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The Effects of Telerehabilitation in Chronic Hemiplegic Patients

Primary Purpose

Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tele rehabilitation Group
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemiplegia focused on measuring fuctionallity, chronic hemiplegia, Spastisity, Tele-rehabilitation, upper extremity

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hasan Kalyoncu University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Clinic Grup

Arm Description

the same exercises were performed in the clinical setting, accompanied by a physiotherapist. The evaluations were made before and after the treatment.

Outcomes

Primary Outcome Measures

spasticity levels
Spasticty will ve evaluated with Modifiye Ashworth Scale
Upper Extremity functionality
Upper extremity functionality evaluated with DASH

Secondary Outcome Measures

Full Information

First Posted
February 4, 2023
Last Updated
June 1, 2023
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05897762
Brief Title
The Effects of Telerehabilitation in Chronic Hemiplegic Patients
Official Title
The Effects of Telerehabilitation on Upper Extremity Functions and Activities of Daily Living in Chronic Hemiplegic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present study was conducted to investigate the effects of telerehabilitation on upper extremity functions and activities of daily living in chronic hemiplegic patients.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
fuctionallity, chronic hemiplegia, Spastisity, Tele-rehabilitation, upper extremity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinic Grup
Arm Type
Other
Arm Description
the same exercises were performed in the clinical setting, accompanied by a physiotherapist. The evaluations were made before and after the treatment.
Intervention Type
Behavioral
Intervention Name(s)
Tele rehabilitation Group
Intervention Description
It has been determined that the telerehabilitation method applied in chronic hemiplegic patients increases daily living activities, upper extremity functionality, and spasticity levels decrease.
Primary Outcome Measure Information:
Title
spasticity levels
Description
Spasticty will ve evaluated with Modifiye Ashworth Scale
Time Frame
Pre-Treatment and post treatment evaluations will ve recorded. (8 Weeks periods)
Title
Upper Extremity functionality
Description
Upper extremity functionality evaluated with DASH
Time Frame
Pre-Treatment and post treatment evaluations will ve recorded. (8 Weeks periods)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Kocamaz, Assist Prof
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
ZIP/Postal Code
27010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Telerehabilitation in Chronic Hemiplegic Patients

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