NCT00869830

Brief Summary

The aims of the investigators' study are to characterize the nature of constipation in idiopathic Parkinson's disease (IPD) and to evaluate the usefulness of biofeedback therapy in constipated IPD patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

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

Study Start

First participant enrolled

January 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

Enrollment Period

1.6 years

First QC Date

March 25, 2009

Last Update Submit

March 25, 2009

Conditions

Idiopathic Parkinson's DiseaseConstipation

Keywords

BiofeedbackconstipationParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effectiveness of biofeedback therapy in Parkinson's disease

    usually six sessions per one biofeedback for 3 months

Secondary Outcomes (1)

  • to evaluate the constipation type in Parkinson's disease

    3-6 months

Study Arms (1)

biofeedback

EXPERIMENTAL
Other: biofeedback therapy

Interventions

biofeedback therapyOTHER

biofeedback therapy was applied using the surface electromyography (EMG) method with a perianal sensor (Perry, Elan, SRS Medical Systems, Redmond, WA, USA) and biofeedback PC equipment (Orion, Platinum, SRS Medical Systems, Inc., Redmond, WA, USA).

Also known as: perianal sensor (Perry, Elan, SRS Medical Systems, Redmond, WA, USA), biofeedback PC equipment (Orion, Platinum, SRS Medical Systems, Inc., Redmond, WA, USA).
biofeedback

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's disease

You may not qualify if:

  • Secondary Parkinson's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seung-Jae, Myung

Seoul, Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Parkinson DiseaseConstipation

Interventions

Biofeedback, PsychologyPlatinum

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Kee Wook Jung, M.D.

    Asan Digestive Disease Research Institute, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

January 1, 2007

Primary Completion

August 1, 2008

Last Updated

March 26, 2009

Record last verified: 2009-03

Locations

KR(1)