NCT04524143

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

September 2, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2020

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

August 18, 2020

Last Update Submit

October 14, 2021

Conditions

Keywords

Parkinson's diseaseCervical SpinePostural BalanceGaitManual Therapies

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

OTHER

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

mobilization group

EXPERIMENTAL

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: cervical mobilizationOther: control

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

mobilization group
controlOTHER

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

control groupmobilization group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 23329802BACKGROUND
  • 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.

    PMID: 21771924BACKGROUND
  • 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.

    PMID: 10079641BACKGROUND
  • 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.

    PMID: 6266589BACKGROUND
  • 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.

    PMID: 1893987BACKGROUND
  • 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.

    PMID: 17137836BACKGROUND
  • 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.

    PMID: 22483612BACKGROUND
  • 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.

    PMID: 22343006BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Ayşenur Özcan, MSc

    Çankırı Karatekin University

    PRINCIPAL INVESTIGATOR
  • Gül Yalçın Çakmaklı, Assoc. Prof

    Hacettepe University

    STUDY DIRECTOR
  • Ayla Fil Balkan, Assoc. Prof

    Hacettepe University

    STUDY CHAIR
  • Bülent Elibol, Prof. Dr.

    Hacettepe University

    STUDY CHAIR
  • Songül Aksoy, Prof. Dr.

    Hacettepe University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled
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

Locations