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

Status

Status

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

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

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

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 (Estimated)

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.
40

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 Contact Backup

Study Locations

  • Turkey
    • Merkez
      • Isparta, Merkez, Turkey
        • Recruiting
        • Suleyman Demirel University
        • Contact:
    • İ̇zmi̇t
      • Kocaeli, İ̇zmi̇t, Turkey
        • Recruiting
        • Güler Ertuğrul
        • Contact:

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

  • 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

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.
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.
Other: control + 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 in 5 sessions per week for 6 weeks.

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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suleyman Demirel 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)

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.
February 8, 2024

Primary Completion (Estimated)

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.
February 27, 2025

Study Completion (Estimated)

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.
November 27, 2025

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).
February 8, 2024

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.
February 8, 2024

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.
February 15, 2024

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.
February 15, 2024

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.
February 8, 2024

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.
February 1, 2024

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.
  • 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings