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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04835649
Other study ID # 1- PD- UE-Telerehabilitation
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2021
Est. completion date May 25, 2022

Study information

Verified date May 2022
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 25, 2022
Est. primary completion date May 15, 2022
Accepts healthy volunteers No
Gender All
Age group 45 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Both groups will receive exercise-based training

Locations

Country Name City State
Turkey Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Manual dexterity performance - Baseline Nine Hole Peg test (9-HPT) Assessment will be conducted before the intervention
Primary Manual dexterity performance - Post intervention Nine Hole Peg test (9-HPT) Assessment will be conducted immediately after the intervention
Primary Finger and hand function - Baseline Jebsen-Taylor Hand Function Test (JTHFT) Assessment will be conducted before the intervention
Primary Finger and hand function - Post intervention Jebsen-Taylor Hand Function Test (JTHFT) Assessment will be conducted immediately after the intervention
Primary Upper extremity performance (coordination, dexterity and functioning) - Baseline Action Research Arm Test (ARAT) Assessment will be conducted before the intervention
Primary Upper extremity performance (coordination, dexterity and functioning) - Post intervention Action Research Arm Test (ARAT) Assessment will be conducted immediately after the intervention
Secondary Isometric hand strength - Baseline J-Tech ™ Assessment will be conducted before the intervention
Secondary Isometric hand strength - Post intervention J-Tech ™ Assessment will be conducted immediately after the intervention
Secondary Isometric pinch strength - Baseline Baseline® pinch meter Assessment will be conducted before the intervention
Secondary Isometric pinch strength - Post intervention Baseline® pinch meter Assessment will be conducted immediately after the intervention
Secondary 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) Assessment will be conducted before the intervention
Secondary 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) Assessment will be conducted immediately after the intervention
Secondary 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 Assessment will be conducted before the intervention
Secondary 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 Assessment will be conducted immediately after the intervention
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