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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
cervical spinal stabilization exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

working group

Arm Description

Outcomes

Primary Outcome Measures

Static Posturography
balance measurement (Number of Participants estimated 20 individuals)
X-Ray Measure
scoliosis graphy
Bubble Inclinometer
measurement of spine curvature angle (Number of Participants estimated 20 individuals)
Scoliometer
measurement of spine curvature angle
UPDRS
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.
Berg Balance Scale
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.
Posture Analyse
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
Cervical Proprioception
A tool used to evaluate the sense of proprioception in the cervical region of the participants with the Cervical Range of Measure(CROM) device
Visual Analog Scale
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.
10 meter walk test
walking speed calculation
Timed Get up and Walk Test
walking time and cadence calculation
Cervical Ventral Endurance Evaluation
Endurance evaluation will be done to deep cervical flexor extensor muscles
Muscle Strength Assessment
evaluation of the strength of the muscles in the cervical region and shoulder circumference
Evaluation of Muscle Shortness
measurement of shortness of some muscles in upper extremity and lower extremity with goniometer and tape measure
Normal Joint Movement Assessment
measurement of normal range of motion
Short Form-36
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.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2019
Last Updated
October 18, 2021
Sponsor
Hacettepe University
Collaborators
BElibol, NKöse, GYÇakmaklı, SAksoy, RGöçmen
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1. Study Identification

Unique Protocol Identification Number
NCT03854747
Brief Title
The Effect of Cervical Spinal Stabilization Exercises in Patients With Parkinson's Disease
Official Title
Investigation of the Effect of Cervical Spinal Stabilization Exercises on Spinal Posture, Cervical Proprioception and Postural Instability in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
July 26, 2019 (Actual)
Study Completion Date
August 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
BElibol, NKöse, GYÇakmaklı, SAksoy, RGöçmen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Title
working group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
cervical spinal stabilization exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Static Posturography
Description
balance measurement (Number of Participants estimated 20 individuals)
Time Frame
baseline to 8 week after
Title
X-Ray Measure
Description
scoliosis graphy
Time Frame
baseline to 8 week after
Title
Bubble Inclinometer
Description
measurement of spine curvature angle (Number of Participants estimated 20 individuals)
Time Frame
baseline to 8 week after
Title
Scoliometer
Description
measurement of spine curvature angle
Time Frame
baseline to 8 week after
Title
UPDRS
Description
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.
Time Frame
baseline to 8 week after
Title
Berg Balance Scale
Description
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.
Time Frame
baseline to 8 week after
Title
Posture Analyse
Description
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
Time Frame
baseline to 8 week after
Title
Cervical Proprioception
Description
A tool used to evaluate the sense of proprioception in the cervical region of the participants with the Cervical Range of Measure(CROM) device
Time Frame
baseline to 8 week after
Title
Visual Analog Scale
Description
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.
Time Frame
baseline to 8 week after
Title
10 meter walk test
Description
walking speed calculation
Time Frame
baseline to 8 week after
Title
Timed Get up and Walk Test
Description
walking time and cadence calculation
Time Frame
baseline to 8 week after
Title
Cervical Ventral Endurance Evaluation
Description
Endurance evaluation will be done to deep cervical flexor extensor muscles
Time Frame
baseline to 8 week after
Title
Muscle Strength Assessment
Description
evaluation of the strength of the muscles in the cervical region and shoulder circumference
Time Frame
baseline to 8 week after
Title
Evaluation of Muscle Shortness
Description
measurement of shortness of some muscles in upper extremity and lower extremity with goniometer and tape measure
Time Frame
baseline to 8 week after
Title
Normal Joint Movement Assessment
Description
measurement of normal range of motion
Time Frame
baseline to 8 week after
Title
Short Form-36
Description
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.
Time Frame
baseline to 8 week after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
22895940
Citation
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.
Results Reference
background
PubMed Identifier
18344392
Citation
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.
Results Reference
background
PubMed Identifier
19711119
Citation
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.
Results Reference
background
PubMed Identifier
25225533
Citation
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.
Results Reference
background
PubMed Identifier
16686575
Citation
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.
Results Reference
background
PubMed Identifier
22684202
Citation
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.
Results Reference
background

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

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