- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03580096
Core Stability and Parkinson Disease
September 1, 2019 updated by: Marie Carmen Valenza, Universidad de Granada
Effects of Core Stability Exercise in Patients With Parkinson's Disease
Patients with Parkinson's Disease frequently present impaired postural control that leads to loss of stability and increased risk of falls.Core system, includes passive structures of the thoracolumbar spine and pelvis that work as a unit to stabilize the body and spine against forces generated from distal body segments as well as forces generated from expected or unexpected perturbations.The objective of this study was to evaluate the effects of an intervention based on core stability in patients with Parkinson's Disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Core muscle coordination is important because lack of sufficient core muscle coordination can lead to decreased efficiency of postural control and functional activity.
Clinical manifestations of patients with Parkinson's Disease include postural instability.
Core system could be relevant to be included in an intervention.
Thus, the objective of this study was to evaluate the effects of an intervention based on core stability in patients with Parkinson's Disease.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Granada, Spain, 18071
- Department of Physical Therapy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parkinson's Disease diagnosis.
- Stable medication usage
- Able to maintain standing independent
Exclusion Criteria:
- Cognitive impairment
- Comprehension deficits that prevented them from following verbal commands
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental group
Patients were included in a core stability intervention.
It will be done with different stages and increasing gradually.
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Core stability intervention will be done with different stages and increasing gradually.
The training program starts with exercises that isolate specific core muscles but progressing to include complex movements and incorporate core stability in dynamic tasks.
Other Names:
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ACTIVE_COMPARATOR: Control group
Standard intervention consisting of exercises aimed at improving balance.
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Standard intervention will include active exercises based on active joint mobilizations, muscle stretching and motor coordination.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in dynamic balance
Time Frame: Change from baseline dynamic balance at 8 weeks
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Dynamic balance is going to be assessed with the Mini-Balance Evaluation System Test.
It was developed to identify the postural control systems that underly poor functional balance.
It contains four subscales: anticipatory postural control, reactive postural control, sensory orientation and stability in gait.
It includes 14 items scored on a 3 level ordinal scale.
The maximum total score is 28 points with higher scores indicating better balance.
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Change from baseline dynamic balance at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance confidence
Time Frame: Baseline, 8 weeks
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The perceived level of balance confidence is going to be assessed using the Activities-Specific Balance Confidence Scale (ABC).
There are 16 items, representing daily activities.
Participants are asked to answer, with a score from 0% (not confident at all) to 100% (completely confident) in increments of 10%.
A score lower than 67% suggests substantial risk of falling.
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Baseline, 8 weeks
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Static balance
Time Frame: Baseline, 8 weeks
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Static balance is going to be assessed using the Wii Balance Board.The 4 sensors in the balance board can sense weight changes and show the distribution of body weight.
It will be assessed standing balance with eyes opened and closed, and standing over a foam with eyes opened and closed.
Higher time in a stable position indicates greater static balance.
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Baseline, 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 8, 2018
Primary Completion (ACTUAL)
September 20, 2018
Study Completion (ACTUAL)
November 4, 2018
Study Registration Dates
First Submitted
June 15, 2018
First Submitted That Met QC Criteria
July 5, 2018
First Posted (ACTUAL)
July 9, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 4, 2019
Last Update Submitted That Met QC Criteria
September 1, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF0074UG
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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