NCT04982887

Brief Summary

Parkinson's disease (PD) is a neurodegenerative disease that occurs with the effect of dopaminergic pathways in the substantia nigra and causes a progressive decrease in motor functions. When the literature is examined; Physiotherapy and rehabilitation programs applied in PD include conventional physiotherapy methods and neurophysiological based activity training. Classical physiotherapy programs; It includes stretching, strengthening, aerobics, posture exercises, balance and coordination training. PH treatment in recent years; Virtual reality is gradually enriched with motor imagery and robot-assisted physiotherapy applications and different exercise methods including dance, music therapy, yoga, pilates and spinal stabilization exercises. Stabilization exercises, which form the basis of spinal stabilization training, use the basic principles of motor learning. The aim of the spinal stabilization exercise program is to support the vertebral column by increasing the strength and endurance of the stabilizer muscles, to improve the spinal posture by increasing kinesthetic awareness and to improve balance control. The COVID-19 pandemic has highlighted the importance of telerehabilitation practices even more. Telerehabilitation can be defined as providing rehabilitation services remotely using information and communication technologies. In order to minimize the risk of transmission in the COVID-19 pandemic, physical activity levels of individuals have been reduced by restricting social life and the access of sick individuals to rehabilitation services is severely restricted. In addition, rehabilitation professionals are at risk in the treatment of these patients due to the serious transmission risk of COVID-19. Considering these situations, it is emphasized by many authorities that telerehabilitation practices should be expanded. Inactivity, which occurs as a result of restrictions in access to social isolation and rehabilitation services, brought about by the COVID-19 Pandemic in Parkinson's patients, adversely affects the progression of the disease. Telerehabilitation allows patients who cannot access rehabilitation due to their geographical, economic or physical disabilities to benefit from rehabilitation services. It is known that telerehabilitation applied in various neurological diseases reduces the fatigue levels of the patients, improves their functional activities and quality of life. In line with all these reasons, this study was planned to investigate the effectiveness of two different exercise programs adapted to the telerehabilitation program in Parkinson's patients during the Covid 19 pandemic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 9, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

May 9, 2021

Last Update Submit

May 24, 2022

Conditions

Keywords

Tele Rehabilitation, Parkinson's Disease

Outcome Measures

Primary Outcomes (10)

  • Unified Parkinson's Disease Rating Scale

    Unified Parkinson's Disease Rating Scale. There are 4 sub-parameters. 1. mental status, behavior and mental state 2. daily life activities 3. motor inspection 4. treatment complications. mental status, behavior and mental state total 16 points, daily activity total 52 points, Motor parameter total 92 points, treatment complications total 23 points. Total maximum 183 points. the total score is calculated by adding all sub-parameter scores. low value is good, high value is a symptom of bad result.

    baseline to 6 week after

  • Numeric Analog Scale

    Numerical rating scale of pain intensity. 0 to 10 is a scale with a rating. 0 points no pain 10 points is a scale with very severe pain. The participant is asked to say a value in this range according to the severity of pain.

    baseline to 6 week after

  • 30 - Second Chair Stand Test

    It is used to assess individuals' lower extremity strength and static balance. the individual is asked to sit and stand in a chair for 30 seconds.

    baseline to 6 week after

  • Static Standing Balance Test

    Individuals were asked to stand in different positions and their static balance was assessed.

    baseline to 6 week after

  • The Fear of Covid-19 Scale

    It is a test that measures individual's Covid-19 fears. Min:7 Max:35 "high score is bad score."

    baseline to 6 week after

  • Short-Form 36

    SF-36 (Short Form 36). Quality of life survey. examines 8 dimensions of health with 36 items. physical function, social function, role restrictions, mental health, vitality, pain and general health. The scores of each parameter are between 0 and 100. 0 bad, 100 good results. is calculated by taking the values of the sub-parameters.

    baseline to 6 week after

  • Beck Anxiety Inventory

    Assesses anxiety level. Min:0 Max:63 "high score is bad score."

    baseline to 6 week after

  • The Beck Depression Inventory

    Assesses the level of depression. Min:0 Max: 63 "high score is bad score."

    baseline to 6 week after

  • ACTIVLIM Scale

    It is a questionnaire that measures the activity limitation of individuals. Min: 0 Max:36 "high score is good score."

    baseline to 6 week after

  • Standardized Mini Mental Test

    Evaluates the cognitive level of the person

    baseline to 6 week after

Study Arms (2)

Experimental Group

EXPERIMENTAL
Other: Exercise

Control Group

EXPERIMENTAL
Other: Exercise

Interventions

The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors. Studies have shown that many position sense proprioceptors are over the deep group cervical muscles such as longus colitis and longus capitis. The deep group cervical muscles, which perform a dynamic ligament function, have an important role in maintaining the stability of the spine as well as the proprioceptive sense. In particular, proprioceptive receptors, which are commonly found in the deep suboccipital muscles; There are cervical and reflex connections with vestibular, visual and postural control systems.

Also known as: Exercise (Servical Stabilization exercises and conventional exercise)
Control GroupExperimental Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals diagnosed with Parkinson's Disease who came to Hacettepe University between December 2018 and July 2019 were included in the thesis study.
  • Individuals who received physiotherapy training two years ago will be contacted by phone and invited to study.
  • On these dates, among the individuals selected within the scope of the thesis study, those who agree to participate in the study will be included in the study.

You may not qualify if:

  • Persons not meeting the above criteria were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Rumeli University

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • Bennett SE, Karnes JL. Neurological Disabilities. Assessment and Treatment. 1 st ed. Lippincott: Philadelphia; 1998.

    BACKGROUND
  • Doherty KM, van de Warrenburg BP, Peralta MC, Silveira-Moriyama L, Azulay JP, Gershanik OS, Bloem BR. Postural deformities in Parkinson's disease. Lancet Neurol. 2011 Jun;10(6):538-49. doi: 10.1016/S1474-4422(11)70067-9. Epub 2011 Apr 22.

    PMID: 21514890BACKGROUND
  • Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.

    PMID: 18344392BACKGROUND
  • Vaugoyeau M, Viel S, Amblard B, Azulay JP, Assaiante C. Proprioceptive contribution of postural control as assessed from very slow oscillations of the support in healthy humans. Gait Posture. 2008 Feb;27(2):294-302. doi: 10.1016/j.gaitpost.2007.04.003. Epub 2007 May 16.

    PMID: 17509884BACKGROUND
  • Bloem BR, Beckley DJ, van Dijk JG, Zwinderman AH, Remler MP, Roos RA. Influence of dopaminergic medication on automatic postural responses and balance impairment in Parkinson's disease. Mov Disord. 1996 Sep;11(5):509-21. doi: 10.1002/mds.870110506.

    PMID: 8866492BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ozden BASKAN

    Istanbul Rumeli University

    STUDY DIRECTOR

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
Specialist Physiotherapist / Research Assistant

Study Record Dates

First Submitted

May 9, 2021

First Posted

July 29, 2021

Study Start

May 8, 2021

Primary Completion

March 25, 2022

Study Completion

April 20, 2022

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Locations