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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
foot insole
Sponsored by
Kwan-Hwa Lin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Quality of life, Physical therapy, tremor, coordination, gait analysis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tzu Chi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

control

Arm Description

different interventions including foot insole or kinetic training

No intervention

Outcomes

Primary Outcome Measures

Ambulation
gait cycle

Secondary Outcome Measures

Foot pressure
center of pressure
Spiral drawing
Figure plot
Coordination
Reaching movement

Full Information

First Posted
January 26, 2015
Last Updated
May 30, 2019
Sponsor
Kwan-Hwa Lin
Collaborators
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03972241
Brief Title
Strategy for Daily Activity Improvement in Patients With Parkinson's Disease
Acronym
Parkinson
Official Title
Three Dimensional Motion Analysis of Daily Activities With Functional Insole in Parkinsonian Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kwan-Hwa Lin
Collaborators
Buddhist Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, Quality of life, Physical therapy, tremor, coordination, gait analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
To compare between experimental and control groups.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
different interventions including foot insole or kinetic training
Arm Title
control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Device
Intervention Name(s)
foot insole
Other Intervention Name(s)
spiral drawing
Intervention Description
arch support and toe extension
Primary Outcome Measure Information:
Title
Ambulation
Description
gait cycle
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Foot pressure
Description
center of pressure
Time Frame
1 year
Title
Spiral drawing
Description
Figure plot
Time Frame
1 year
Title
Coordination
Description
Reaching movement
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwan-Hwa Lin, PhD
Organizational Affiliation
Tzu Chi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tzu Chi University
City
Hualien City
State/Province
Hualien County
ZIP/Postal Code
97004
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21474638
Citation
Yen CY, Lin KH, Hu MH, Wu RM, Lu TW, Lin CH. Effects of virtual reality-augmented balance training on sensory organization and attentional demand for postural control in people with Parkinson disease: a randomized controlled trial. Phys Ther. 2011 Jun;91(6):862-74. doi: 10.2522/ptj.20100050. Epub 2011 Apr 7.
Results Reference
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PubMed Identifier
19884813
Citation
Chen CH, Lin KH, Lu TW, Chai HM, Chen HL, Tang PF, Hu MH. Immediate effect of lateral-wedged insole on stance and ambulation after stroke. Am J Phys Med Rehabil. 2010 Jan;89(1):48-55. doi: 10.1097/PHM.0b013e3181c1ea8a.
Results Reference
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PubMed Identifier
16300949
Citation
Myers KA, Long JT, Klein JP, Wertsch JJ, Janisse D, Harris GF. Biomechanical implications of the negative heel rocker sole shoe: gait kinematics and kinetics. Gait Posture. 2006 Nov;24(3):323-30. doi: 10.1016/j.gaitpost.2005.10.006. Epub 2005 Nov 21.
Results Reference
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PubMed Identifier
11427288
Citation
Morris ME, Huxham F, McGinley J, Dodd K, Iansek R. The biomechanics and motor control of gait in Parkinson disease. Clin Biomech (Bristol, Avon). 2001 Jul;16(6):459-70. doi: 10.1016/s0268-0033(01)00035-3.
Results Reference
background
PubMed Identifier
16571399
Citation
Lee HJ, Chou LS. Detection of gait instability using the center of mass and center of pressure inclination angles. Arch Phys Med Rehabil. 2006 Apr;87(4):569-75. doi: 10.1016/j.apmr.2005.11.033.
Results Reference
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Strategy for Daily Activity Improvement in Patients With Parkinson's Disease

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