Strategy for Daily Activity Improvement in Patients With... | NCT03972241

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

NCT03972241

Sponsor

Kwan-Hwa Lin

Status

Completed

Last Update Posted

Jun 3, 2019Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Parkinson Disease

Interventions

foot insole

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB103-42-A	Other Identifier	Buddhist Tzu Chi Hospital
IRB 103-173-A	Other Identifier	Buddhist Tzu Chi Hospital

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014Actual

Primary Completion Date

Jul 2016Actual

Completion Date

Dec 2017Actual

First Submitted Date

Jan 26, 2015

First Submission Date that Met QC Criteria

May 30, 2019

First Posted Date

Jun 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2019

Last Update Posted Date

Jun 3, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kwan-Hwa Lin, Department of Tzu Chi University, Buddhist Tzu Chi General HospitalSponsor-Investigator

Lead Sponsor

Kwan-Hwa LinOTHER

Collaborators

Name	Class
Buddhist Tzu Chi General Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	different interventions including foot insole or kinetic training	Device: foot insole
control	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
foot insole	Device	arch support and toe extension	Intervention	spiral drawing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ambulation	gait cycle	1 year

Secondary Outcomes

Measure	Description	Time Frame
Foot pressure	center of pressure	1 year
Spiral drawing	Figure plot	1 year

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kwan-Hwa Lin, PhD	Tzu Chi University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tzu Chi University		Hualien City	Hualien County	97004	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21474638	Background	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.
19884813	Background

ID	Term
D010300	Parkinson Disease
D014202	Tremor

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D009989	Orthotic Devices
D009983	Orthopedic Equipment
D013523	Surgical Equipment
D004864	Equipment and Supplies