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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06234657
Other study ID # UniversitySHCMC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date June 15, 2024

Study information

Verified date May 2024
Source University of Science Ho Chi Minh City
Contact Doan Nguyen, master
Phone +84392332846
Email doannguyenvltl@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date June 15, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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

Locations

Country Name City State
Vietnam University of Medicine and Pharmacy at Ho Chi Minh City Ho Chi Minh

Sponsors (1)

Lead Sponsor Collaborator
University of Science Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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
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