- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06234657
Effectiveness of Telerehabilitation on the Performance of Post-stroke Patients' Daily Living Activities and Evaluation of Satisfaction in Post-stroke Patients in Vietnam
May 6, 2024 updated by: Doan Nguyen, University of Science Ho Chi Minh City
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Doan Nguyen, master
- Phone Number: +84392332846
- Email: doannguyenvltl@gmail.com
Study Contact Backup
- Name: Linh Pham, Bacholer
- Phone Number: +84778713174
- Email: ptlinh2702@gmail.com
Study Locations
-
-
-
Ho Chi Minh, Vietnam, 700000
- Recruiting
- University of Medicine and Pharmacy at Ho Chi Minh City
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Existing Conditions: Severe cognitive impairment, sensory impairment, language disorder, or musculoskeletal diseases limiting motor function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telerehabilitation for stroke patient
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 15, 2024
Study Registration Dates
First Submitted
January 22, 2024
First Submitted That Met QC Criteria
January 22, 2024
First Posted (Actual)
January 31, 2024
Study Record Updates
Last Update Posted (Actual)
May 9, 2024
Last Update Submitted That Met QC Criteria
May 6, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UniversitySHCMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
To ensure participant confidentiality, all information will be encrypted and anonymized.
Research results will be used for scientific purposes only.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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