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Development and Research of an Individualized Intelligent Platform for Rehabilitaion in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
LSVT-BIG
POWER
Traditional rehabilitation
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, intelligent, Rehabilitaion

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. .Parkinson's disease diagnosis, Hoehn-Yahr level I-III
  2. .Stable medicine intake for 2 weeks at least
  3. .Able to walk independently for 15 meters
  4. .Aged 40-85 years old

Exclusion Criteria:

  1. .Cognition deficits(MMSE score<24)
  2. .Combined other neurological disease, such as stork, SCI, and so on.
  3. .Pregnant or Breastfeeding

Sites / Locations

  • Taipei Veterans General HospialRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

LSVT-BIG

POWER

Traditional rehabilitation

Arm Description

Participants in this group would be treated with LSVT-BIG for three months

Participants in this group would be treated with POWER for three months

Participants in this group would be treated with traditional exercise rehabilitation for three months

Outcomes

Primary Outcome Measures

mini-BESTest
Mini BESTest assesses dynamic balance, a unidimensinal construct and includes 14 items addressing 4 of the 6 sections of the original BESTest (anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait).

Secondary Outcome Measures

Unified Parkinson's disease rating scale
The unified Parkinson's disease rating scale (UPDRS) is used to follow the longitudinal course of Parkinson's disease. The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease.
muscle power of lower extremity
Muscle power of knee flexion, extension. Measured by MicroFET
PDQ-39
The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month

Full Information

First Posted
July 6, 2017
Last Updated
July 6, 2017
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03212014
Brief Title
Development and Research of an Individualized Intelligent Platform for Rehabilitaion in Parkinson's Disease
Official Title
Development and Research of an Individualized Intelligent Platform for Rehabilitaion in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The present study aims to compare the clinical efficacy of intelligent POWER therapy, intelligent LSVT-BIG therapy, and the three exercise models currently in clinical use. DCM_IR analysis will also be incorporated into the analysis to develop a personalized and intelligent Parkinson's rehabilitative therapy platform.
Detailed Description
Background: Parkinson's disease is a progressively degenerative disorder. Patients need early screening, therapeutic intervention, and personalized interaction with outpatient rehabilitative treatment. In the past, it had been difficult to meet these goals. Recent advances in bio-sensors technology has enabled collection of bio-metric data. Models of brainwave analysis have also matured. In addition, our ability to analyze vibrational spectrogram had also greatly improved. How to combine these enabling technologies to meet the needs of Parkinson's patients is an urgent topic of research. Objective: The present study aims to compare the clinical efficacy of intelligent POWER therapy, intelligent LSVT-BIG therapy, and the three exercise models currently in clinical use. DCM_IR analysis will also be incorporated into the analysis to develop a personalized and intelligent Parkinson's rehabilitative therapy platform. Method: Patients will be randomly assigned into three groups, i.e. intelligent POWER, intelligent LSVT-BIG, and current protocol group. Single blind data collection will be used. Patients will be evaluated immediately before treatment, immediately after treatment, and 4 weeks after treatment. Evaluated criteria will include mini-BESTest, Unified Parkinson's disease rating scale, muscle power of lower extremity, time up and go, walk velocity, step length, cadence, and Parkinson's disease questionnaire PDQ-39. Expected Outcome: An intelligent rehabilitative therapy platform may be built on the sensor data and neural-network analysis of the data. The platform will enable patients to interact with medical personnel on out-patient basis. If further combined with DCM_IR analysis, personalized therapeutic efficacy indicator may be uncovered, thereby, realizing intelligent personalized rehabilitative therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, intelligent, Rehabilitaion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LSVT-BIG
Arm Type
Experimental
Arm Description
Participants in this group would be treated with LSVT-BIG for three months
Arm Title
POWER
Arm Type
Experimental
Arm Description
Participants in this group would be treated with POWER for three months
Arm Title
Traditional rehabilitation
Arm Type
Active Comparator
Arm Description
Participants in this group would be treated with traditional exercise rehabilitation for three months
Intervention Type
Other
Intervention Name(s)
LSVT-BIG
Intervention Description
LSVT BIG can be delivered by a physical or occupational therapist. Treatment is administered in 16 sessions over a single month (four individual 60 minute sessions per week). This protocol was developed specifically to address the unique movement impairments for people with Parkinson disease. The protocol is both intensive and complex, with many repetitions of core movements that are used in daily living. This type of practice is necessary to optimize learning and carryover of your better movement into everyday life!
Intervention Type
Other
Intervention Name(s)
POWER
Intervention Description
Power Rehabilitation(PR), a new resistance training regime, can improve in power and independence level of the elderly people. The first word of PR was in brief of Produce Outcome Worthwhile for the Elderly Rehabilitation (POWER)
Intervention Type
Other
Intervention Name(s)
Traditional rehabilitation
Intervention Description
traditional exercise models in currently clinical use
Primary Outcome Measure Information:
Title
mini-BESTest
Description
Mini BESTest assesses dynamic balance, a unidimensinal construct and includes 14 items addressing 4 of the 6 sections of the original BESTest (anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait).
Time Frame
15 mins
Secondary Outcome Measure Information:
Title
Unified Parkinson's disease rating scale
Description
The unified Parkinson's disease rating scale (UPDRS) is used to follow the longitudinal course of Parkinson's disease. The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease.
Time Frame
15 mins
Title
muscle power of lower extremity
Description
Muscle power of knee flexion, extension. Measured by MicroFET
Time Frame
5 mins
Title
PDQ-39
Description
The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month
Time Frame
30 mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: .Parkinson's disease diagnosis, Hoehn-Yahr level I-III .Stable medicine intake for 2 weeks at least .Able to walk independently for 15 meters .Aged 40-85 years old Exclusion Criteria: .Cognition deficits(MMSE score<24) .Combined other neurological disease, such as stork, SCI, and so on. .Pregnant or Breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Si-Huei Lee
Phone
+886-2-28712121
Ext
2931
Email
lableesihuei@gmail.com
Facility Information:
Facility Name
Taipei Veterans General Hospial
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Si-Huei Lee
Phone
+886-2-28712121
Ext
2931
Email
lableesihuei@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Development and Research of an Individualized Intelligent Platform for Rehabilitaion in Parkinson's Disease

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