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

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Other: LSVT-BIG; Other: Traditional rehabilitation; Other: POWER

• Registration Number: NCT03212014
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-06
• Last Update Submitted: 2017-07-06
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LSVT-BIG	LSVT-BIG	Participants in this group would be treated with LSVT-BIG for three months
Traditional rehabilitation	Traditional rehabilitation	Participants in this group would be treated with traditional exercise rehabilitation for three months
POWER	POWER	Participants in this group would be treated with POWER for three months

Primary Outcome Measures

Name	Time	Method
mini-BESTest	15 mins	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

Name	Time	Method
Unified Parkinson's disease rating scale	15 mins	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	5 mins	Muscle power of knee flexion, extension. Measured by MicroFET
PDQ-39	30 mins	The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month

Trial Locations

Locations (1)

Taipei Veterans General Hospial; 🇨🇳 Taipei, Taiwan