NCT03580096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

July 8, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2018

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

June 15, 2018

Last Update Submit

September 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Balance confidence

    Baseline, 8 weeks

  • Static balance

    Baseline, 8 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients were included in a core stability intervention. It will be done with different stages and increasing gradually.

Other: Core stability

Control group

ACTIVE COMPARATOR

Standard intervention consisting of exercises aimed at improving balance.

Other: Standard intervention

Interventions

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.

Also known as: Core training
Experimental group

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

Also known as: Conventional intervention
Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's Disease diagnosis.
  • Stable medication usage
  • Able to maintain standing independent

You may not qualify if:

  • Cognitive impairment
  • Comprehension deficits that prevented them from following verbal commands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Granada, 18071, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Core Stability

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Postural BalanceProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensationNervous System Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 15, 2018

First Posted

July 9, 2018

Study Start

July 8, 2018

Primary Completion

September 20, 2018

Study Completion

November 4, 2018

Last Updated

September 4, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations