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Parkinson DiseaseNCT05703217

C Mill Virtual Reality Applied Rehabilitation and Classical Rehabilitation on Gait and Balance in Parkinson's Patients

A study testing classical physical therapy with physiotherapy. in people with Parkinson Disease and Rehabilitation, run by Romatem Bursa Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this research; the investigators would like to compare the results of patients with Parkinson's disease in the two groups who received classical physical therapy and rehabilitation program and virtual reality assisted walking and balance exercise at the beginning (1st rehabilitation day =1. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Parkinson Disease, Rehabilitation
What is being tested?
classical physical therapy with physiotherapy.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2022to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women and men
  • 60-80 years old Those who have been diagnosed with Parkinson's disease and are using regular drug therapy
  • Hoehn Yahr Stage: 2-3-4
  • Hoehn-Yahr Staging:
  • Stage 0- No signs of disease. Stage 1- Unilateral disease. Stage 1.5- Unilateral plus axial involvement. Stage 2- Bilateral disease, no balance disorder. Stage 2.5- Mild bilateral disease recovering in the pull test. Stage 3 - Mild to moderate bilateral disease and some postural instability, physically independent.
  • Stage 4 - Severe disability, able to stand and walk unaided. Stage 5 - unassisted wheelchair or bed dependent. Can be mobilized without support or with minimal support

Who cannot join

  • Criteria for exclusion of volunteers from the study:
  • psychiatric illness, dementia
  • advanced vision and hearing problems
  • diseases that limit walking and movement: joint disease (knee, hip joint diseases), advanced spinal stenosis, lumbar discopathy, hemiplegia
  • heart failure and respiratory failure

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Romatem Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospitals Bursa Hospital

    Bursa, 16030

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of C Mill Virtual Reality Applied Rehabilitation and Classical Rehabilitation on Gait and Balance in Parkinson's Patients: Randomized Controlled Study

In this research; the investigators would like to compare the results of patients with Parkinson's disease in the two groups who received classical physical therapy and rehabilitation program and virtual reality assisted walking and balance exercise at the beginning (1st rehabilitation day =1. day) and end of rehabilitation (21st rehabilitation day=50.day). In addition, the investigators aimed to reveal the change of gait and balance parameters by measuring the C-mill walking and balance rehabilitation device with numerical data and graphic analysis.

Read the detailed description

BASIS AND JUSTIFICATION OF THE RESEARCH: : In Parkinson's patients, difficulty in walking, slowing down in movements, difficulties in starting and maintaining walking become evident in Hoehn Yahr stage 2-3-4 stages of the disease. In addition to drug therapy, physical therapy and rehabilitation applications have proven to be effective in conditions such as walking and movement restriction in Parkinson's patients. Rehabilitation with a physiotherapist, controlled home exercise programs, and robot-assisted rehabilitation practices were all found to be effective in the clinic.

EXPECTED BENEFITS AFTER THE RESEARCH: It improves the patient's daily life activities and tests of all kinds of FTR applications. With the rehabilitation the investigators will implement, the investigators will help patients to be able to walk, sit and stand up unaided and independently. The investigators expect an increase in exercise capacity, an increase in walking distance, an improvement in balance and walking, and an increase in balance and walking measurements.

RESEARCH METHOD:

  1. All measurements 1st day when rehabilitation applications started and 50th day when rehabilitation applications end.
  2. To evaluate whether they benefit from the applied rehabilitation; Changes in the patient's own values will be compared on the first day and the last day of rehabilitation.
  3. It will be determined whether there is a difference between the scales and values between the two groups in which classical rehabilitation and C mill virtual reality applied rehabilitation.
  4. In order to determine the neurological examination status of the patients: UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor: maximum 56 points and a high score is considered bad. Regarding balance and walking: Tinetti test: the maximum possible score is 28, a high score is considered good. To measure the time it takes to get up and walk 3 meters from the seat, turn and sit in the chair that he/she started again: The time up and go test: normal value: It was determined as less than 12 seconds. To determine their own thoughts about the quality of life and the health of the patient: Short Form Health Survey-36: Norm values for the Turkish society have been determined, and the values received by the patients will be interpreted accordingly. To determine the ability to walk: Functional Ambulation Classification (FAC): A value between 0 and 5. A high score is determined as good.
  5. Walking parameters:Measurements will be made with a C mill walking and balance rehabilitation device.

It is known that walking speed, walking distance, walking time, step length, and number of steps per minute decrease in Parkinson's patients. In order to measure whether there is an increase or change in these values with rehabilitation: Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes: Single stance phase (%), Single stance time (s), weight transfer %, right and left stride length (cm), two stride length (cm), symmetry ( %), walking distance (m), walking time (minute), walking speed (km/h), total number of steps and number of steps per minute.

Being tested
classical physical therapy with physiotherapy.
Keywords
Parkinson Disease, Rehabilitation, Gait, Balance
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • classical physical therapy with physiotherapy.Procedure or surgery

    Also called C mill virtual reality applied rehabilitation

    C-Mill device: It is possible to stand and walk on the treadmill. The patient is fixed to the moving band by attaching a garment made of corset-like straps, and thanks to this system, the risk of falling of the patient is prevented. There are virtual reality applications on the treadmill floor and on the giant screen opposite: ball collection It provides adaptation of walking to normal life with animal figures, forest or street images, sounds. In classical physical therapy, muscle strengthening, sitting, standing and walking exercises will be performed with physiotherapy.

Study groups in NCT05703217
Study groupRoleWhat they receive
classical physical therapy and rehabilitation programActive comparatorIn classical physical therapy, muscle strengthening, sitting, standing and walking exercises will be performed with physiotherapy.
Receives: Procedure: classical physical therapy with physiotherapy.
virtual reality assisted walking and balance exercise programActive comparatorC-Mill device: It is possible to stand and walk on the treadmill. The patient is fixed to the moving band by attaching a garment made of corset-like straps, and thanks to this system, the risk of falling of the patient is prevented. There are virtual reality applications on the treadmill floor and on the giant screen opposite: ball collection It provides adaptation of walking to normal life with animal figures, forest or street images, sounds.
Receives: Procedure: classical physical therapy with physiotherapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor

    In order to determine the neurological examination status of the patients: UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor: maximum 56 points and a high score is considered bad

    Measured: 1st day: when rehabilitation applications started

  2. UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor

    In order to determine the neurological examination status of the patients: UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor: maximum 56 points and a high score is considered bad

    Measured: 50th day: when rehabilitation applications end

  3. Tinetti test

    Regarding balance and walking: Tinetti test: the maximum possible score is 28, a high score is considered good.

    Measured: 1st day: when rehabilitation applications started

  4. Tinetti test

    Regarding balance and walking: Tinetti test: the maximum possible score is 28, a high score is considered good.

    Measured: 50th day: when rehabilitation applications end

  5. The time up and go test

    To measure the time it takes to get up and walk 3 meters from the seat, turn and sit in the chair that he/she started again: The time up and go test: normal value: It was determined as less than 12 seconds.

    Measured: 1st day: when rehabilitation applications started

  6. The time up and go test

    To measure the time it takes to get up and walk 3 meters from the seat, turn and sit in the chair that he/she started again: The time up and go test: normal value: It was determined as less than 12 seconds.

    Measured: 50th day: when rehabilitation applications end

  7. Short Form Health Survey-36

    To determine their own thoughts about the quality of life and the health of the patient: Short Form Health Survey-36: Norm values for the Turkish society have been determined, and the values received by the patients will be interpreted accordingly.

    Measured: 1st day: when rehabilitation applications started

  8. Short Form Health Survey-36

    To determine their own thoughts about the quality of life and the health of the patient: Short Form Health Survey-36: Norm values for the Turkish society have been determined, and the values received by the patients will be interpreted accordingly.

    Measured: 50th day: when rehabilitation applications end

  9. Functional Ambulation Classification (FAC)

    To determine the ability to walk: Functional Ambulation Classification (FAC): A value between 0 and 5. A high score is determined as good.

    Measured: 1st day: when rehabilitation applications started

  10. Functional Ambulation Classification (FAC)

    To determine the ability to walk: Functional Ambulation Classification (FAC): A value between 0 and 5. A high score is determined as good.

    Measured: 50th day: when rehabilitation applications end

  11. Single stance phase (%)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 1st day: when rehabilitation applications started

  12. Single stance phase (%)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 50th day:when rehabilitation applications end

  13. single stance time (s)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 1st day: when rehabilitation applications started d

  14. single stance time (s)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 50th day: when rehabilitation applications end

  15. two stride length (cm)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 1st day: when rehabilitation applications started

  16. two stride length (cm)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 50th day :when rehabilitation applications end

  17. right stride length (cm)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 1st day: when rehabilitation applications started

  18. right stride length (cm),

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 50th day: when rehabilitation applications end

  19. left stride length (cm)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 1st day: when rehabilitation applications started

  20. left stride length (cm)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 50th day: when rehabilitation applications end

  21. walking distance (m)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 1st day: when rehabilitation applications started

  22. walking distance (m)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 50th day: when rehabilitation applications end

  23. walking time (minute)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 1st day: when rehabilitation applications started

  24. walking time (minute)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 50th day: when rehabilitation applications end

  25. walking speed (km/h)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 1st day: when rehabilitation applications started

  26. walking speed (km/h)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 50th day: when rehabilitation applications end

  27. step symmetry ( %)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 1st day: when rehabilitation applications started

  28. step symmetry ( %)

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 50th day: when rehabilitation applications end

  29. number of steps per minute.

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 1st day: when rehabilitation applications started

  30. number of steps per minute.

    Measurements will be made with a C mill walking and balance rehabilitation device. The following measurements will be made by walking at the speed at which the patient can walk comfortably, for a maximum of 5 minutes

    Measured: 50th day: when rehabilitation applications end

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start1 Jun 2022
  3. Primary completion1 May 2024
  4. Study completion1 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled study
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05703217
Sponsor's protocol ID
2022-4/1
Status last verified
Jan 2026
First submitted
31 Oct 2022
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all collected IPD, all IPD that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A study testing classical physical therapy with physiotherapy. in people with Parkinson Disease and Rehabilitation, run by Romatem Bursa Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

UPDR s-III: Unified Parkinson's Disease Rating Scale-Motor (time frame: 1st day: when rehabilitation applications started). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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