Strategy for Daily Activity Improvement in Patients With Parkinson's Disease (Parkinson)

May 30, 2019 updated by: Kwan-Hwa Lin

Three Dimensional Motion Analysis of Daily Activities With Functional Insole in Parkinsonian Patients

The symptoms and signs of patients with Parkinson's disease (PD) include bradykinesia, rigidity, tremor and poor sensory integration, which result in mobility disability. Present integrated research project tries to investigate the effects of different physical therapy interventions on daily activities in patients with PD. This integrated research project includes 3 subprojects as follows. The title of Subproject 1 is "Three dimensional motion analysis of daily activities with functional insole in Parkinsonian patients". The title of Subproject 2 is "Immediate and long-term effects of novel plantar mechanical device on postural control in standing and gait performance in people with Parkinson's disease". The title of Subproject 3 is "Upper extremity hand function and coordination during functional movement in patients with Parkinson's disease".

This multidisciplinary research project collaborates with Department of Physical Therapy, and Department of Medicine in Tzu Chi University. Furthermore, this integrated study also works with Department of Neurology, Department of Neurosurgery, as well as Department of Rehabilitation in Tzu Chi Hospital to improve the mobility in patients with PD.

This is a three-year integrated project, and the common purposes of this project in each are as follows. In the first year, it is to compare the daily functional difference between the healthy and the Parkinsonian patients. In the second year, it is to examine the immediate and short-term effects of different interventions on daily activities in Parkinsonian patients.The third year is for upper extremity functional assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the first year, it is to compare the functional difference of biomechanics and motor control between the healthy and the Parkinsonian patients. In the second year, it is to examine the immediate and short-term effects of functional foot insole and the kinetic training on daily activities in Parkinsonian patients. In the third year, it is to examine the hand tremor during drawing, and the coordination during reaching in Parkinsonian patients.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Hualien County
      • Hualien City, Hualien County, Taiwan, 97004
        • Tzu Chi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage II~IV of Hoehn and Yahr Staging of Parkinson's Disease and normal subjects, whose age between 40~75.

Exclusion Criteria:

  • Brain injury or hemorrhage, including stroke, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
No intervention
Experimental: Intervention
different interventions including foot insole or kinetic training
Device: foot insole
arch support and toe extension
Other Names:
  • spiral drawing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ambulation
Time Frame: 1 year
gait cycle
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot pressure
Time Frame: 1 year
center of pressure
1 year
Spiral drawing
Time Frame: 1 year
Figure plot
1 year
Coordination
Time Frame: 1 year
Reaching movement
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kwan-Hwa Lin

Collaborators

Buddhist Tzu Chi General Hospital

Investigators

  • Principal Investigator: Kwan-Hwa Lin, PhD, Tzu Chi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

May 30, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Actual)

June 3, 2019

Last Update Submitted That Met QC Criteria

May 30, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB103-43-A
  • IRB103-42-A (Other Identifier: Buddhist Tzu Chi Hospital)
  • IRB 103-173-A (Other Identifier: Buddhist Tzu Chi Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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