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Completed

NCT Number: NCT04524143

The Acute Effect of Cervical Mobilization in 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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cervical mobilization

Other

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

Control

Other

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

Primary outcomes

  1. Static Posturography Assesment (NeuroCom® Balance Master® Systems)

    Time frame: Baseline and immediately after cervical mobilization

    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.

  2. Dynamic Gait Index

    Time frame: Baseline and immediately after cervical mobilization

    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.

Secondary outcomes

  1. Clinical Test of Sensory Integration on Balance

    Time frame: Baseline and immediately after cervical mobilization

    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

  2. Functional Reach Test

    Time frame: Baseline and immediately after cervical mobilization

    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.

  3. Tandem Stance Balance Test

    Time frame: Baseline and immediately after cervical mobilization

    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.

Other outcomes

  1. Mini-Mental State Examination

    Time frame: Baseline

    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.

  2. The Modified Hoehn and Yahr Scale

    Time frame: Baseline

    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.

  3. Unified Parkinson's Disease Rating Scale

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 24, 2020
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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