Back to resultsThe Acute Effect of Cervical Mobilization in Parkinson's Disease
Primary Purpose
Idiopathic Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
cervical mobilization
control
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's disease, Cervical Spine, Postural Balance, Gait, Manual Therapies
Eligibility Criteria
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
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
control group
mobilization group
Arm Description
There was no intervention in the control group during the study (At the end of study all patients were received home-based exercise)
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)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04524143
Brief Title
The Acute Effect of Cervical Mobilization in Parkinson's Disease
Official Title
The Acute Effect of Cervical Mobilization on Balance and Gait in Patients With Idiopathic Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
December 28, 2020 (Actual)
Study Completion Date
December 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
Parkinson's disease, Cervical Spine, Postural Balance, Gait, Manual Therapies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Other
Arm Description
There was no intervention in the control group during the study (At the end of study all patients were received home-based exercise)
Arm Title
mobilization group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
cervical mobilization
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
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 Outcome Measure Information:
Title
Static Posturography Assesment (NeuroCom® Balance Master® Systems)
Description
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.
Time Frame
Baseline and immediately after cervical mobilization
Title
Dynamic Gait Index
Description
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.
Time Frame
Baseline and immediately after cervical mobilization
Secondary Outcome Measure Information:
Title
Clinical Test of Sensory Integration on Balance
Description
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
Time Frame
Baseline and immediately after cervical mobilization
Title
Functional Reach Test
Description
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.
Time Frame
Baseline and immediately after cervical mobilization
Title
Tandem Stance Balance Test
Description
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.
Time Frame
Baseline and immediately after cervical mobilization
Other Pre-specified Outcome Measures:
Title
Mini-Mental State Examination
Description
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.
Time Frame
Baseline
Title
The Modified Hoehn and Yahr Scale
Description
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.
Time Frame
Baseline
Title
Unified Parkinson's Disease Rating Scale
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşenur Özcan, MSc
Organizational Affiliation
Çankırı Karatekin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gül Yalçın Çakmaklı, Assoc. Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ayla Fil Balkan, Assoc. Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bülent Elibol, Prof. Dr.
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Songül Aksoy, Prof. Dr.
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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23329802
Citation
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Citation
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Results Reference
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PubMed Identifier
10079641
Citation
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Results Reference
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PubMed Identifier
6266589
Citation
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Results Reference
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1893987
Citation
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Results Reference
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PubMed Identifier
17137836
Citation
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Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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The Acute Effect of Cervical Mobilization in Parkinson's Disease
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