
- Keywords
- Stroke, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Science Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 31 Jan 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.
This study aims to evaluate the efficacy of telerehabilitation on stroke patients' capability to perform ADLs after three months of telerehabilitation intervention. Additionally, the investigators also conducted a survey on the satisfaction of patients after telerehabilitation
Detailed description
The performance of stroke patients' daily living activities (ADLs) is severely affected because of hemiplegia. The consequences of stroke on patients can lead to a financial and welfare burden on society. Thus, it is vital to provide a rehabilitation program to enhance patients' performance in ADLs and help them become more independent. This study aims to evaluate the efficacy of telerehabilitation on stroke patients' capability to perform ADLs after three months of telerehabilitation intervention. Additionally, the investigators also conduct a survey on the satisfaction of patients after telerehabilitation. The investigators will recruit 32 stroke patients from five hospitals in Vietnam. All subjects will be provided the three-month treatment that includes video-based rehabilitation and the online meeting section. The investigators will use the Barthel Index (BI) to evaluate the intervention and use the Paired T-test to review the results. Evaluation of the satisfaction of stroke patients with telerehabilitation is conducted by Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The telerehabilitation program for stroke patients is provided via a remote system with caregiver support during 3 months
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation for stroke patient | Experimental | Behavioral: Telerehabilitation for stroke patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: Over 18 years old
- Diagnosis: First stroke
- Stroke Severity: National Institutes of Health Stroke Scale (NIHSS) score between 5 and 15 (moderate impairment)
- Support System: Has a caregiver available during the research process
- Technology Access: Possesses a smartphone or computer with internet connection and online meeting application capabilities
Key exclusion criteria (1 listed)
- Existing Conditions: Severe cognitive impairment, sensory impairment, language disorder, or musculoskeletal diseases limiting motor function
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 |
|---|---|---|
| Telerehabilitation for stroke patientThe subjects of the study were intervened by telerehabilitation through video instructions and online group training via Online meeting software. The content of the intervention program included upper limb exercises, transfer, and ambulation functions. This training program was designed based on the clinical practice guidelines for post-stroke physiotherapy management from the United States Department of Veterans Affairs and the guidelines for the diagnosis, and treatment of rehabilitation stroke patients of the Vietnam Ministry of Health. The training results of the subjects will be evaluated by the Barthel Index | Behavioural | Telerehabilitation for stroke patient |
Primary outcome
The ability to perform several activities of daily living will be assess by Barthel Index (BI)
Time frame: The patient was assessed using the BI scale at three time points: at the start of the study (discharge), one month after intervention and three months after the intervention
Barthel Index (BI) is a scale that measures the ability to perform several activities of daily living. It consists of 10 items with a total score of 0 (lowest ability) to 100 (highest ability) . The 10 items of the scale refer to the patient's ability to eat, perform personal hygiene, bathe, dress, get on and off the toilet, control the bladder, control the bowels, move from a wheelchair to a bed and back, walk, and climb stairs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Undecided. To ensure participant confidentiality, all information will be encrypted and anonymized. Research results will be used for scientific purposes only.
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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 Telerehabilitation for stroke patient in people with Stroke and Telerehabilitation, run by University of Science Ho Chi Minh City at 1 site in Vietnam.
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 5 inclusion and 1 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 9 May 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 Vietnam. 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 Doan Nguyen, master (+84392332846, doannguyenvltl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability to perform several activities of daily living will be assess by Barthel Index (BI) (time frame: The patient was assessed using the BI scale at three time points: at the start of the study (discharge), one month after intervention and three months after the intervention). 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 9 May 2024.