Effect of Sensorimotor Training on Upper Extremity in Parkinson's Patients
Primary Purpose
Parkinson Disease
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Control Group
Exercises Group
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson, Upper Extremity, Sensorimotor Training, ICF, Function
Eligibility Criteria
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
Sites / Locations
- Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Exercises Group
Arm Description
Patients in this group will receive standard physiotherapy program used for PD will be applied, 3 times a week for 8 weeks.
In addition to standard physiotherapy programme, patients in this group will also receive sensorimotor training.
Outcomes
Primary Outcome Measures
Posture Analysis
New York Posture Rating Chart
Tremor
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.
Unified Parkinson's Disease Rating Scale
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.
Proprioception
For proprioception, joint position error in the cervical region and upper extremity will be evaluated with the laser kit.
Tactile acuity
For upper extremity tactile acuity, moving 2-point discrimination test (MTPD) will be performed using an esthesiometer.
Touch threshold
Semmes Weinstein Monofilament Test will be used to evaluate upper extremity touch threshold.
Pain threshold
Algometer will be used to evaluate upper extremity pain threshold.
Pain intensity
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.
Hand Grip Strength
Hand Dynamometer will be used to measure hand grip strength.
Pinch Grip Strength
Pinch meter will be used to measure pinch grip strength.
Endurance of Cervical Muscles
Craniocervical Flexion (CSF) test, Evaluation of deep cervical extensor muscles
Fatigue
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.
Hand functions
Purdue Pegboard Test (PPT)
Dual Task Performance
During the Purdue Pegboard Test, the second task will be added and the completion time will be recorded.
Disabilities of the Arm, Shoulder and Hand Questionnaire
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.
Quality of life evaluation
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.
Evaluation of Environmental Factors
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.
Motor speed
Motor speed will be evaluated using the Finger tapping test.
Secondary Outcome Measures
Full Information
NCT ID
NCT05241015
First Posted
January 7, 2022
Last Updated
March 6, 2023
Sponsor
Hacettepe University
Collaborators
TC Erciyes University, Nuh Naci Yazgan University
1. Study Identification
Unique Protocol Identification Number
NCT05241015
Brief Title
Effect of Sensorimotor Training on Upper Extremity in Parkinson's Patients
Official Title
Investigation of the Effect of Sensorimotor Training on Upper Extremity Functions, Activity and Participation in Parkinson's Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
TC Erciyes University, Nuh Naci Yazgan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson, Upper Extremity, Sensorimotor Training, ICF, Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive standard physiotherapy program used for PD will be applied, 3 times a week for 8 weeks.
Arm Title
Exercises Group
Arm Type
Experimental
Arm Description
In addition to standard physiotherapy programme, patients in this group will also receive sensorimotor training.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercises Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Posture Analysis
Description
New York Posture Rating Chart
Time Frame
Change from baseline at 8 week
Title
Tremor
Description
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.
Time Frame
Change from baseline at 8 week
Title
Unified Parkinson's Disease Rating Scale
Description
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.
Time Frame
Change from baseline at 8 week
Title
Proprioception
Description
For proprioception, joint position error in the cervical region and upper extremity will be evaluated with the laser kit.
Time Frame
Change from baseline at 8 week
Title
Tactile acuity
Description
For upper extremity tactile acuity, moving 2-point discrimination test (MTPD) will be performed using an esthesiometer.
Time Frame
Change from baseline at 8 week
Title
Touch threshold
Description
Semmes Weinstein Monofilament Test will be used to evaluate upper extremity touch threshold.
Time Frame
Change from baseline at 8 week
Title
Pain threshold
Description
Algometer will be used to evaluate upper extremity pain threshold.
Time Frame
Change from baseline at 8 week
Title
Pain intensity
Description
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.
Time Frame
Change from baseline at 8 week
Title
Hand Grip Strength
Description
Hand Dynamometer will be used to measure hand grip strength.
Time Frame
Change from baseline at 8 week
Title
Pinch Grip Strength
Description
Pinch meter will be used to measure pinch grip strength.
Time Frame
Change from baseline at 8 week
Title
Endurance of Cervical Muscles
Description
Craniocervical Flexion (CSF) test, Evaluation of deep cervical extensor muscles
Time Frame
Change from baseline at 8 week
Title
Fatigue
Description
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.
Time Frame
Change from baseline at 8 week
Title
Hand functions
Description
Purdue Pegboard Test (PPT)
Time Frame
Change from baseline at 8 week
Title
Dual Task Performance
Description
During the Purdue Pegboard Test, the second task will be added and the completion time will be recorded.
Time Frame
Change from baseline at 8 week
Title
Disabilities of the Arm, Shoulder and Hand Questionnaire
Description
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.
Time Frame
Change from baseline at 8 week
Title
Quality of life evaluation
Description
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.
Time Frame
Change from baseline at 8 week
Title
Evaluation of Environmental Factors
Description
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.
Time Frame
Change from baseline at 8 week
Title
Motor speed
Description
Motor speed will be evaluated using the Finger tapping test.
Time Frame
Change from baseline at 8 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation
City
Kayseri
Country
Turkey
12. IPD Sharing Statement
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Effect of Sensorimotor Training on Upper Extremity in Parkinson's Patients
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