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The Effectiveness of Telerehabilitation in Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Home program
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Telerehabilitation, modified-Constraint Induced Movement Therapy, Upper Extremity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-65 years of age
  • Being diagnosed with stroke for the first time by a doctor
  • Having been diagnosed with stroke at least 1 month ago
  • Mini-Mental Test Score more than or equal 24
  • In the upper extremities; Starting from the angle of full flexion, wrist extension of at least 20° or more, thumb extension or abduction of at least 10°, minimum extension of all other fingers at the metacarpophalangeal and interphalangeal joints
  • Having less than 2.5 points in the pre-treatment evaluation from both parts of MAG-28
  • Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary.
  • Absence of severe pain to affect the treatment
  • Absence of severe spasticity to affect the treatment (spasticity in any joint of the upper extremity ≤ 2 according to the Modified Ashworth Scale)

Exclusion Criteria:

  • Any orthopedic, vision, hearing or perception problems that may affect the research results
  • Having an additional neurological, cardiovascular, pulmonary or hormonal disorder that would prevent participation in the study.

Sites / Locations

  • Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Group

Control group

Arm Description

The group will receive modified-Constraint Induced Movement Therapy via telerehabilitation and a home exercise program.

The group only will be given a home exercise program.

Outcomes

Primary Outcome Measures

Upper extremity motor ability-Baseline
Wolf Motor Function Test
Upper extremity motor ability-Post intervention
Wolf Motor Function Test
Upper extremity motor function-Baseline
The Fugl-Meyer Assessment of the Upper Extremity
Upper extremity motor function-Post intervention
The Fugl-Meyer Assessment of the Upper Extremity
Activities of daily living related to the upper extremity-Baseline
Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.
Activities of daily living related to the upper extremity-Post intervention
Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.
Voluntary movement and mobility-Baseline
Stroke Rehabilitation Assessment of Movement (STREAM)
Voluntary movement and mobility-Post intervention
Stroke Rehabilitation Assessment of Movement (STREAM)

Secondary Outcome Measures

Isometric hand strength-Baseline
J-Tech™
Isometric hand strength-Post intervention
J-Tech™
Isometric pinch strength-Baseline
Baseline® pinch meter
Isometric pinch strength-Post intervention
Baseline® pinch meter
manual dexterity performance-Baseline
nine-hole peg test (9-HTP)
manual dexterity performance-Post intervention
nine-hole peg test (9-HTP)
level of independence in activities of daily living-Baseline
Functional Independence Measure
level of independence in activities of daily living-Post intervention
Functional Independence Measure

Full Information

First Posted
October 28, 2021
Last Updated
July 9, 2023
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05128461
Brief Title
The Effectiveness of Telerehabilitation in Stroke Patients
Official Title
The Effectiveness of Modified-Constraint Induced Movement Therapy Based Telerehabilitation in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Stroke, according to the definition of the World Health Organization (WHO); It is a syndrome characterized by a rapid settlement of signs and symptoms of focal loss of cerebral function without a cause other than vascular causes. As it is known, it is important for patients to regain functional skills in the upper extremities after stroke. Modified-Constraint Induced Movement Therapy (m-CIMT) is a versatile neurorehabilitation technique that aims to improve motor function in the hemiparetic upper extremity and increase its use in daily life activities. However, as in the Covid-19 pandemic, patients cannot always reach rehabilitation services. In such cases, telerehabilitation is a treatment option. There are a limited number of studies in which m-CIMT is applied according to the principle of telerehabilitation, which has become a necessity, especially due to the Covid-19 pandemic. Therefore, the aim of this study is to examine the effects of m-CIMT on upper extremity motor functions in stroke patients.
Detailed Description
This study is a randomized controlled study. The patients will be randomly divided into two groups as exercise and control. Patients in both groups will be given lower-upper extremity exercises and gait training exercises selected according to the Bobath approach as a home program consisting of 10 exercises to be applied 5 days a week for 3 weeks. All patients will perform the same exercises. In addition, the exercise group will receive Modified-Constraint Induced Movement Therapy (m-CIMT) based telerehabilitation via video conferencing 5 days a week for 3 weeks. Patients in the m-CIMT group will be asked to restrict the movements of their less affected hands by using mitt for 5 hours a day/ 5 days a week for 3 weeks while the patients are awake. Evaluations for both groups will be made by a physiotherapist blinded to the study twice, at the beginning and 3 weeks later. As outcome measures functional performance, hand strength, activities of daily living and quality of life will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Telerehabilitation, modified-Constraint Induced Movement Therapy, Upper Extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups as exercise group and control group
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
The group will receive modified-Constraint Induced Movement Therapy via telerehabilitation and a home exercise program.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The group only will be given a home exercise program.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
M-CIMT-based telerehabilitation will be implemented.
Intervention Type
Other
Intervention Name(s)
Home program
Intervention Description
Lower and upper extremity exercises and gait training exercises selected according to the Bobath approach will be given as a home program consisting of 10 same exercises.
Primary Outcome Measure Information:
Title
Upper extremity motor ability-Baseline
Description
Wolf Motor Function Test
Time Frame
Assessment will be conducted before the intervention.
Title
Upper extremity motor ability-Post intervention
Description
Wolf Motor Function Test
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Upper extremity motor function-Baseline
Description
The Fugl-Meyer Assessment of the Upper Extremity
Time Frame
Assessment will be conducted before the intervention.
Title
Upper extremity motor function-Post intervention
Description
The Fugl-Meyer Assessment of the Upper Extremity
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Activities of daily living related to the upper extremity-Baseline
Description
Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.
Time Frame
Assessment will be conducted before the intervention.
Title
Activities of daily living related to the upper extremity-Post intervention
Description
Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Voluntary movement and mobility-Baseline
Description
Stroke Rehabilitation Assessment of Movement (STREAM)
Time Frame
Assessment will be conducted before the intervention.
Title
Voluntary movement and mobility-Post intervention
Description
Stroke Rehabilitation Assessment of Movement (STREAM)
Time Frame
Assessment will be conducted immediately after the intervention.
Secondary Outcome Measure Information:
Title
Isometric hand strength-Baseline
Description
J-Tech™
Time Frame
Assessment will be conducted before the intervention.
Title
Isometric hand strength-Post intervention
Description
J-Tech™
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Isometric pinch strength-Baseline
Description
Baseline® pinch meter
Time Frame
Assessment will be conducted before the intervention.
Title
Isometric pinch strength-Post intervention
Description
Baseline® pinch meter
Time Frame
Assessment will be conducted immediately after the intervention.
Title
manual dexterity performance-Baseline
Description
nine-hole peg test (9-HTP)
Time Frame
Assessment will be conducted before the intervention.
Title
manual dexterity performance-Post intervention
Description
nine-hole peg test (9-HTP)
Time Frame
Assessment will be conducted immediately after the intervention.
Title
level of independence in activities of daily living-Baseline
Description
Functional Independence Measure
Time Frame
Assessment will be conducted before the intervention.
Title
level of independence in activities of daily living-Post intervention
Description
Functional Independence Measure
Time Frame
Assessment will be conducted immediately after the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years of age Being diagnosed with stroke for the first time by a doctor Having been diagnosed with stroke at least 1 month ago Mini-Mental Test Score more than or equal 24 In the upper extremities; Starting from the angle of full flexion, wrist extension of at least 20° or more, thumb extension or abduction of at least 10°, minimum extension of all other fingers at the metacarpophalangeal and interphalangeal joints Having less than 2.5 points in the pre-treatment evaluation from both parts of MAG-28 Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary. Absence of severe pain to affect the treatment Absence of severe spasticity to affect the treatment (spasticity in any joint of the upper extremity ≤ 2 according to the Modified Ashworth Scale) Exclusion Criteria: Any orthopedic, vision, hearing or perception problems that may affect the research results Having an additional neurological, cardiovascular, pulmonary or hormonal disorder that would prevent participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fettah SAYGILI, PT, M.Sc.
Organizational Affiliation
Research Assistant
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Arzu Güçlü-Gündüz, PT, PhD.
Organizational Affiliation
Professor
Official's Role
Study Director
Facility Information:
Facility Name
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD data but when the statistical analysis of all data is made, all results will be shared.
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7502810/
Description
Related info

Learn more about this trial

The Effectiveness of Telerehabilitation in Stroke Patients

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