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

NCT ID: NCT03212014

Last Updated: 2017-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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LSVT-BIG

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

Group Type EXPERIMENTAL

LSVT-BIG

Intervention Type OTHER

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!

POWER

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

Group Type EXPERIMENTAL

POWER

Intervention Type OTHER

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)

Traditional rehabilitation

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

Group Type ACTIVE_COMPARATOR

Traditional rehabilitation

Intervention Type OTHER

traditional exercise models in currently clinical use

Interventions

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LSVT-BIG

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

POWER

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

Traditional rehabilitation

traditional exercise models in currently clinical use

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Veterans General Hospial

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Si-Huei Lee

Role: CONTACT

+886-2-28712121 ext. 2931

Facility Contacts

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Si-Huei Lee

Role: primary

+886-2-28712121 ext. 2931

References

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Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

Reference Type DERIVED
PMID: 38588457 (View on PubMed)

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

Reference Type DERIVED
PMID: 36602886 (View on PubMed)

Other Identifiers

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2016-09-018C

Identifier Type: -

Identifier Source: org_study_id

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