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
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 8, 2021
CompletedFirst Submitted
Initial submission to the registry
January 7, 2022
CompletedFirst Posted
Study publicly available on registry
February 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2023
CompletedFebruary 22, 2024
February 1, 2024
2 years
January 7, 2022
February 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (18)
Posture Analysis
New York Posture Rating Chart
Change from baseline at 8 week
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.
Change from baseline at 8 week
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.
Change from baseline at 8 week
Proprioception
For proprioception, joint position error in the cervical region and upper extremity will be evaluated with the laser kit.
Change from baseline at 8 week
Tactile acuity
For upper extremity tactile acuity, moving 2-point discrimination test (MTPD) will be performed using an esthesiometer.
Change from baseline at 8 week
Touch threshold
Semmes Weinstein Monofilament Test will be used to evaluate upper extremity touch threshold.
Change from baseline at 8 week
Pain threshold
Algometer will be used to evaluate upper extremity pain threshold.
Change from baseline at 8 week
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.
Change from baseline at 8 week
Hand Grip Strength
Hand Dynamometer will be used to measure hand grip strength.
Change from baseline at 8 week
Pinch Grip Strength
Pinch meter will be used to measure pinch grip strength.
Change from baseline at 8 week
Endurance of Cervical Muscles
Craniocervical Flexion (CSF) test, Evaluation of cervical flexor-extensor muscles
Change from baseline at 8 week
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.
Change from baseline at 8 week
Hand functions
Purdue Pegboard Test (PPT)
Change from baseline at 8 week
Dual Task Performance
During the Purdue Pegboard Test, the second task will be added and the completion time will be recorded.
Change from baseline at 8 week
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.
Change from baseline at 8 week
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.
Change from baseline at 8 week
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.
Change from baseline at 8 week
Motor speed
Motor speed will be evaluated using the Finger tapping test.
Change from baseline at 8 week
Study Arms (2)
Control Group
ACTIVE COMPARATORPatients in this group will receive standard physiotherapy program used for PD will be applied, 3 times a week for 8 weeks.
Exercises Group
EXPERIMENTALIn addition to standard physiotherapy programme, patients in this group will also receive sensorimotor training.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hacettepe Universitylead
- TC Erciyes Universitycollaborator
- Nuh Naci Yazgan Universitycollaborator
Study Sites (1)
Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation
Kayseri, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 7, 2022
First Posted
February 15, 2022
Study Start
December 8, 2021
Primary Completion
November 20, 2023
Study Completion
November 20, 2023
Last Updated
February 22, 2024
Record last verified: 2024-02