The Effectiveness of Telerehabilitation in Improving Upper Extremity in Parkinson's Patients

May 25, 2022 updated by: Sefa Eldemir, Gazi University

The Effectiveness of Task-Oriented Training Based Telerehabilitation in Improving Upper Extremity Motor Function in Parkinson's Patients

Parkinson's Disease (PD) is a disease that affects the functional skills of the upper extremity with clinical findings such as bradykinesia, rigidity, and hypokinesia and causes limitations in the daily life activities of the patients. Task-oriented training (TOT) is a highly individualized, client-centered, occupational therapy, functional-based intervention compatible with motor learning and motor control principles such as intensive motor training, variable practice, and intermittent feedback. Few studies have been found on the TOT of the upper extremity in PD. Telerehabilitation of Parkinson's patients shows many strengths, such as cost-related and time-dependent ease, and the possibility of telecommunication with clinicians. In addition, the refinement of digital health solutions with the goal to offer a patient-tailored intervention remains an ongoing process. There are a limited number of studies on TOT and telerehabilitation of the upper extremity in PD. In addition, no studies have been found applying TOT through telerehabilitation. For this purpose, a study including TOT-based telerehabilitation in upper extremity education in PD was planned.

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. 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 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, finger and hand function, hand strength, 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.
30

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 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

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 45- 70 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: 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 that will receive task-oriented training via telerehabilitation
Other: Exercise
Both groups will receive exercise-based training
Placebo Comparator: Control group
The control group only will be given a home program that includes walking and balance exercises
Other: Exercise
Both groups will receive exercise-based training

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
Manual dexterity performance - Baseline
Time Frame: Assessment will be conducted before the intervention
Nine Hole Peg test (9-HPT)
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-HPT)
Assessment will be conducted immediately after the intervention
Finger and hand function - Baseline
Time Frame: Assessment will be conducted before the intervention
Jebsen-Taylor Hand Function Test (JTHFT)
Assessment will be conducted before the intervention
Finger and hand function - Post intervention
Time Frame: Assessment will be conducted immediately after the intervention
Jebsen-Taylor Hand Function Test (JTHFT)
Assessment will be conducted immediately after the intervention
Upper extremity performance (coordination, dexterity and functioning) - Baseline
Time Frame: Assessment will be conducted before the intervention
Action Research Arm Test (ARAT)
Assessment will be conducted before the intervention
Upper extremity performance (coordination, dexterity and functioning) - Post intervention
Time Frame: Assessment will be conducted immediately after the intervention
Action Research Arm Test (ARAT)
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
Disease severity and disability - Baseline
Time Frame: Assessment will be conducted before the intervention
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS has a maximum score of 272 and is composed of four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications) (UPDRS). (0= best , 272= worst)
Assessment will be conducted before the intervention
Disease severity and disability - Post intervention
Time Frame: Assessment will be conducted immediately after the intervention
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS has a maximum score of 272 and is composed of four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications) (UPDRS). (0= best , 272= worst)
Assessment will be conducted immediately after the intervention
Health-related Quality of Life - Baseline
Time Frame: Assessment will be conducted before the intervention
Parkinson's Disease Questionnaire 8 (PDQ-8). There are 8 questions in total and each question is scored from 0-4 points. High score indicates decreased quality of life
Assessment will be conducted before the intervention
Health-related Quality of Life - Post intervention
Time Frame: Assessment will be conducted immediately after the intervention
Parkinson's Disease Questionnaire 8 (PDQ-8). There are 8 questions in total and each question is scored from 0-4 points. High score indicates decreased quality of life
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 Chair: Sefa Eldemir, PT, MSc., Research assistant
  • Study Director: Arzu Güçlü-Gündüz, PT, PhD., PROFESSOR

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.
April 15, 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.
May 15, 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.
May 25, 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).
March 30, 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.
April 6, 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.
April 8, 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.
May 27, 2022

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.
May 25, 2022

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.
May 1, 2022

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- PD- UE-Telerehabilitation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a 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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