The Effect of Upper Extremity Telerehabilitation on Balance and Gait

July 25, 2024 updated by: Sefa Eldemir, Gazi University

The Effect of Upper Extremity Telerehabilitation on Balance and Gait in Parkinson's Patients

Parkinson's Disease (PD) is a disease that affects the upper extremity functional skills with clinical findings such as bradykinesia, rigidity, and hypokinesia and causes limitations in the daily living activities of the patients. The influence of fine dexterity, reaching, and grasping movements greatly affects the daily living activities of the patients. Medical treatment and surgical approaches are frequently used among the treatment options for PD today. Physiotherapy and rehabilitation approaches for progressive functional loss in PD, together with optimal medical and surgical treatment, form the basis of PD treatment. Recently, it has been stated that intensive and task-specific rehabilitation interventions in the field of physiotherapy and rehabilitation will be more effective than traditional rehabilitation approaches. On the other hand, telerehabilitation approaches, the use of which has increased rapidly due to technological developments in recent times, enables the delivery of rehabilitation services to patients in distant places by using communication technologies. For this purpose, it is highly valuable to implement a task-oriented training (TOT) program based on motor learning-based principles, which consists of intense exercise content, through telerehabilitation. Although there are very few studies investigating the effectiveness of telerehabilitation-based TOT in PD, these studies have shown that upper extremity motor performance, activities of daily living, and quality of life are improved. On the other hand, no study has been found showing the effect of upper extremity TOT applied through telerehabilitation on balance and walking. Therefore, there is a need to investigate the effectiveness of telerehabilitation-based TOT exercises on balance and walking.

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 exercise and control. Balance and walking exercises consisting of 3 days a week for 6 weeks will be given to both groups as a home program. In addition, the exercise group will receive Task-oriented Training (TOT) based telerehabilitation via video conferencing 3 days a week for 6 weeks. TOT will be formed from daily life activities such as reaching out, grasping, writing, and manual skills, which are frequently used in daily life. As the outcome measures, disease severity, and disability, balance, and gait 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.
15

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
      • Sivas, Turkey
        • Sivas Cumhuriyet 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 40- 80 years of age
  • Having diagnosed with "Parkinson's Disease" by a specialist physician
  • Having between 1-3 stages according to the Hoehn and Yahr Scale
  • Mini-Mental Test score more than or equal 24

Exclusion Criteria:

- Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results

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: Prevention
  • 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: Telerehabilitation group
In addition to the exercise program consisting of balance and walking activities, the group will receive task-oriented upper extremity training via telerehabilitation accompanied by a physiotherapist.
Other: Telerehabilitation Group
The group that will receive upper extremity training via telerehabilitation in addition to an exercise program consisting of balance and walking activities
Experimental: Control group
The group that will receive a home exercise program consisting of only balance and walking activities
Other: Control Group
The group that will receive an exercise program consisting of balance and walking activities

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
Static Balance- Baseline
Time Frame: Assessment will be conducted before the intervention
Assessment will be made with a Biodex Balance System
Assessment will be conducted before the intervention
Static Balance- Post intervention
Time Frame: Assessment will be conducted immediately after the intervention
Assessment will be made with a Biodex Balance System
Assessment will be conducted immediately after the intervention
Balance- Baseline
Time Frame: Assessment will be conducted before the intervention
Assessment will be made with the Berg Balance Scale
Assessment will be conducted before the intervention
Balance- Post intervention
Time Frame: Assessment will be conducted immediately after the intervention
Assessment will be made with the Berg Balance Scale
Assessment will be conducted immediately after the intervention
Gait- Baseline
Time Frame: Assessment will be conducted before the intervention
Assessment will be made with the Time up and Go Test
Assessment will be conducted before the intervention
Gait- Post intervention
Time Frame: Assessment will be conducted immediately after the intervention
Assessment will be made with the Time up and Go Test
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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cumhuriyet University

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.

General Publications

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.
July 25, 2023

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.
May 10, 2024

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.
June 10, 2024

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).
July 25, 2023

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.
July 25, 2023

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.
August 2, 2023

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 26, 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.
July 25, 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.
July 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.
  • 6- PD-Balance-Telereh-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share 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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