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Idiopathic Parkinson's DiseaseNCT04524143

The Acute Effect of Cervical Mobilization in Parkinson's Disease

A study testing cervical mobilization in people with Idiopathic Parkinson's Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Idiopathic Parkinson's Disease
What is being tested?
cervical mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Sep 2020to 28 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Excessive use of alcohol or substance abuse
  • Anticoagulant therapy, blood clotting diseases
  • Long-term use of corticosteroids

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hacettepe University

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
cervical mobilization, control
Keywords
Parkinson's disease, Cervical Spine, Postural Balance, Gait, Manual Therapies
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cervical mobilizationOther

    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

  • 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

Study groups in NCT04524143
Study groupRoleWhat they receive
control groupOtherThere was no intervention in the control group during the study (At the end of study all patients were received home-based exercise)
Receives: Other: control
mobilization groupExperimentalCervical 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)
Receives: Other: cervical mobilization; Other: control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and immediately after cervical mobilization

  2. 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.

    Measured: Baseline and immediately after cervical mobilization

Secondary outcomes (3)

  1. 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

    Measured: Baseline and immediately after cervical mobilization

  2. 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.

    Measured: Baseline and immediately after cervical mobilization

  3. 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.

    Measured: Baseline and immediately after cervical mobilization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2020
  2. Study start2 Sep 2020
  3. Primary completion28 Dec 2020
  4. Study completion28 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized controlled
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04524143
Sponsor's protocol ID
KA-180099
Status last verified
Oct 2021
First submitted
18 Aug 2020
Last updated
21 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 23329802

  • 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.

    PubMed 21771924

  • 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.

    PubMed 10079641

  • 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.

    PubMed 6266589

  • 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.

    PubMed 1893987

  • 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.

    PubMed 17137836

  • 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.

    PubMed 22483612

  • 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.

    PubMed 22343006

Questions about this trial

What is this clinical trial studying?

A study testing cervical mobilization in people with Idiopathic Parkinson's Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Static Posturography Assesment (NeuroCom® Balance Master® Systems) (time frame: Baseline and immediately after cervical mobilization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04524143, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.

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