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

Sponsor

Hacettepe University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05241015

Collaborator

TC Erciyes University (Other), Nuh Naci Yazgan University (Other)

Enrollment

Location

Arms

11.8

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: Control Group Other: Exercises Group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 8, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
Experimental: Exercises Group In addition to standard physiotherapy programme, patients in this group will also receive sensorimotor training.	Other: 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.

Arm

Intervention/Treatment

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.

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.

Experimental: Exercises Group

In addition to standard physiotherapy programme, patients in this group will also receive sensorimotor training.

Other: 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.

Outcome Measures

Primary Outcome Measures

Posture Analysis [Change from baseline at 8 week]
New York Posture Rating Chart
Tremor [Change from baseline at 8 week]
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 [Change from baseline at 8 week]
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 [Change from baseline at 8 week]
For proprioception, joint position error in the cervical region and upper extremity will be evaluated with the laser kit.
Tactile acuity [Change from baseline at 8 week]
For upper extremity tactile acuity, moving 2-point discrimination test (MTPD) will be performed using an esthesiometer.
Touch threshold [Change from baseline at 8 week]
Semmes Weinstein Monofilament Test will be used to evaluate upper extremity touch threshold.
Pain threshold [Change from baseline at 8 week]
Algometer will be used to evaluate upper extremity pain threshold.
Pain intensity [Change from baseline at 8 week]
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 [Change from baseline at 8 week]
Hand Dynamometer will be used to measure hand grip strength.
Pinch Grip Strength [Change from baseline at 8 week]
Pinch meter will be used to measure pinch grip strength.
Endurance of Cervical Muscles [Change from baseline at 8 week]
Craniocervical Flexion (CSF) test, Evaluation of deep cervical extensor muscles
Fatigue [Change from baseline at 8 week]
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 [Change from baseline at 8 week]
Purdue Pegboard Test (PPT)
Dual Task Performance [Change from baseline at 8 week]
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 [Change from baseline at 8 week]
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 [Change from baseline at 8 week]
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 [Change from baseline at 8 week]
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 [Change from baseline at 8 week]
Motor speed will be evaluated using the Finger tapping test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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