- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06261099
Telerehabilitation-Based Early Upper Extremity Training in Stroke Patients
February 8, 2024 updated by: Güler ERTUĞRUL, Suleyman Demirel University
The Effect of Telerehabilitation-Based Early Upper Extremity Training on Upper Extremity Function and Proprioception in Stroke Patients
Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years.
Telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic.
Study Overview
Detailed Description
After the sociodemographic data of the participants are recorded, Mini Mental Test (MMT) will be applied to evaluate the cognitive status.
Upper extremity functions of patients eligible for the study will be evaluated with the Fugl-Meyer Upper Extremity Scale (FM-UE), proprioception evaluation will be evaluated with the Laser-pointer Assisted Angle Reproduction Test, activities of daily living will be evaluated with the Modified Barthel Index, and reaching performance will be evaluated with the Reaching Performance Scale.
Characteristics of the patients participating in the study and all outcome measurements before and after treatment will be evaluated by a blinded physiotherapist.
A researcher blinded to the exercise groups and evaluation results will perform the statistical analysis.
Study Type
Interventional
Enrollment (Estimated)
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 Contact
- Name: GÜLER ERTUĞRUL
- Phone Number: +90 531 950 05 90
- Email: gertugrul004@gmail.com
Study Contact Backup
- Name: MEHMET DURAY
- Phone Number: +90 506 473 11 65
- Email: mehmetduray@sdu.edu.tr
Study Locations
-
-
Merkez
-
Isparta, Merkez, Turkey
- Recruiting
- Suleyman Demirel University
-
Contact:
- MEHMET DURAY
- Phone Number: +90 506 473 11 65
- Email: mehmetduray@sdu.edu.tr
-
-
İ̇zmi̇t
-
Kocaeli, İ̇zmi̇t, Turkey
- Recruiting
- Güler Ertuğrul
-
Contact:
- GÜLER ERTUĞRUL
- Phone Number: +90 531 950 05 90
- Email: gertugrul004@gmail.com
-
-
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:
- Between the ages of 30-65, with a history of stroke within the last month,
- Mini Mental Score ≥ 24, 1-10 after discharge. on the day,
- patients who can sit for at least 30 seconds, exhibit a hemiparetic condition, and are clinically stable
Exclusion Criteria:
- Flaccid hemiplegia detected by anamnesis and physical examination,
- Has spasticity in the upper extremity with a severity greater than 1+ according to the Modified Ashworth Scale,
- patients with severe dementia and dysfunction of the upper extremity joints due to a previous musculoskeletal disease
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Exercises including upper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group, 5 sessions per week for 6 weeks.
Since the functional recovery of the upper extremity after stroke will be slow, the exercise program is planned to be 5 days a week due to the necessity of applying an intense exercise program in the early period.
All patients will be asked to perform exercises under the supervision of a physiotherapist as a home program on other days of the week.
|
|
Experimental: kontrol+ working group
Upper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group using the telerehabilitation method, which was applied to the control group in 5 sessions per week for 6 weeks.
The telerehabilitation program will be carried out using an application that provides remote video access called Zoom.
Since the functional recovery of the upper extremity after stroke will be slow, the exercise program is planned to be 5 days a week due to the necessity of applying an intense exercise program in the early period.
All patients will be asked to perform exercises under the supervision of a physiotherapist as a home program on other days of the week.
|
Upper extremity positioning, overhead activity training, reaching activities, weight transfer exercises, proprioceptive exercises, and daily living activities training will be applied to this group using the telerehabilitation method, which was applied to in 5 sessions per week for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini Mental Test
Time Frame: six weeks
|
It is used to evaluate the cognitive status of patients.
It is a simple, short and valid test that is widely used in people with stroke.
With this test, various cognitive functions of people such as orientation, recording memory, attention and calculation, recall and language are evaluated.
The maximum score that can be obtained is 30.
Getting a score of 24 or above indicates that the patient's cognitive functions are within normal limits.
|
six weeks
|
Fugl Meyer Motor Function Scale
Time Frame: six weeks
|
Motor performance is evaluated in stroke patients.
Each item is given a score from 0 to 2, depending on performance: 2 points; complete detailing, 1 point; partial work of details, 0 points; It is given if details cannot be achieved.
The maximum motor performance score for the upper extremity is 66 points.
|
six weeks
|
Laser-pointer Assisted Angle Reproduction Test
Time Frame: six weeks
|
It evaluates proprioceptive deviation in stroke patients.
Shoulder flexion is measured three times at 45◦, 60◦ and 90◦, and upper extremity proprioception is evaluated by taking the average result of the three measurements.
|
six weeks
|
Modified Barthel Index
Time Frame: six weeks
|
Determines the functional adequacy, dependency level and rehabilitation services of stroke patients.
Items on the scale are rated between 0 and 15 points in 5-point increments depending on the question.
0-20 points are considered fully dependent, 21-61 points are considered highly dependent, 62-90 points are considered moderately dependent, 91-99 points are considered mildly dependent, and 100 points are considered fully independent.
|
six weeks
|
Reaching Performance Scale
Time Frame: six weeks
|
It evaluates compensatory movements for upper extremity extension in stroke patients.
Scores on items 1 to 5 are used to identify deficiencies in specific aspects of movement, with scores ranging from 0 to 18 being obtained depending on changing performance.
|
six weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 8, 2024
Primary Completion (Estimated)
February 27, 2025
Study Completion (Estimated)
November 27, 2025
Study Registration Dates
First Submitted
February 8, 2024
First Submitted That Met QC Criteria
February 8, 2024
First Posted (Actual)
February 15, 2024
Study Record Updates
Last Update Posted (Actual)
February 15, 2024
Last Update Submitted That Met QC Criteria
February 8, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 037
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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