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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Telerehabilitation, Task-oriented, upper extremity

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exercise group

Control group

Arm Description

The group that will receive task-oriented training via telerehabilitation

The control group only will be given a home program that includes walking and balance exercises

Outcomes

Primary Outcome Measures

Manual dexterity performance - Baseline
Nine Hole Peg test (9-HPT)
Manual dexterity performance - Post intervention
Nine Hole Peg test (9-HPT)
Finger and hand function - Baseline
Jebsen-Taylor Hand Function Test (JTHFT)
Finger and hand function - Post intervention
Jebsen-Taylor Hand Function Test (JTHFT)
Upper extremity performance (coordination, dexterity and functioning) - Baseline
Action Research Arm Test (ARAT)
Upper extremity performance (coordination, dexterity and functioning) - Post intervention
Action Research Arm Test (ARAT)

Secondary Outcome Measures

Isometric hand strength - Baseline
J-Tech ™
Isometric hand strength - Post intervention
J-Tech ™
Isometric pinch strength - Baseline
Baseline® pinch meter
Isometric pinch strength - Post intervention
Baseline® pinch meter
Disease severity and disability - Baseline
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)
Disease severity and disability - Post 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)
Health-related Quality of Life - Baseline
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
Health-related Quality of Life - Post 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

Full Information

First Posted
March 30, 2021
Last Updated
May 25, 2022
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04835649
Brief Title
The Effectiveness of Telerehabilitation in Improving Upper Extremity in Parkinson's Patients
Official Title
The Effectiveness of Task-Oriented Training Based Telerehabilitation in Improving Upper Extremity Motor Function in Parkinson's Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Telerehabilitation, Task-oriented, upper extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups as exercise group and control group
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
The group that will receive task-oriented training via telerehabilitation
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The control group only will be given a home program that includes walking and balance exercises
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Both groups will receive exercise-based training
Primary Outcome Measure Information:
Title
Manual dexterity performance - Baseline
Description
Nine Hole Peg test (9-HPT)
Time Frame
Assessment will be conducted before the intervention
Title
Manual dexterity performance - Post intervention
Description
Nine Hole Peg test (9-HPT)
Time Frame
Assessment will be conducted immediately after the intervention
Title
Finger and hand function - Baseline
Description
Jebsen-Taylor Hand Function Test (JTHFT)
Time Frame
Assessment will be conducted before the intervention
Title
Finger and hand function - Post intervention
Description
Jebsen-Taylor Hand Function Test (JTHFT)
Time Frame
Assessment will be conducted immediately after the intervention
Title
Upper extremity performance (coordination, dexterity and functioning) - Baseline
Description
Action Research Arm Test (ARAT)
Time Frame
Assessment will be conducted before the intervention
Title
Upper extremity performance (coordination, dexterity and functioning) - Post intervention
Description
Action Research Arm Test (ARAT)
Time Frame
Assessment will be conducted immediately after the intervention
Secondary Outcome Measure Information:
Title
Isometric hand strength - Baseline
Description
J-Tech ™
Time Frame
Assessment will be conducted before the intervention
Title
Isometric hand strength - Post intervention
Description
J-Tech ™
Time Frame
Assessment will be conducted immediately after the intervention
Title
Isometric pinch strength - Baseline
Description
Baseline® pinch meter
Time Frame
Assessment will be conducted before the intervention
Title
Isometric pinch strength - Post intervention
Description
Baseline® pinch meter
Time Frame
Assessment will be conducted immediately after the intervention
Title
Disease severity and disability - Baseline
Description
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)
Time Frame
Assessment will be conducted before the intervention
Title
Disease severity and disability - Post intervention
Description
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)
Time Frame
Assessment will be conducted immediately after the intervention
Title
Health-related Quality of Life - Baseline
Description
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
Time Frame
Assessment will be conducted before the intervention
Title
Health-related Quality of Life - Post intervention
Description
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
Time Frame
Assessment will be conducted immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sefa Eldemir, PT, MSc.
Organizational Affiliation
Research Assistant
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Arzu Güçlü-Gündüz, PT, PhD.
Organizational Affiliation
Professor
Official's Role
Study Director
Facility Information:
Facility Name
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/28578819/
Description
Related info
URL
https://pubmed.ncbi.nlm.nih.gov/32117009/
Description
Related info

Learn more about this trial

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

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