- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04835649
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
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
Interventional
Enrollment (Actual)
30
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise group
The group that will receive task-oriented training via telerehabilitation
|
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
|
Both groups will receive exercise-based training
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
April 15, 2021
Primary Completion (Actual)
May 15, 2022
Study Completion (Actual)
May 25, 2022
Study Registration Dates
First Submitted
March 30, 2021
First Submitted That Met QC Criteria
April 6, 2021
First Posted (Actual)
April 8, 2021
Study Record Updates
Last Update Posted (Actual)
May 27, 2022
Last Update Submitted That Met QC Criteria
May 25, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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