NCT07302386

Brief Summary

The aim of this study is to examine the benefits that individuals with Parkinson's disease will gain from the rehabilitation program by enabling them to manage their exercise times independently using telerehabilitation method. The main research questions examined in this study are as follows:

  • Are the improvements in quality of life, walking speed and changes in functionality parameters achieved by individuals with Parkinson's disease through managing their own exercise plans as effective as those achieved through a supervised exercise programme?
  • Is it effective for Parkinson's patients to manage their own exercise plans in improving their adherence to exercise?

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress41%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

December 11, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2026

Expected
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2026

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

December 11, 2025

Last Update Submit

March 30, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • Change in motor impairment

    The Unified Parkinson's Disease Rating Scale (UPDRS) is used to determine the symptoms and clinical severity of PD. The UPDRS-III subscore will be used to assess changes in motor impairment.

    Baseline and the end of the 8 weeks exercise program

  • Change in behavioral regulations in exercise

    Behavioral Regulations in Exercise Questionnaire-2 consists of 19 items and five subscales. The subscales consist of external regulation, internalized regulation, defined regulation, internal regulation and lack of motivation. It is a 5-point Likert-type scale scored between 0-4.

    Baseline and the end of the 8 weeks exercise program

  • Change in lower extremity power and endurance

    Five Times Sit to Stand Test will be used to measure repetitive movement performance. The patient will be asked to sit down and stand up 5 times as quickly as possible, and this time will be recorded in seconds.

    Baseline and the end of the 8 weeks exercise program

  • Change in walking speed

    10-Meter Walk Test will be applied to assess walking speed. The first 2 meters of the 14-meter distance are allocated for acceleration, the last 2 meters for deceleration, and the time taken to walk the 10-meter distance is recorded. Walking speed is calculated in meters per second.

    Baseline and the end of the 8 weeks exercise program

  • Change in mobility

    Timed Up and Go Test is used to assess mobility, balance, and risk of falling. The patient is asked to stand up from a chair, walk around a cone 3 meters away, and return to sit on the chair. The total time is recorded using a stopwatch.

    Baseline and the end of the 8 weeks exercise program

  • Change in body position

    Activities-Specific Balance Confidence is a measure that assesses a person's level of confidence in their balance both indoors and outdoors. It consists of 16 different activities and is rated on a scale from no confidence (-0) to complete confidence (-100). A higher score indicates a greater level of confidence in balance.

    Baseline and the end of the 8 weeks exercise program

  • Change in quality of life

    The Parkinson's Disease Quality of Life Questionnaire (PDQ-39) will be used to assess quality of life. It consists of 39 items and is composed of 8 sub-parameters: mobility, activities of daily living, stigma, social support, communication, emotional well-being, and physical discomfort. As the score increases, quality of life deteriorates.

    Baseline and the end of the 8 weeks exercise program

Study Arms (2)

Self-Management Group

EXPERIMENTAL

The self-management group will perform the exercise programme prescribed by the physical therapist and tailored to the patient's needs via a web-based system twice a week for eight weeks, at a time of their choosing.

Other: Telerehabilitation

Telerehabilitation Group

ACTIVE COMPARATOR

Telerehabilitation group will perform the exercise programme prescribed by the physical therapist and tailored to the patient's needs via a web-based system twice a week for eight weeks.

Other: Telerehabilitation

Interventions

The exercises will consist of stretching, strengthening, balance, and neuromotor exercises that the patient can perform independently at home.

Self-Management GroupTelerehabilitation Group

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with Idiopathic Parkinson's Disease by a neurologist according to the UK Parkinson's Disease Association Brain Bank clinical diagnostic criteria
  • H\&Y Stage I-III
  • Montreal Cognitive Assessment Scale MoCA≥21
  • Having the necessary technological devices to participate in telerehabilitation
  • Being able to walk 100 meters
  • Having at least a primary school diploma

You may not qualify if:

  • Presence of a neurological disorder other than Parkinson's disease
  • Presence of any cardiopulmonary or musculoskeletal problem that affects gait and balance
  • Receiving Deep Brain Stimulation (DBS) treatment or having undergone DBS surgery in the past
  • Presence of vision or hearing problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Maltepe, Istanbul, 34852, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • Franchignoni F, Giordano A, Ronconi G, Rabini A, Ferriero G. Rasch validation of the Activities-specific Balance Confidence Scale and its short versions in patients with Parkinson's disease. J Rehabil Med. 2014 Jun;46(6):532-9. doi: 10.2340/16501977-1808.

    PMID: 24687205BACKGROUND
  • Huang SL, Hsieh CL, Wu RM, Tai CH, Lin CH, Lu WS. Minimal detectable change of the timed "up & go" test and the dynamic gait index in people with Parkinson disease. Phys Ther. 2011 Jan;91(1):114-21. doi: 10.2522/ptj.20090126. Epub 2010 Oct 14.

    PMID: 20947672BACKGROUND
  • Dean CM, Richards CL, Malouin F. Walking speed over 10 metres overestimates locomotor capacity after stroke. Clin Rehabil. 2001 Aug;15(4):415-21. doi: 10.1191/026921501678310216.

    PMID: 11518442BACKGROUND
  • Duncan RP, Leddy AL, Earhart GM. Five times sit-to-stand test performance in Parkinson's disease. Arch Phys Med Rehabil. 2011 Sep;92(9):1431-6. doi: 10.1016/j.apmr.2011.04.008.

    PMID: 21878213BACKGROUND
  • Goetz CG, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stebbins GT, Stern MB, Tilley BC, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, Van Hilten JJ, LaPelle N. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clinimetric testing plan. Mov Disord. 2007 Jan;22(1):41-7. doi: 10.1002/mds.21198.

    PMID: 17115387BACKGROUND
  • Fahn S. Unified Parkinson's disease rating scale. Recent developments in Parkinson's disease. 1987:153-63.

    BACKGROUND
  • Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.

    PMID: 33848468BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Semra Oğuz, PhD

    Marmara University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PT

Study Record Dates

First Submitted

December 11, 2025

First Posted

December 24, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

November 7, 2026

Study Completion (Estimated)

December 2, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations