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Completed

NCT Number: NCT03854747

The Effect of Cervical Spinal Stabilization Exercises 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cervical spinal stabilization exercise

Other

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 outcomes

  1. Static Posturography

    Time frame: baseline to 8 week after

    balance measurement (Number of Participants estimated 20 individuals)

  2. X-Ray Measure

    Time frame: baseline to 8 week after

    scoliosis graphy

  3. Bubble Inclinometer

    Time frame: baseline to 8 week after

    measurement of spine curvature angle (Number of Participants estimated 20 individuals)

  4. Scoliometer

    Time frame: baseline to 8 week after

    measurement of spine curvature angle

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 10 meter walk test

    Time frame: baseline to 8 week after

    walking speed calculation

  11. Timed Get up and Walk Test

    Time frame: baseline to 8 week after

    walking time and cadence calculation

  12. Cervical Ventral Endurance Evaluation

    Time frame: baseline to 8 week after

    Endurance evaluation will be done to deep cervical flexor extensor muscles

  13. Muscle Strength Assessment

    Time frame: baseline to 8 week after

    evaluation of the strength of the muscles in the cervical region and shoulder circumference

  14. 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

  15. Normal Joint Movement Assessment

    Time frame: baseline to 8 week after

    measurement of normal range of motion

  16. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • BElibol
  • GYÇakmaklı
  • NKöse
  • RGöçmen
  • SAksoy

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2019
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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