Clinical trial NCT04524143: The Acute Effect of Cervical Mobilization in Parkinson's Disease
Official title: The Acute Effect of Cervical Mobilization on Balance and Gait in Patients With Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's disease
Cervical Spine
Postural Balance
Gait
Manual Therapies
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 33
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled
Primary purpose: TREATMENT

Brief summary: Patients with Idiopathic Parkinson's disease have balance and gait problems due to sensory and motor impairments. In the literature, there are lots of studies including various approaches for rehabilitation of these parameters such as sensory interventions, conservative treatments, neurophysiological approaches and motor imagery. However, taking into account of literature, there is no study investigating the effects on balance and gait of cervical mobilization by stimulating proprioceptors and vestibular receptors. Therefore, the aim of this study is to investigate the acute effect of cervical mobilization on balance and gait in patients with idiopathic Parkinson's disease.

Detailed description: Patients with Idiopathic Parkinson's disease have balance and gait problems due to sensory and motor impairments. In the literature, there are lots of studies including various approaches for rehabilitation of these parameters such as sensory interventions, conservative treatments, neurophysiological approaches and motor imagery. The posture of the cervical region is impaired by the findings of the disease such as rigidity, flexor posture and loss of axial rotation. Considering that the cervical region is rich in proprioceptors and one of the key points for the vestibular system, interventions to this area can be thought to contribute to postural control and gait. However, taking into account of literature, there is no study investigating the effects on balance and gait of cervical mobilization by stimulating proprioceptors and vestibular receptors. Therefore, the aim of this study is to investigate the acute effect of cervical mobilization on balance and gait in patients with idiopathic Parkinson's disease.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with Idiopathic Parkinson's disease
* Being between the ages of 50-80
* Patients scoring \>24 on Standardized Mini Mental State Examination
* Modified Hoehn and Yahr stage 2-3
* No medication or dose changes during treatment
* Not participating in the physiotherapy and rehabilitation program in the last 6 months
* Volunteering to participate in the study

Exclusion Criteria:

* Vertebrobasilar insufficiency
* Other neurological diseases
* Postural hypotension, visual problems (which can not be compensated with the correct lens) or vestibular disorders that may affect balance
* Cardiopulmonary diseases that may affect gait
* Orthopedic problems (such as fracture, osteomyelitis, severe osteoporosis), advanced inflammatory arthritis, knee prothesis
* Uncontrolled dyskinesia or motor fluctuation
* Excessive use of alcohol or substance abuse
* Anticoagulant therapy, blood clotting diseases
* Long-term use of corticosteroids

Primary outcomes:
measure: Static Posturography Assesment (NeuroCom® Balance Master® Systems)
timeFrame: Baseline and immediately after cervical mobilization
measure: Dynamic Gait Index
timeFrame: Baseline and immediately after cervical mobilization
Secondary outcomes:
measure: Clinical Test of Sensory Integration on Balance
timeFrame: Baseline and immediately after cervical mobilization
measure: Functional Reach Test
timeFrame: Baseline and immediately after cervical mobilization
measure: Tandem Stance Balance Test
timeFrame: Baseline and immediately after cervical mobilization
Other outcomes:
measure: Mini-Mental State Examination
timeFrame: Baseline
measure: The Modified Hoehn and Yahr Scale
timeFrame: Baseline
measure: Unified Parkinson's Disease Rating Scale
timeFrame: Baseline
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Çankırı Karatekin University
name: Ayşenur Özcan, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Gül Yalçın Çakmaklı, Assoc. Prof
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Ayla Fil Balkan, Assoc. Prof
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Bülent Elibol, Prof. Dr.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Songül Aksoy, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Noll DR. Management of falls and balance disorders in the elderly. J Am Osteopath Assoc. 2013 Jan;113(1):17-22.
citation: Lopez D, King HH, Knebl JA, Kosmopoulos V, Collins D, Patterson RM. Effects of comprehensive osteopathic manipulative treatment on balance in elderly patients: a pilot study. J Am Osteopath Assoc. 2011 Jun;111(6):382-8. doi: 10.7556/jaoa.2011.111.6.382.
citation: Wells MR, Giantinoto S, D'Agate D, Areman RD, Fazzini EA, Dowling D, Bosak A. Standard osteopathic manipulative treatment acutely improves gait performance in patients with Parkinson's disease. J Am Osteopath Assoc. 1999 Feb;99(2):92-8. doi: 10.7556/jaoa.1999.99.2.92.
citation: Brink EE, Jinnai K, Hirai N, Wilson VJ. Cervical input to vestibulocollic neurons. Brain Res. 1981 Jul 27;217(1):13-21. doi: 10.1016/0006-8993(81)90181-5.
citation: Mergner T, Siebold C, Schweigart G, Becker W. Human perception of horizontal trunk and head rotation in space during vestibular and neck stimulation. Exp Brain Res. 1991;85(2):389-404. doi: 10.1007/BF00229416.
citation: Haavik-Taylor H, Murphy B. Cervical spine manipulation alters sensorimotor integration: a somatosensory evoked potential study. Clin Neurophysiol. 2007 Feb;118(2):391-402. doi: 10.1016/j.clinph.2006.09.014. Epub 2006 Nov 29.
citation: Haavik H, Murphy B. The role of spinal manipulation in addressing disordered sensorimotor integration and altered motor control. J Electromyogr Kinesiol. 2012 Oct;22(5):768-76. doi: 10.1016/j.jelekin.2012.02.012. Epub 2012 Apr 6.
citation: Holt KR, Haavik H, Elley CR. The effects of manual therapy on balance and falls: a systematic review. J Manipulative Physiol Ther. 2012 Mar-Apr;35(3):227-34. doi: 10.1016/j.jmpt.2012.01.007. Epub 2012 Feb 17.