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

NCT05703217 | Completed

• 1 other identifier: 2022-4/1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease; Rehabilitation

Keywords

Parkinson Disease; Rehabilitation; Gait; Balance

Outcome Measures

Primary Outcomes (30)

• 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

  1st day: when rehabilitation applications started

• 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

  50th day: when rehabilitation applications end

• Tinetti test

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

  1st day: when rehabilitation applications started

• Tinetti test

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

  50th day: when rehabilitation applications end

• 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.

  1st day: when rehabilitation applications started

• 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.

  50th day: when rehabilitation applications end

• 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.

  1st day: when rehabilitation applications started

• 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.

  50th day: when rehabilitation applications end

• 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.

  1st day: when rehabilitation applications started

• 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.

  50th day: when rehabilitation applications end

• 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

  1st day: when rehabilitation applications started

• 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

  50th day:when rehabilitation applications end

• 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

  1st day: when rehabilitation applications started d

• 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

  50th day: when rehabilitation applications end

• 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

  1st day: when rehabilitation applications started

• 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

  50th day :when rehabilitation applications end

• 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

  1st day: when rehabilitation applications started

• 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

  50th day: when rehabilitation applications end

• 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

  1st day: when rehabilitation applications started

• 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

  50th day: when rehabilitation applications end

• 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

  1st day: when rehabilitation applications started

• 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

  50th day: when rehabilitation applications end

• 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

  1st day: when rehabilitation applications started

• 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

  50th day: when rehabilitation applications end

• 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

  1st day: when rehabilitation applications started

• 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

  50th day: when rehabilitation applications end

• 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

  1st day: when rehabilitation applications started

• 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

  50th day: when rehabilitation applications end

• 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

  1st day: when rehabilitation applications started

• 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

  50th day: when rehabilitation applications end

Study Arms (2)

classical physical therapy and rehabilitation program

ACTIVE COMPARATOR

In classical physical therapy, muscle strengthening, sitting, standing and walking exercises will be performed with physiotherapy.

Procedure: classical physical therapy with physiotherapy.

virtual reality assisted walking and balance exercise program

ACTIVE COMPARATOR

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.

Procedure: classical physical therapy with physiotherapy.

Interventions

classical physical therapy with physiotherapy. PROCEDURE

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.

Also known as: C mill virtual reality applied rehabilitation

classical physical therapy and rehabilitation program; virtual reality assisted walking and balance exercise program

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Romatem Bursa Hospital: lead
• Bursa City Hospital: collaborator

Study Sites (1)

Romatem Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospitals Bursa Hospital

Bursa, 16030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• NERMİN ÇALIŞIR

  ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL

  STUDY DIRECTOR

• NURTEN KÜÇÜKÇAKIR

  ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL

  PRINCIPAL INVESTIGATOR

• SİNEM AKSELİM

  BURSA CİTY HOSPİTAL PHYSICAL THERAPY AND REHABILITATION HOSPITAL

  PRINCIPAL INVESTIGATOR

• Muhammed Ali DEMİRBAĞ

  ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL

  PRINCIPAL INVESTIGATOR

• RAFET AKAR

  ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL

  PRINCIPAL INVESTIGATOR

• ŞEYDA ÖNCÜL

  ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL

  PRINCIPAL INVESTIGATOR

• GÖKHAN KAYA

  ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL

  PRINCIPAL INVESTIGATOR

• ANIL YILMAZ

  ROMATEM ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALS BURSA HOSPITAL

  PRINCIPAL INVESTIGATOR

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: Principal İnvestigator,Head of Neurology

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: January 27, 2023
• Study Start: June 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: as a date relative to the time when summary data are published or otherwise made available (starting 7 months after publication).
• Access Criteria: all the data

Locations

TU (1)