Clinical trial NCT03212014: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
intelligent
Rehabilitaion
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2017-07-11
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: mini-BESTest
timeFrame: 15 mins
Secondary outcomes:
measure: Unified Parkinson's disease rating scale
timeFrame: 15 mins
measure: muscle power of lower extremity
timeFrame: 5 mins
measure: PDQ-39
timeFrame: 30 mins
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospial
Study officials:
References: