Core Stability and Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Core stability
Standard intervention
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Department of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Patients were included in a core stability intervention. It will be done with different stages and increasing gradually.
Standard intervention consisting of exercises aimed at improving balance.
Outcomes
Primary Outcome Measures
Change in dynamic balance
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.
Secondary Outcome Measures
Balance confidence
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.
Static balance
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.
Full Information
NCT ID
NCT03580096
First Posted
June 15, 2018
Last Updated
September 1, 2019
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT03580096
Brief Title
Core Stability and Parkinson Disease
Official Title
Effects of Core Stability Exercise in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 8, 2018 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
November 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients were included in a core stability intervention. It will be done with different stages and increasing gradually.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard intervention consisting of exercises aimed at improving balance.
Intervention Type
Other
Intervention Name(s)
Core stability
Other Intervention Name(s)
Core training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard intervention
Other Intervention Name(s)
Conventional intervention
Intervention Description
Standard intervention will include active exercises based on active joint mobilizations, muscle stretching and motor coordination.
Primary Outcome Measure Information:
Title
Change in dynamic balance
Description
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.
Time Frame
Change from baseline dynamic balance at 8 weeks
Secondary Outcome Measure Information:
Title
Balance confidence
Description
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.
Time Frame
Baseline, 8 weeks
Title
Static balance
Description
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.
Time Frame
Baseline, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Physical Therapy
City
Granada
ZIP/Postal Code
18071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Core Stability and Parkinson Disease
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