Clinical trial NCT05187195: The Effects of Tele-rehabilitation Interventions in Parkinson's Patients
Official title: The Effects of Two Different Tele-rehabilitation Interventions on Physical Parameters and Activities of Daily Living in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Telerehabilitation
Physical Therapy Modalities
Nervous System Diseases
Home-based
Physiotherapy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 21
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Single Leg Stance Test - SLS (The change between the initial value and value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: Five Times Sit to Stance Test - 5XSST (The change between the initial value and value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: Romberg Test - RT (The change between the initial value and value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: Independent Standing Test (The change between the initial value and value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: Katz Index of Independence in Activities on Daily Living (The change between the initial value and value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
Secondary outcomes:
measure: Modified Falls Efficacy Scale (The change between the initial value and value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: 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)
timeFrame: Baseline and end of weeks 8
measure: Fatigue Severity Scale (The change between the initial value and value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: Global Rating of Change Scales
timeFrame: End of weeks 8
measure: System Usability Scale
timeFrame: End of weeks 8
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul University-Cerrahpasa
state: Buyukcekmece
Study officials:
affiliation: Istanbul University- Cerrahpasa Institute of Postgraduate Education
name: Elif Yılmaz, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University- Cerrahpasa Faculty of Health Science
name: Yonca Zenginler Yazgan, PhD
role: STUDY_CHAIR
References: