Effect of Sensorimotor Training on Upper Extremity in Parkinson's Patients

Parkinson Disease Clinical Trial

Official title:

Investigation of the Effect of Sensorimotor Training on Upper Extremity Functions, Activity and Participation in Parkinson's Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05241015
• Other study ID #: 2021/295 (Erciyes University)
• Status: Completed
• Phase: N/A
• Start date: December 8, 2021
• Est. completion date: November 20, 2023

Study information

• Verified date: February 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Control Group
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.
• Exercises Group
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.

Locations

Country	Name	City	State
Turkey	Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation	Kayseri

Sponsors (3)

Lead Sponsor	Collaborator
Hacettepe University	Nuh Naci Yazgan University, TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posture Analysis	New York Posture Rating Chart	Change from baseline at 8 week
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Touch threshold	Semmes Weinstein Monofilament Test will be used to evaluate upper extremity touch threshold.	Change from baseline at 8 week
Primary	Pain threshold	Algometer will be used to evaluate upper extremity pain threshold.	Change from baseline at 8 week
Primary	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
Primary	Hand Grip Strength	Hand Dynamometer will be used to measure hand grip strength.	Change from baseline at 8 week
Primary	Pinch Grip Strength	Pinch meter will be used to measure pinch grip strength.	Change from baseline at 8 week
Primary	Endurance of Cervical Muscles	Craniocervical Flexion (CSF) test, Evaluation of cervical flexor-extensor muscles	Change from baseline at 8 week
Primary	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
Primary	Hand functions	Purdue Pegboard Test (PPT)	Change from baseline at 8 week
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Motor speed	Motor speed will be evaluated using the Finger tapping test.	Change from baseline at 8 week