- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05897762
The Effects of Telerehabilitation in Chronic Hemiplegic Patients
June 1, 2023 updated by: Hacer Karakurt, Hasan Kalyoncu University
The Effects of Telerehabilitation on Upper Extremity Functions and Activities of Daily Living in Chronic Hemiplegic Patients
The present study was conducted to investigate the effects of telerehabilitation on upper extremity functions and activities of daily living in chronic hemiplegic patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A total of 40 chronic hemiplegic subjects were included in the study.
The patients were divided into 2 groups by simple randomization method.
As the Telerehabilitation Group (TR), Group 1 completed the treatment program, which included upper extremity and lower extremity strengthening exercises, for eight weeks, three days a week for 45-60 minutes, 10 repetitions, with online supervision.
Group 2 was planned as a face-to-face training group and the same exercises were performed in the clinical setting, accompanied by a physiotherapist.
The evaluations were made before and after the treatment.
The Modified Ashworth Scale was used for upper extremity spasticity evaluation.
The Wolf Motor Function Test was used to evaluate upper extremity functionality.
The Barthel ADL Index was used to evaluate Activities of Daily Living (ADL).
The Brunnstrom Staging Survey was used to evaluate the level of motor recovery.
The Treatment Satisfaction Inquiry Survey was used to evaluate the satisfaction of the patients with the treatment method.
Heart Rate (HR) values and oxygen saturation (SaO2) were measured with Pulse Oximetry to monitor vital signs.
Study Type
Interventional
Enrollment (Actual)
40
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 Locations
-
-
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Gaziantep, Turkey, 27010
- Hasan Kalyoncu University
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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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Having been diagnosed with stroke between the ages of 40-70
- It has been 12 months since the stroke
- Individuals with upper extremity spasticity level (Modified Ashworth Scale (MAS) score ≤ 3)
- Hand and upper extremity values above 3 according to Brunnstrom motor staging
- Individuals with ischemic, middle cerebral artery involvement will be taken.
Exclusion Criteria:
- Having advanced apraxia and aphasia
- Patients who do not have the cooperation to perform verbal commands and exercise training
- Patients who have undergone any botulinum toxin application in the last 6 months
- Patients with significant visual and hearing loss
- Individuals who do not have the necessary technological competence to provide remote video communication at home will not be accepted.
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Clinic Grup
the same exercises were performed in the clinical setting, accompanied by a physiotherapist.
The evaluations were made before and after the treatment.
|
It has been determined that the telerehabilitation method applied in chronic hemiplegic patients increases daily living activities, upper extremity functionality, and spasticity levels decrease.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
spasticity levels
Time Frame: Pre-Treatment and post treatment evaluations will ve recorded. (8 Weeks periods)
|
Spasticty will ve evaluated with Modifiye Ashworth Scale
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Pre-Treatment and post treatment evaluations will ve recorded. (8 Weeks periods)
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Upper Extremity functionality
Time Frame: Pre-Treatment and post treatment evaluations will ve recorded. (8 Weeks periods)
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Upper extremity functionality evaluated with DASH
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Pre-Treatment and post treatment evaluations will ve recorded. (8 Weeks periods)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Deniz Kocamaz, Assist Prof, Hasan Kalyoncu University
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)
January 1, 2021
Primary Completion (Actual)
June 1, 2021
Study Completion (Actual)
January 1, 2022
Study Registration Dates
First Submitted
February 4, 2023
First Submitted That Met QC Criteria
June 1, 2023
First Posted (Actual)
June 9, 2023
Study Record Updates
Last Update Posted (Actual)
June 9, 2023
Last Update Submitted That Met QC Criteria
June 1, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HasanKU"
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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