- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03854747
The Effect of Cervical Spinal Stabilization Exercises in Patients With Parkinson's Disease
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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No Intervention: control group
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Experimental: working group
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static Posturography
Time Frame: baseline to 8 week after
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balance measurement (Number of Participants estimated 20 individuals)
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baseline to 8 week after
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X-Ray Measure
Time Frame: baseline to 8 week after
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scoliosis graphy
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baseline to 8 week after
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Bubble Inclinometer
Time Frame: baseline to 8 week after
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measurement of spine curvature angle (Number of Participants estimated 20 individuals)
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baseline to 8 week after
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Scoliometer
Time Frame: baseline to 8 week after
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measurement of spine curvature angle
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baseline to 8 week after
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UPDRS
Time Frame: baseline to 8 week after
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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.
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baseline to 8 week after
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Berg Balance Scale
Time Frame: baseline to 8 week after
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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.
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baseline to 8 week after
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Posture Analyse
Time Frame: baseline to 8 week after
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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
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baseline to 8 week after
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Cervical Proprioception
Time Frame: baseline to 8 week after
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A tool used to evaluate the sense of proprioception in the cervical region of the participants with the Cervical Range of Measure(CROM) device
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baseline to 8 week after
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Visual Analog Scale
Time Frame: baseline to 8 week after
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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.
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baseline to 8 week after
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10 meter walk test
Time Frame: baseline to 8 week after
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walking speed calculation
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baseline to 8 week after
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Timed Get up and Walk Test
Time Frame: baseline to 8 week after
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walking time and cadence calculation
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baseline to 8 week after
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Cervical Ventral Endurance Evaluation
Time Frame: baseline to 8 week after
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Endurance evaluation will be done to deep cervical flexor extensor muscles
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baseline to 8 week after
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Muscle Strength Assessment
Time Frame: baseline to 8 week after
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evaluation of the strength of the muscles in the cervical region and shoulder circumference
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baseline to 8 week after
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Evaluation of Muscle Shortness
Time Frame: baseline to 8 week after
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measurement of shortness of some muscles in upper extremity and lower extremity with goniometer and tape measure
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baseline to 8 week after
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Normal Joint Movement Assessment
Time Frame: baseline to 8 week after
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measurement of normal range of motion
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baseline to 8 week after
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Short Form-36
Time Frame: baseline to 8 week after
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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.
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baseline to 8 week after
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
- Kay TM, Gross A, Goldsmith CH, Rutherford S, Voth S, Hoving JL, Bronfort G, Santaguida PL. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD004250. doi: 10.1002/14651858.CD004250.pub4.
- Park A, Stacy M. Non-motor symptoms in Parkinson's disease. J Neurol. 2009 Aug;256 Suppl 3:293-8. doi: 10.1007/s00415-009-5240-1.
- Shujaat F, Soomro N, Khan M. The effectiveness of Kayaking exercises as compared to general mobility exercises in reducing axial rigidity and improve bed mobility in early to mid stage of Parkinson's disease. Pak J Med Sci. 2014 Sep;30(5):1094-8. doi: 10.12669/pjms.305.5231.
- Carter JM, Beam WC, McMahan SG, Barr ML, Brown LE. The effects of stability ball training on spinal stability in sedentary individuals. J Strength Cond Res. 2006 May;20(2):429-35. doi: 10.1519/R-18125.1.
- Kaya DO, Ergun N, Hayran M. Effects of different segmental spinal stabilization exercise protocols on postural stability in asymptomatic subjects: randomized controlled trial. J Back Musculoskelet Rehabil. 2012;25(2):109-16. doi: 10.3233/BMR-2012-0318.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Parkinson's disease treatment
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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