The Effectiveness of Telerehabilitation in Stroke Patients

July 9, 2023 updated by: Fettah Saygılı, Gazi University

The Effectiveness of Modified-Constraint Induced Movement Therapy Based Telerehabilitation in Stroke Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise Group
The group will receive modified-Constraint Induced Movement Therapy via telerehabilitation and a home exercise program.
Other: Exercise
M-CIMT-based telerehabilitation will be implemented.
Other: Home program
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.
Active Comparator: Control group
The group only will be given a home exercise program.
Other: Home program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Upper extremity motor ability-Baseline
Time Frame: Assessment will be conducted before the intervention.
Wolf Motor Function Test
Assessment will be conducted before the intervention.
Upper extremity motor ability-Post intervention
Time Frame: Assessment will be conducted immediately after the intervention.
Wolf Motor Function Test
Assessment will be conducted immediately after the intervention.
Upper extremity motor function-Baseline
Time Frame: Assessment will be conducted before the intervention.
The Fugl-Meyer Assessment of the Upper Extremity
Assessment will be conducted before the intervention.
Upper extremity motor function-Post intervention
Time Frame: Assessment will be conducted immediately after the intervention.
The Fugl-Meyer Assessment of the Upper Extremity
Assessment will be conducted immediately after the intervention.
Activities of daily living related to the upper extremity-Baseline
Time Frame: Assessment will be conducted before the 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.
Assessment will be conducted before the intervention.
Activities of daily living related to the upper extremity-Post intervention
Time Frame: Assessment will be conducted immediately after the 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.
Assessment will be conducted immediately after the intervention.
Voluntary movement and mobility-Baseline
Time Frame: Assessment will be conducted before the intervention.
Stroke Rehabilitation Assessment of Movement (STREAM)
Assessment will be conducted before the intervention.
Voluntary movement and mobility-Post intervention
Time Frame: Assessment will be conducted immediately after the intervention.
Stroke Rehabilitation Assessment of Movement (STREAM)
Assessment will be conducted immediately after the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Isometric hand strength-Baseline
Time Frame: Assessment will be conducted before the intervention.
J-Tech™
Assessment will be conducted before the intervention.
Isometric hand strength-Post intervention
Time Frame: Assessment will be conducted immediately after the intervention.
J-Tech™
Assessment will be conducted immediately after the intervention.
Isometric pinch strength-Baseline
Time Frame: Assessment will be conducted before the intervention.
Baseline® pinch meter
Assessment will be conducted before the intervention.
Isometric pinch strength-Post intervention
Time Frame: Assessment will be conducted immediately after the intervention.
Baseline® pinch meter
Assessment will be conducted immediately after the intervention.
manual dexterity performance-Baseline
Time Frame: Assessment will be conducted before the intervention.
nine-hole peg test (9-HTP)
Assessment will be conducted before the intervention.
manual dexterity performance-Post intervention
Time Frame: Assessment will be conducted immediately after the intervention.
nine-hole peg test (9-HTP)
Assessment will be conducted immediately after the intervention.
level of independence in activities of daily living-Baseline
Time Frame: Assessment will be conducted before the intervention.
Functional Independence Measure
Assessment will be conducted before the intervention.
level of independence in activities of daily living-Post intervention
Time Frame: Assessment will be conducted immediately after the intervention.
Functional Independence Measure
Assessment will be conducted immediately after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Arzu Güçlü-Gündüz, PT, PhD., Professor
  • Study Chair: Fettah SAYGILI, PT, M.Sc., Research assistant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-Stroke-CIMT-Telerehab.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

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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