- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05241015
Effect of Sensorimotor Training on Upper Extremity in Parkinson's Patients
Investigation of the Effect of Sensorimotor Training on Upper Extremity Functions, Activity and Participation in Parkinson's Patients
There are many factors affecting the upper extremity such as tremor, bradykinesia, rigidity, and postural instability in Parkinson's patients. According to the International Classification of Functioning, Disability and Health (ICF) model, there are restrictions on people's activities and participation in life due to structural and functional disorders affecting the upper extremity in PD.
In PD, integrating and using proprioceptive feedback, sensorimotor integration and peripheral sensory functions are reported to be impaired. Numerous studies show that the main source of motor problems in PD is dysfunction of sensorimotor integration. Since the cervical region contains a dense concentration of proprioceptive organs such as muscle spindles, it plays an important role in providing afferent proprioceptive information for postural control. Therefore, sensorimotor training targeting the cervical region gains importance. In this study, we aim to reduce PD-specific upper extremity disorders and related activity and participation limitations by increasing motor control in the cervical region with sensorimotor training. Patients with Parkinson's disease will be included in the study and randomly divided into 2 groups. While the general physiotherapy program will be applied to the control group, sensorimotor training will be given in addition to the exercise group.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kayseri, Turkey
- Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having idiopathic Parkinson's disease over the age of 40
- Meets the diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank
- Hoehn-Yahr Staging <3
- Mini mental test score of 24 and above
- In the "on" period
- Receiving oral therapy only
Exclusion Criteria:
- Patients receiving device-assisted therapy
- Patients receiving apomorphine therapy
- Patients with mini mental test scores below 24
- Patients who use drugs (antidepressants, etc.) that will affect cognitive functions
- Patients with hearing and speech problems
- Patients with orthopedic, neurological and vestibular problems other than Parkinson's that may prevent them from completing the tests and treatment
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 |
|---|---|
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Active Comparator: Control Group
Patients in this group will receive standard physiotherapy program used for PD will be applied, 3 times a week for 8 weeks.
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Treatment protocol; It will be applied to improve posture, strengthen muscles, eliminate shortness, increase flexibility, balance/coordination, sit up/stand up and in-bed mobilization, and improve gait.
Before taking the treatment, a general evaluation will be made and as a result of this evaluation, muscle shortness, loss of strength, postural disorders and the activities and positions they have the most difficulty in daily life will be determined.
Treatment programs will be shaped according to the problems determined in line with the evaluations made.
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Experimental: Exercises Group
In addition to standard physiotherapy programme, patients in this group will also receive sensorimotor training.
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In addition to the standard physiotherapy program, sensorimotor training including the cervical region will be given to the this group.
Deep cervical flexor and extensor muscles, which provide stability in the cervical region, will be trained.
A Pressure Biofeedback Device will be used to train the deep cervical flexors.
Both positional and kinesthetic sensory training will be provided by maintaining the stability of the cervical region by means of the laser kit that provides visual feedback.Additionally, oculomotor exercises will be given.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Posture Analysis
Time Frame: Change from baseline at 8 week
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New York Posture Rating Chart
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Change from baseline at 8 week
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Tremor
Time Frame: Change from baseline at 8 week
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Fahn; Tolosa, Marin Clinical Tremor Rating Scale will be used to evaluate tremor.
Each item was scored between 0-4.
A lower score is an indicator of better status.
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Change from baseline at 8 week
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Unified Parkinson's Disease Rating Scale
Time Frame: Change from baseline at 8 week
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Unified Parkinson's Disease Rating Scale is a scale that evaluates disability and disorders related to Parkinson's and consists of 4 main subtitles and 42 questions in total .
Each item was scored between 0-4 .
A lower score is an indicator of better status.
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Change from baseline at 8 week
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Proprioception
Time Frame: Change from baseline at 8 week
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For proprioception, joint position error in the cervical region and upper extremity will be evaluated with the laser kit.
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Change from baseline at 8 week
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Tactile acuity
Time Frame: Change from baseline at 8 week
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For upper extremity tactile acuity, moving 2-point discrimination test (MTPD) will be performed using an esthesiometer.
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Change from baseline at 8 week
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Touch threshold
Time Frame: Change from baseline at 8 week
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Semmes Weinstein Monofilament Test will be used to evaluate upper extremity touch threshold.
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Change from baseline at 8 week
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Pain threshold
Time Frame: Change from baseline at 8 week
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Algometer will be used to evaluate upper extremity pain threshold.
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Change from baseline at 8 week
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Pain intensity
Time Frame: Change from baseline at 8 week
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Visual pain scale (VAS) will be used to evaluate upper extremity pain.In the evaluation, pain averages ranging from 0 to 10 cm are given.
"0" indicates that there is no pain, while as the score increases, the severity of pain increases.
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Change from baseline at 8 week
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Hand Grip Strength
Time Frame: Change from baseline at 8 week
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Hand Dynamometer will be used to measure hand grip strength.
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Change from baseline at 8 week
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Pinch Grip Strength
Time Frame: Change from baseline at 8 week
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Pinch meter will be used to measure pinch grip strength.
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Change from baseline at 8 week
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Fatigue
Time Frame: Change from baseline at 8 week
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Parkinson's Fatigue Scale will be used to evaluate fatigue.
It is consists of 16 items related to presence of fatigue.
All items are scored by patients using a five-point Likert-type scale including response options ranging from '(1) strongly disagree' to '(5) strongly agree'.
A higher score indicates a higher level of fatigue.
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Change from baseline at 8 week
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Hand functions
Time Frame: Change from baseline at 8 week
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Purdue Pegboard Test (PPT)
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Change from baseline at 8 week
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Dual Task Performance
Time Frame: Change from baseline at 8 week
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During the Purdue Pegboard Test, the second task will be added and the completion time will be recorded.
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Change from baseline at 8 week
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Disabilities of the Arm, Shoulder and Hand Questionnaire
Time Frame: Change from baseline at 8 week
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It will be used to determine the problems experienced in the use of the upper extremity.
It consists of 3 sections.
All questions are answered according to a 5-point Likert system.
A score between 0-100 is obtained from each section.
The higher the score, the higher the disability.
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Change from baseline at 8 week
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Quality of life evaluation
Time Frame: Change from baseline at 8 week
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Parkinson's Disease Questionnaire (PDQ-39) will be used to evaluate quality of life.
It contains 39 items in total.
A score between 0 and 4 is given for each question.
A high overall score indicates worsening quality of life.
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Change from baseline at 8 week
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Evaluation of Environmental Factors
Time Frame: Change from baseline at 8 week
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Questions structured by the researchers will be used on the issues of support and attitudes under the environmental factors heading of the ICF model.
Questions are scored between 0 and 10.
A high score indicates high satisfaction.
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Change from baseline at 8 week
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Motor speed
Time Frame: Change from baseline at 8 week
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Motor speed will be evaluated using the Finger tapping test.
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Change from baseline at 8 week
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Endurance of Cervical Muscles
Time Frame: Change from baseline at 8 week
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Craniocervical Flexion (CSF) test, Evaluation of cervical flexor-extensor muscles
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Change from baseline at 8 week
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Collaborators and Investigators
Sponsor
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/295 (Erciyes University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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