NCT01989013

Brief Summary

We are studying \& researching the effect of CranioSacral Integrative therapy on Parkinson's Diseased Patients for 3 months. With a therapeutic induction via manual CranioSacral integrative therapy for 90 minutes per session with a total of 2 session divided equally in a month (biweekly intervention). At the end of 3 months each patient will have total of 9 hours of CranioSacral Integrative therapy induced, we will document the symptoms and shortcomings of the patients at evaluation, before and after therapeutic treatment on a measured scale ranging from 1-10. Finally graphically and statistically measure the quality of change in the symptoms at the end of 3 months and provide executive summary of the research finding, which the investigators expect to be a positive one.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

November 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

11.1 years

First QC Date

November 14, 2013

Last Update Submit

January 21, 2025

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseCraniosacral therapycranial osteopathy

Outcome Measures

Primary Outcomes (1)

  • reduction in tremors due to Parkinson's disease in the patient

    Measurement of the tremors and quality of the coordination of the medial leminiscus system on 1-10 (1 being zero tremors and 10 being out of control tremors) scale at the evaluation and at beginning and at the end of each treatment session and in the end will provide a graphical and statistical display in the change in the tremors relative to the therapeutic induction

    3 months

Secondary Outcomes (1)

  • Quality of Proprioception

    3 months

Other Outcomes (1)

  • Overall emotional State and sleep quality

    3 months

Study Arms (1)

biweekly intervention

OTHER

biweekly intervention

Other: biweekly intervention

Interventions

biweekly interventionOTHER

10 step craniosacral therapy protocol through manual therapy at feet , thoracic diaphragm, neck and cranium

Also known as: manual therapy
biweekly intervention

Eligibility Criteria

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

You may qualify if:

  • must be Diagnosed with Parkinson's Disease

You may not qualify if:

  • Anyone without Parkinson's Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naturalmed therapy

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Al Raza, CST

    IBR, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2013

First Posted

November 20, 2013

Study Start

February 1, 2014

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)