The Acute Effect of Cervical Mobilization in Parkinson's Disease
1 other identifier
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2020
CompletedFirst Posted
Study publicly available on registry
August 24, 2020
CompletedStudy Start
First participant enrolled
September 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2020
CompletedOctober 21, 2021
October 1, 2021
4 months
August 18, 2020
October 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Static Posturography Assesment (NeuroCom® Balance Master® Systems)
Posturography measures postural stability statically and dynamically. Device has lots of test parameters such as Modified Clinical Test of Sensory Integration on Balance Test, limits of stability, rhythmic weight shift, weight bearing squat, unilateral stance, sit to stand, walk across, tandem walk, step/quick turn, step up/over and forward lunge. In addition to assesment, exercise training can also be given by posturography.
Baseline and immediately after cervical mobilization
Dynamic Gait Index
It is a measurement tool that can be used to assess dynamic balance, gait, and risk for falls. Balance and walking pattern changes are scored during tasks such as changing gait speed, gait with vertical and horizontal head turns, pivot turn, step over obstacle, step around obstacles and climbing stairs. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function.Total score is 24 for this scale.
Baseline and immediately after cervical mobilization
Secondary Outcomes (3)
Clinical Test of Sensory Integration on Balance
Baseline and immediately after cervical mobilization
Functional Reach Test
Baseline and immediately after cervical mobilization
Tandem Stance Balance Test
Baseline and immediately after cervical mobilization
Other Outcomes (3)
Mini-Mental State Examination
Baseline
The Modified Hoehn and Yahr Scale
Baseline
Unified Parkinson's Disease Rating Scale
Baseline
Study Arms (2)
control group
OTHERThere was no intervention in the control group during the study (At the end of study all patients were received home-based exercise)
mobilization group
EXPERIMENTALCervical mobilization was applied to the mobilization group. Cervical mobilization techniques were applied for 10 minutes in the supine position. (At the end of study all patients were received home- based exercise)
Interventions
Cervical mobilization techniques were applied in the study. Within the scope of application; rotation with traction, lateral gliding, anterior-posterior gliding with traction, bridging and stroking techniques to the paravertebral muscles were used. Mobilization were performed at grade A (mobilization in painless joint range) and grade B (continuous stretching at the end of the joint range). The mobilization were applied during 10 minutes. At the end of study all patients were received home-based exercise tailored to each individual's needs which include stretching, strengthening, balance and gait exercise and posture exercise
There was no intervention in the control group during study. At the end of study all patients were received home-based exercise tailored to each individual's needs which include stretching, strengthening, balance and gait exercise and posture exercise
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, 06100, Turkey (Türkiye)
Related Publications (8)
Noll DR. Management of falls and balance disorders in the elderly. J Am Osteopath Assoc. 2013 Jan;113(1):17-22.
PMID: 23329802BACKGROUNDLopez 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.
PMID: 21771924BACKGROUNDWells 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.
PMID: 10079641BACKGROUNDBrink 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.
PMID: 6266589BACKGROUNDMergner 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.
PMID: 1893987BACKGROUNDHaavik-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.
PMID: 17137836BACKGROUNDHaavik 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.
PMID: 22483612BACKGROUNDHolt 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.
PMID: 22343006BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayşenur Özcan, MSc
Çankırı Karatekin University
- STUDY DIRECTOR
Gül Yalçın Çakmaklı, Assoc. Prof
Hacettepe University
- STUDY CHAIR
Ayla Fil Balkan, Assoc. Prof
Hacettepe University
- STUDY CHAIR
Bülent Elibol, Prof. Dr.
Hacettepe University
- STUDY CHAIR
Songül Aksoy, Prof. Dr.
Hacettepe University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
August 18, 2020
First Posted
August 24, 2020
Study Start
September 2, 2020
Primary Completion
December 28, 2020
Study Completion
December 28, 2020
Last Updated
October 21, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share