The Effects of Tele-rehabilitation Interventions in Parkinson's Patients

NCT05187195 | Completed

• 1 other identifier: IUC-2021/48
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's Disease (PD) is the most common neurodegenerative movement disorder. The main motor symptoms of PD are tremor, rigidity, bradykinesia, and postural instability. Current treatments of the disease provide control of motor symptoms but do not change its development. Parkinson's patients should receive regular rehabilitation as part of their treatment. Telerehabilitation (TR) practices and studies examining the effectiveness of these practices are needed in order to reduce the impact of the current pandemic period and environmental and personal causes in accessing rehabilitation services. In this thesis, in order to examine the effects of two different TR methods on physical parameters and activities of daily living in Parkinson's patients, Parkinson's patients who are eligible the inclusion criteria will be randomized according to the row of application and divided into 2 groups. Evaluations to determine the functionality, activities of daily living, falling activity, quality of life and fatigue level will be applied both groups. One group will be applied video exercise program prepared individually via TR system, and the other group will receive an exercise brochure via the TR system and patients will be asked to do the exercises 3 days a week for 8 weeks. Then the initial evaluations will be repeated. It is aimed to increase functional capacity, independence in daily living activities and quality of life, and reduce the number of falls and fatigue levels with exercise training to be applied to people with Parkinson's. Investigators think that present study not only will contribute to the field of TR applications in PD, but also will provide access to rehabilitation services and help control symptoms of Parkinson's patients who cannot go to hospital, rehabilitation centers and cannot access rehabilitation services at home. Hypotheses: H0-TR applications have no effect on the level of independence in physical parameters and activities of daily living in individuals with PD. H1-TR applications have positive effects on physical parameters and independence in activities of daily living in individuals with PD.

Conditions

Parkinson Disease

Keywords

Telerehabilitation; Physical Therapy Modalities; Nervous System Diseases; Home-based; Physiotherapy

Outcome Measures

Primary Outcomes (5)

• Single Leg Stance Test - SLS (The change between the initial value and value after 2 months will be evaluated)

  It is a functional assessment test that measures the patient's standing balance on one leg. It is applied for both legs of the patient with eyes open and closed. In Parkinson's disease, standing for less than 10 seconds is associated with balance problems and the risk of falling. Standing for a long time indicates better function. The test maintains for a maximum of 1 minute.

  Baseline and end of weeks 8

• Five Times Sit to Stance Test - 5XSST (The change between the initial value and value after 2 months will be evaluated)

  This test assesses functional lower extremity strength, transfer, balance, and fall risk. The time the patient sits and stands up from the chair 5 time is recorded. Lasting longer than 16 seconds is associated with the risk of falling in Parkinson's patients. Completing the movement in less time indicates better function.

  Baseline and end of weeks 8

• Romberg Test - RT (The change between the initial value and value after 2 months will be evaluated)

  The patient's standing time is recorded in an upright position with her feet open at shoulder level and arms free at the side of the body, with her eyes open and then closed, without losing her balance. If the patient cannot stand with his eyes closed, the test is considered positive, and if the patient can stand with his eyes closed, the test is considered negative. The test is continued for a maximum of 60 seconds. Being able to stand longer indicates better function.

  Baseline and end of weeks 8

• Independent Standing Test (The change between the initial value and value after 2 months will be evaluated)

  It tests the patient's ability to stand in an upright position without any support or assistance, with her feet shoulder width apart and arms free at the side of the body. The patient is expected to be able to stand for 20 seconds. Being able to stand longer indicates better function.

  Baseline and end of weeks 8

• Katz Index of Independence in Activities on Daily Living (The change between the initial value and value after 2 months will be evaluated)

  It is a scale that measures the patient's ability to perform activities of daily living independently and evaluates the functional status. The patient can get a minimum of 0 points and a maximum of 7 points. Higher score indicates better status.

  Baseline and end of weeks 8

Secondary Outcomes (5)

• Modified Falls Efficacy Scale (The change between the initial value and value after 2 months will be evaluated)

  Baseline and end of weeks 8

• The World Health Organization Quality of Life Instrument, Short Form, Turkish Version (WHOQOL-BREF-TR) (The change between the initial value and value after 2 months will be evaluated)

  Baseline and end of weeks 8

• Fatigue Severity Scale (The change between the initial value and value after 2 months will be evaluated)

  Baseline and end of weeks 8

• Global Rating of Change Scales

  End of weeks 8

• System Usability Scale

  End of weeks 8

Study Arms (2)

Telerehabilitation-video group

EXPERIMENTAL

This group will perform their exercises with prepared personalized exercise videos through the telerehabilitation system 3 days a week for 8 weeks.

Other: Home-based telerehabilitation with exercise videos

Telerehabilitation-brochure group

EXPERIMENTAL

This group will perform exercises with personalized exercise brochures defined through the telerehabilitation system 3 days a week for 8 weeks.

Other: Exercise brochure

Interventions

Home-based telerehabilitation with exercise videos OTHER

Balance, walking, strengthening, posture videos etc. taken in different positions will be uploaded to the telerehabilitation system. A personalized exercise program will be created from these exercises. This program will be defined to the account of the patient and the follow-up of the person will be carried out through the system.

Telerehabilitation-video group

Exercise brochure OTHER

Photos and explanations of exercises taken in different positions such as balance, walking, strengthening, posture etc. will be uploaded to the telerehabilitation system. A personalized exercise brochure will be created from these exercises. This program will be defined for the patient's account and the patient will be asked to follow the exercises with this brochure.

Telerehabilitation-brochure group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having been diagnosed with Parkinson's disease at least 1 year ago by a neurologist
• Hoehn and Yahr score ≤3
• Have an internet infrastructure where the system can be accessed at home
• Not participating in a standardized physiotherapy program in the last 3 months

You may not qualify if:

• Presence of blurred or low vision problems
• Hearing and speech impairment affecting participation in the system
• Epilepsy
• Presence of pregnancy
• Having any cognitive problems that prevent using the system

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İstanbul University-Cerrahpasa

Istanbul, Buyukcekmece, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease; Nervous System Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Elif Yılmaz, M.Sc

  Istanbul University- Cerrahpasa Institute of Postgraduate Education

  PRINCIPAL INVESTIGATOR

• Yonca Zenginler Yazgan, PhD

  Istanbul University- Cerrahpasa Faculty of Health Science

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 11, 2022
• Study Start: November 14, 2021
• Primary Completion: November 18, 2022
• Study Completion: February 17, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

TU (1)