The Acute Effect of Cervical Mobilization in Parkinson's Disease

The Acute Effect of Cervical Mobilization on Balance and Gait in Patients With Idiopathic Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Parkinson's Disease
• Intervention / Treatment: Other: control; Other: cervical mobilization

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group; There was no intervention in the control group during the study (At the end of study all patients were received home-based exercise)	Other: control; 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
Experimental: mobilization group; Cervical 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)	Other: control; 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; Other: cervical mobilization; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Test of Sensory Integration on Balance	In this clinical test, which evaluates the static balance in the standing posture, there are 6 different parameters that are formed by a combination of three visual (eyes open, eyes closed and DOME) and two support surfaces (firm and foam floor). Oscillations are observed during the evaluation and it is expected to maintain each test position for 30 seconds	Baseline and immediately after cervical mobilization
Functional Reach Test	It is used to evaluate dynamic equilibrium and anteroposterior stability. Test is performed with the participant in standing. It is the measure of the difference between arm's length with arms at 90° flexion and maximal forward reach. A score between 6-10 inches indicates a moderate risk for falls.	Baseline and immediately after cervical mobilization
Tandem Stance Balance Test	In the tandem position, a person places one foot in front of the other and tries to maintain its balance in this position. The stance time is recorded.	Baseline and immediately after cervical mobilization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination	The Mini-Mental Status Examination offers a quick and simple way to quantify cognitive function and screen for cognitive loss.It tests the individual's orientation, attention, calculation, recall, language and motor skills. Each section of the test involves a related series of questions or commands. The individual receives one point for each correct answer. To give the examination, seat the individual in a quiet, well-lit room. Ask him/her to listen carefully and to answer each question as accurately as he/she can. Don't time the test but score it right away. To score, add the number of correct responses. The individual can receive a maximum score of 30 points. A score below 20 usually indicates cognitive impairment.	Baseline
The Modified Hoehn and Yahr Scale	It is used to describe the symptom progression of Parkinson disease. It was designed to be a descriptive staging scale to evaluate both disability and impairment related to clinical disease progression. It was originally published in 1967 and included stages 1 through 5. Since then, a modified Hoehn and Yahr scale was proposed with the addition of stages 1.5 and 2.5 to help describe the intermediate course of the disease. Modified Hoehn and Yahr Staging STAGE 0 = No signs of disease. STAGE 1 = Unilateral disease. STAGE 1.5 = Unilateral plus axial involvement. STAGE 2 = Bilateral disease, without impairment of balance. STAGE 2.5 = Mild bilateral disease, with recovery on pull test. STAGE 3 = Mild to moderate bilateral disease; some postural instability; physically independent. STAGE 4 = Severe disability; still able to walk or stand unassisted. STAGE 5 = Wheelchair bound or bedridden unless aided.	Baseline
Unified Parkinson's Disease Rating Scale	It is used to evaluate the symptoms of the disease and complications related to treatment. In this scale consisting of 4 parts, the scoring of each item is between 0-4 points. (I = Mental state, behavior and mental state, II = Activities of daily living, III = Motor examination, IV = Treatment complications). Parts I to III are scored on a 0-4 rating scale. Part IV is scored with yes and no ratings. Higher scores indicate increased severity.	Baseline

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Chair: Ayla Fil Balkan, Assoc. Prof, Hacettepe University; Study Chair: Bülent Elibol, Prof. Dr., Hacettepe University; Study Director: Gül Yalçın Çakmaklı, Assoc. Prof, Hacettepe University; Study Chair: Songül Aksoy, Prof. Dr., Hacettepe University; Principal Investigator: Ayşenur Özcan, MSc, Çankırı Karatekin University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Noll DR. Management of falls and balance disorders in the elderly. J Am Osteopath Assoc. 2013 Jan;113(1):17-22.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): December 28, 2020
• Study Completion (Actual): December 28, 2020

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Gait; Parkinson's disease; Postural Balance; Manual Therapies; Cervical Spine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: KA-180099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No