NCT05621642

Brief Summary

Parkinson's disease (PD) is the second most common progressive disease after Alzheimer's disease.It is a progressive, multisystemic and neurodegenerative disease. The prevalence of Parkinson's disease increases with age. increases together. In industrialized countries, people over the age of 60 account for 0.3% of the entire population.It affects about 1% of people and 3% of people over the age of 80 .Patient management with telerehabilitation (TR), chronic heart disease, neurological dysfunction.It is as effective as face-to-face treatment in different clinical conditions such as musculoskeletal and musculoskeletal disorders proven . In addition, TR will increase accessibility and create a less restrictive environment. comparable to traditional rehabilitation as it provides new opportunities to create not only can it be more effective than it . Intense exercise and long-term training In cases where it is necessary, it is accepted to continue exercise therapy with TR programs at home.may be a viable solution.When telerehabilitation-based studies are examined, communication, swallowing and walking are generally focused on parameters. Treatment with telerehabilitation method in PD, Studies investigating the effects on respiratory and postural instability parameters are quite is limited . The aim of this study is to improve telerehabilitation-based exercise training in PD. respiratory muscle strength, cough capacity, dynamic balance, participation in activities of daily living and to investigate its effect on walking parameters. also online physiotherapist.Comparing the effects of supervised exercises and offline video-based exercise training intended.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable parkinson-disease

Status
unknown

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

First Submitted

Initial submission to the registry

October 28, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

November 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2023

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

October 28, 2022

Last Update Submit

November 14, 2022

Conditions

Keywords

telerehabilitationbalanceparkinson

Outcome Measures

Primary Outcomes (3)

  • Timed up and go test

    In the timed up and go test, subjects are asked to rise from a standard arm chair, walk to a marker 3 m away, turn, walk back, and sit down again. The test is a reliable and valid test for quantifying functional mobility that may also be useful in following clinical change over time.

    3 minute

  • Respiratory Strength Assesment

    MIP and MEP value will be measured.

    3 minute

  • Peak Cough Stream Assesment

    Changed motor control of cough as there is a change in force production using the expiratory muscles

    3 minute

Secondary Outcomes (4)

  • Tinetti balance Test

    5 minute

  • 10 m Walking Test

    3 minute

  • Parkinson's Activity Scale Parkinson Activity Test

    5 minute

  • Unified Parkinson's Disease Rating Scale

    5 minute

Study Arms (2)

Online Group

EXPERIMENTAL

Trainings will be given to the intervention group patients by the researchers. Respiratory, balance and strengthening exercises suitable for the patients will be applied over an online platform under the supervision of a physiotherapist.

Other: Breathing exercisesOther: Core stabilization exercisesOther: Balance and strengthening exercises

Offline Group

ACTIVE COMPARATOR

The exercises will be video recorded gradually every two weeks and the exercise program of each week will be sent to the patient. The patient will do respiratory, balance and strengthening exercises accompanied by video.

Other: Breathing exercisesOther: Core stabilization exercisesOther: Balance and strengthening exercises

Interventions

In the sitting position, the patient does 15 diaphragm breathing and 15 huffing exercises.

Offline GroupOnline Group

This intervention includes bridging exercise and abdominal exercises.

Offline GroupOnline Group

It includes sitting and standing on the chair 15 times and turning around the chair.

Offline GroupOnline Group

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having been diagnosed with PH by a neurologist,
  • Being between 45 and 85 years old,
  • Being between I and III according to the modified Hoehn \& Yahr Staging (29)
  • To have a score of 24 or higher in the Mini Mental State Assessment (30),
  • To be taking their medication regularly.

You may not qualify if:

  • Having an orthopedic disability that will affect balance and mobility,
  • Those with serious chronic diseases that will significantly affect their quality of life (congestive heart failure, myocardial infarction),
  • Severe dyskinesia, cognitive problem that prevents cooperation,
  • Not having internet access with a smart phone or computer,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Lee A, Gilbert RM. Epidemiology of Parkinson Disease. Neurol Clin. 2016 Nov;34(4):955-965. doi: 10.1016/j.ncl.2016.06.012. Epub 2016 Aug 18.

    PMID: 27720003BACKGROUND
  • Peretti A, Amenta F, Tayebati SK, Nittari G, Mahdi SS. Telerehabilitation: Review of the State-of-the-Art and Areas of Application. JMIR Rehabil Assist Technol. 2017 Jul 21;4(2):e7. doi: 10.2196/rehab.7511.

    PMID: 28733271BACKGROUND
  • McCue M, Fairman A, Pramuka M. Enhancing quality of life through telerehabilitation. Phys Med Rehabil Clin N Am. 2010 Feb;21(1):195-205. doi: 10.1016/j.pmr.2009.07.005.

    PMID: 19951786BACKGROUND
  • Silverman EP, Sapienza CM, Saleem A, Carmichael C, Davenport PW, Hoffman-Ruddy B, Okun MS. Tutorial on maximum inspiratory and expiratory mouth pressures in individuals with idiopathic Parkinson disease (IPD) and the preliminary results of an expiratory muscle strength training program. NeuroRehabilitation. 2006;21(1):71-9.

    PMID: 16720940BACKGROUND
  • Saleem AF, Sapienza CM, Okun MS. Respiratory muscle strength training: treatment and response duration in a patient with early idiopathic Parkinson's disease. NeuroRehabilitation. 2005;20(4):323-33.

    PMID: 16403998BACKGROUND
  • Wirdefeldt K, Adami HO, Cole P, Trichopoulos D, Mandel J. Epidemiology and etiology of Parkinson's disease: a review of the evidence. Eur J Epidemiol. 2011 Jun;26 Suppl 1:S1-58. doi: 10.1007/s10654-011-9581-6. Epub 2011 May 28.

    PMID: 21626386BACKGROUND
  • Van Den Eeden SK, Tanner CM, Bernstein AL, Fross RD, Leimpeter A, Bloch DA, Nelson LM. Incidence of Parkinson's disease: variation by age, gender, and race/ethnicity. Am J Epidemiol. 2003 Jun 1;157(11):1015-22. doi: 10.1093/aje/kwg068.

    PMID: 12777365BACKGROUND
  • Lotankar S, Prabhavalkar KS, Bhatt LK. Biomarkers for Parkinson's Disease: Recent Advancement. Neurosci Bull. 2017 Oct;33(5):585-597. doi: 10.1007/s12264-017-0183-5. Epub 2017 Sep 21.

    PMID: 28936761BACKGROUND
  • Kim Y, Lai B, Mehta T, Thirumalai M, Padalabalanarayanan S, Rimmer JH, Motl RW. Exercise Training Guidelines for Multiple Sclerosis, Stroke, and Parkinson Disease: Rapid Review and Synthesis. Am J Phys Med Rehabil. 2019 Jul;98(7):613-621. doi: 10.1097/PHM.0000000000001174.

    PMID: 30844920BACKGROUND
  • Cheng DK, Nelson M, Brooks D, Salbach NM. Validation of stroke-specific protocols for the 10-meter walk test and 6-minute walk test conducted using 15-meter and 30-meter walkways. Top Stroke Rehabil. 2020 May;27(4):251-261. doi: 10.1080/10749357.2019.1691815. Epub 2019 Nov 21.

    PMID: 31752634BACKGROUND
  • Nieuwboer A, De Weerdt W, Dom R, Bogaerts K, Nuyens G. Development of an activity scale for individuals with advanced Parkinson disease: reliability and "on-off" variability. Phys Ther. 2000 Nov;80(11):1087-96.

    PMID: 11046196BACKGROUND
  • Feng H, Li C, Liu J, Wang L, Ma J, Li G, Gan L, Shang X, Wu Z. Virtual Reality Rehabilitation Versus Conventional Physical Therapy for Improving Balance and Gait in Parkinson's Disease Patients: A Randomized Controlled Trial. Med Sci Monit. 2019 Jun 5;25:4186-4192. doi: 10.12659/MSM.916455.

    PMID: 31165721BACKGROUND
  • Soke F, Guclu-Gunduz A, Kocer B, Fidan I, Keskinoglu P. Task-oriented circuit training combined with aerobic training improves motor performance and balance in people with Parkinson's Disease. Acta Neurol Belg. 2021 Apr;121(2):535-543. doi: 10.1007/s13760-019-01247-8. Epub 2019 Nov 18.

    PMID: 31741209BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseRespiratory AspirationGait Disorders, Neurologic

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Tuğba Argün Pulat

    Doctor in hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rüstem Mustafaoğlu

CONTACT

İlknur Mazı

CONTACT

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

October 28, 2022

First Posted

November 18, 2022

Study Start

November 20, 2022

Primary Completion

March 13, 2023

Study Completion

June 5, 2023

Last Updated

November 18, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share