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出境医 / 临床实验 / Strategy for Daily Activity Improvement in Patients With Parkinson's Disease (Parkinson)

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

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Device: foot insole Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: To compare between experimental and control groups.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Three Dimensional Motion Analysis of Daily Activities With Functional Insole in Parkinsonian Patients
Actual Study Start Date : August 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2017
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention
different interventions including foot insole or kinetic training
 Device: foot insole
arch support and toe extension
Other Name: spiral drawing
No Intervention: control
No intervention
Outcome Measures
Primary Outcome Measures :
  1. Ambulation [ Time Frame: 1 year ]
    gait cycle


Secondary Outcome Measures :
  1. Foot pressure [ Time Frame: 1 year ]
    center of pressure

  2. Spiral drawing [ Time Frame: 1 year ]
    Figure plot

  3. Coordination [ Time Frame: 1 year ]
    Reaching movement


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Locations
Layout table for location information
Taiwan
Tzu Chi University
Hualien City, Hualien County, Taiwan, 97004
Sponsors and Collaborators
Kwan-Hwa Lin
Buddhist Tzu Chi General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Kwan-Hwa Lin, PhD Tzu Chi University
Tracking Information
First Submitted Date  ICMJE January 26, 2015
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE August 2014
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019) 		Ambulation [ Time Frame: 1 year ]
gait cycle
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • Foot pressure [ Time Frame: 1 year ]
    center of pressure
  • Spiral drawing [ Time Frame: 1 year ]
    Figure plot
  • Coordination [ Time Frame: 1 year ]
    Reaching movement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strategy for Daily Activity Improvement in Patients With Parkinson's Disease
Official Title  ICMJE Three Dimensional Motion Analysis of Daily Activities With Functional Insole in Parkinsonian Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
To compare between experimental and control groups.
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Device: foot insole
arch support and toe extension
Other Name: spiral drawing
Study Arms  ICMJE
  • Experimental: Intervention
    different interventions including foot insole or kinetic training
    Intervention: Device: foot insole
  • No Intervention: control
    No intervention
Publications *
  • 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.
  • 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.
  • 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. Epub 2005 Nov 21.
  • 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. Review.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2019) 		60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972241
Other Study ID Numbers  ICMJE IRB103-43-A
IRB103-42-A ( Other Identifier: Buddhist Tzu Chi Hospital )
IRB 103-173-A ( Other Identifier: Buddhist Tzu Chi Hospital )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kwan-Hwa Lin, Buddhist Tzu Chi General Hospital
Study Sponsor  ICMJE Kwan-Hwa Lin
Collaborators  ICMJE Buddhist Tzu Chi General Hospital
Investigators  ICMJE
Principal Investigator: Kwan-Hwa Lin, PhD Tzu Chi University
PRS Account Buddhist Tzu Chi General Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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