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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03580096
Other study ID # DF0074UG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 8, 2018
Est. completion date November 4, 2018

Study information

Verified date September 2019
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date November 4, 2018
Est. primary completion date September 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Core stability
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.
Standard intervention
Standard intervention will include active exercises based on active joint mobilizations, muscle stretching and motor coordination.

Locations

Country Name City State
Spain Department of Physical Therapy Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline dynamic balance at 8 weeks
Secondary 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. Baseline, 8 weeks
Secondary 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. Baseline, 8 weeks
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