- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06147726
Upper Extremity Rehabilitation With Virtual Reality in Parkinson's Disease Patients
Effectiveness of Virtual Reality Supported Upper Extremity Position Matching Exercises in Parkinson's Disease Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
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Bolu, Merkez, Turkey (Türkiye), 14100
- Faculty of Health Sciences Bolu Abant Izzet Baysal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Accepting to participate in the research
- Being diagnosed with Parkinson's Disease by a neurologist
- Continuing anti-parkinsonian medication
- Hoehn-Yahr (H-Y) stage 3 and below
- Ability to walk independently
- To have full range of motion in shoulder abduction and elbow extension movements
Exclusion Criteria:
- Presence of additional neurological diseases other than Parkinson's Disease
- Scores below 21 on the Montreal Cognitive Assessment Scale
- Change in medication dosage in the last 1 month
- Severe visual impairment or complete hearing impairment in both ears
- Having a rheumatologic, musculoskeletal, etc. disease that may affect upper extremity functions
- The occurrence of severe tremors or dyskinesias due to the end of the drug dose
- Failing the Titmus butterfly test
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: VR group
group to receive virtual reality supported upper extremity rehabilitation in addition to conventional physiotherapy
|
In addition to conventional treatment approaches for 20 minutes 2 days a week for 8 weeks, joint positioning exercises (4 different game sequences of 4 minutes, 1 minute rest between each sequence, total 20 minutes) designed specifically for the individual's existing range of motion will be applied to the VR group.
proprioceptive neuromuscular facilitation techniques, parkinson-specific upper extremity and balance and gait exercises
|
|
Active Comparator: Control group
The group that will receive conventional physiotherapy for the total treatment time of the VR group
|
proprioceptive neuromuscular facilitation techniques, parkinson-specific upper extremity and balance and gait exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proprioception Assessment
Time Frame: through study completion, an average of 1 year
|
Position, i.e. proprioceptive sensation, will be evaluated with the "angle repetition test", one of the methods commonly used in the clinic.
The person will be positioned in a sitting position with his/her back unsupported and feet touching the floor.
The angle repetition test will be performed with a mobile device fixed above the elbow and between the shoulder.
The person's eyes will be closed during the assessment to prevent the learning effect and the use of visual reference.
After the shoulder is brought to the reference angle, the person is allowed to perceive the angle by waiting 10 seconds.
The person will then be asked to bring his/her shoulder to the side of his/her body and then repeat the taught reference angle as he/she perceived it.
The absolute value of the angle deviated from the target will be recorded.
Measurements in the shoulder joint will be made at 40° and 100° angles.
|
through study completion, an average of 1 year
|
|
Box and Block Test (BBT)
Time Frame: through study completion, an average of 1 year
|
The Box and Block Test (BBT) is widely used in neurological rehabilitation to assess upper extremity motor function, gross manual dexterity, and coordination. The test apparatus consists of a partitioned box measuring 53.7 × 25.4 × 8.5 cm and 150 wooden cubes. During administration, the box is placed in front of the participant with the partition aligned to the midline. The participant is instructed to transfer the cubes from one compartment to the other using the test hand as quickly as possible. At the end of the trial, the therapist records the score by counting the number of cubes successfully transferred. |
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unified Parkinson's Disease Rating Scale
Time Frame: through study completion, an average of 1 year
|
It is the most frequently used, valid and reliable scale for the assessment of impairments and disabilities in PD.
It contains 42 items, consists of 4 sections and assesses patients' mental status, behavior and mental state (4 items), activities of daily living (13 items), motor functions (14 items) and treatment complications (11 items), respectively.
Mental status; 16 points, activities of daily living; 52 points, motor functions; 108 points and treatment complications; 23 points, totaling 199 points.
Higher scores indicate worsening of the patient's condition.
An 8-point change in the total score was found to determine minimal clinically significant change.
|
through study completion, an average of 1 year
|
|
Disabilities of the Arm, Shoulder, and Hand Questionnaire
Time Frame: through study completion, an average of 1 year
|
It is a questionnaire consisting of a total of 30 questions used to evaluate the ability of the patient with upper extremity problems in activities of daily living and upper extremity functions.
The first 21 questions ask about the degree of difficulty in performing various activities of daily living with the dominant limb in the last week, the next 5 questions ask about the degree of pain, numbness, weakness during activities and the last 4 questions ask about the effect of pathologies on sleep, work, social life and psychological status.
For each question, the patient marked the appropriate response on a 5-point Likert-type scale. 1 indicates no difficulty, 2 indicates mild difficulty, 3 indicates moderate difficulty, 4 indicates extreme difficulty, and 5 indicates no difficulty at all.
The questionnaire is evaluated between 30 and 150 points.
|
through study completion, an average of 1 year
|
|
Parkinson's Disease Questionnaire (PDQ-8)
Time Frame: through study completion, an average of 1 year
|
The questions in the PDQ-8 assess the condition of the individual in the last 1 month and are scored between 0 (never) and 4 (always).
The total score is converted to a 100-point system and a high score indicates a decrease in quality of life.
|
through study completion, an average of 1 year
|
|
Intrinsic Motivation Inventory (IMI)
Time Frame: average 1 year after the completion of the study
|
The Intrinsic Motivation Inventory (IMI) is used to assess motivation and satisfaction during task performance.
It is a multidimensional questionnaire that evaluates interest/enjoyment, perceived competence, pressure/tension, perceived choice, and value/usefulness.
Responses are rated on a Likert scale ranging from "not at all true" to "very true."
The total motivation score is calculated by summing the item scores.
|
average 1 year after the completion of the study
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ramazan Kurul, Ph.D, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-BENLI-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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