The Effect of Cervical Spinal Stabilization Exercises in Patients With Parkinson's Disease

October 18, 2021 updated by: Emine Nur Demircan, Hacettepe University

Investigation of the Effect of Cervical Spinal Stabilization Exercises on Spinal Posture, Cervical Proprioception and Postural Instability in Patients With Parkinson's Disease

Parkinson's disease (PH); it occurs due to dopamine deficiency due to the loss of dopaminergic neurons in a degenerative process in the substantia nigra found in the middle brain; resting tremor, bradykinesia, trunk and extremities rigidity, mask facial and postural instability characterized by a neurodegenerative disease. These findings are basic and also motor symptoms of Parkinson's Disease. Non-motor symptoms include many problems ranging from autonomic dysfunction to sensory symptoms.

Treatment of Parkinson's disease requires a multidisciplinary approach such as medical treatment, physiotherapy and rehabilitation, surgical treatment.

Physiotherapy programs applied to patients with Parkinson's disease include classical physiotherapy methods and neurophysiological based methods.

Spinal stabilization is an important concept for proper control of body balance and extremity movements. Spinal stabilization training was based on biomechanics, neurophysiology and physiotherapy research. Stabilization exercises, which form the basis of spinal stabilization training, increase the strength and endurance of the postural and stabilizing muscles using the basic principles of motor learning and improve stability control in stable and unstable positions, provides postural smoothness.

The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors.

Although studies have been carried out to investigate the effect of spinal stabilization exercises in Parkinson's patients, there is no study on the effect of cervical region stabilization exercises in the literature despite these important connections of the cervical region.

For these reasons, this study is planned to investigate the effects of cervical spinal stabilization exercises on spinal posture, cervical proprioception and postural instability in Parkinson's patients.

Hypothesis 1: When cervical spinal stabilization exercises are added to the traditional physiotherapy program in Parkinson's patients, it will be more effective in correcting spinal posture.

Hypothesis 2: When cervical spinal stabilization exercises are added to the traditional physiotherapy program in Parkinson's patients, cervical proprioception will develop better.

Hypothesis 3: In the case of Parkinson's patients, when the cervical spinal stabilization exercises are added to the traditional physiotherapy program, postural stability may be more pronounced.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson's disease,
  • Having planned a traditional physiotherapy program for Parkinson's disease and referring to Hacettepe University Faculty of Health Sciences Physiotherapy and Rehabilitation Department,
  • 40 to 80 years old,
  • According to Hoehn-Yahr scale to be in stage 2 or 3,
  • Having scored 30 points above the posture evaluation
  • Postural disorder in the femoral region, but the absence of structural disorder (congenital spinal deformities in medical evaluations prior to the study, structural disorders caused by other diseases should be determined that the spine does not have problems),
  • 26 points higher than the mini-mental test,
  • Disease duration is 3 years and above,
  • The absence of any other neurological disease other than vestibular and / or Parkinson's, which may affect muscle strength, balance and coordination,
  • Spinal colon and lower extremity musculoskeletal system, which may affect the stabilization of any surgery has been identified as.

Exclusion Criteria:

  • Volunteers who do not comply with the inclusion criteria will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
No Intervention: control group
Experimental: working group
The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors. Studies have shown that many position sense proprioceptors are over the deep group cervical muscles such as longus colitis and longus capitis. The deep group cervical muscles, which perform a dynamic ligament function, have an important role in maintaining the stability of the spine as well as the proprioceptive sense. In particular, proprioceptive receptors, which are commonly found in the deep suboccipital muscles; There are cervical and reflex connections with vestibular, visual and postural control systems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static Posturography
Time Frame: baseline to 8 week after
balance measurement (Number of Participants estimated 20 individuals)
baseline to 8 week after
X-Ray Measure
Time Frame: baseline to 8 week after
scoliosis graphy
baseline to 8 week after
Bubble Inclinometer
Time Frame: baseline to 8 week after
measurement of spine curvature angle (Number of Participants estimated 20 individuals)
baseline to 8 week after
Scoliometer
Time Frame: baseline to 8 week after
measurement of spine curvature angle
baseline to 8 week after
UPDRS
Time Frame: baseline to 8 week after
Unified Parkinson's Disease Rating Scale. There are 4 sub-parameters. 1. mental status, behavior and mental state 2. daily life activities 3. motor inspection 4. treatment complications. mental status, behavior and mental state total 16 points, daily activity total 52 points, Motor parameter total 92 points, treatment complications total 23 points. Total maximum 183 points. the total score is calculated by adding all sub-parameter scores. low value is good, high value is a symptom of bad result.
baseline to 8 week after
Berg Balance Scale
Time Frame: baseline to 8 week after
balance measurement. It is a 14-item balance scale. The range of points is between 0 and 56. The total score is calculated by summing the points of each item. high score good balance, low score indicates bad balance.
baseline to 8 week after
Posture Analyse
Time Frame: baseline to 8 week after
is a scale that evaluates the participant's 13 different regions from posterior and lateral to postural disorder. the scoring of each region is 1-3-5. if normal is 5 points, moderate level is 3 points, if there is any advanced disorder 1 point is given. the total score is determined by summing all the values. total maximum 65, minimum 13 points. high score good posture, low score indicates bad posture
baseline to 8 week after
Cervical Proprioception
Time Frame: baseline to 8 week after
A tool used to evaluate the sense of proprioception in the cervical region of the participants with the Cervical Range of Measure(CROM) device
baseline to 8 week after
Visual Analog Scale
Time Frame: baseline to 8 week after
Visual Analog Scala. Numerical rating scale of pain intensity. 0 to 10 is a scale with a rating. 0 points no pain 10 points is a scale with very severe pain. the participant is asked to say a value in this range according to the severity of pain.
baseline to 8 week after
10 meter walk test
Time Frame: baseline to 8 week after
walking speed calculation
baseline to 8 week after
Timed Get up and Walk Test
Time Frame: baseline to 8 week after
walking time and cadence calculation
baseline to 8 week after
Cervical Ventral Endurance Evaluation
Time Frame: baseline to 8 week after
Endurance evaluation will be done to deep cervical flexor extensor muscles
baseline to 8 week after
Muscle Strength Assessment
Time Frame: baseline to 8 week after
evaluation of the strength of the muscles in the cervical region and shoulder circumference
baseline to 8 week after
Evaluation of Muscle Shortness
Time Frame: baseline to 8 week after
measurement of shortness of some muscles in upper extremity and lower extremity with goniometer and tape measure
baseline to 8 week after
Normal Joint Movement Assessment
Time Frame: baseline to 8 week after
measurement of normal range of motion
baseline to 8 week after
Short Form-36
Time Frame: baseline to 8 week after
SF-36 (Short Form 36). Quality of life survey. examines 8 dimensions of health with 36 items. physical function, social function, role restrictions, mental health, vitality, pain and general health. The scores of each parameter are between 0 and 100. 0 bad, 100 good results. is calculated by taking the values of the sub-parameters.
baseline to 8 week after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2019

Primary Completion (Actual)

July 26, 2019

Study Completion (Actual)

August 2, 2019

Study Registration Dates

First Submitted

February 16, 2019

First Submitted That Met QC Criteria

February 23, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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