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

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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: LSVT-BIG; Other: POWER; Other: Traditional rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Veterans General Hospial
    • Contact: Si-Huei Lee; Phone Number: 2931 +886-2-28712121; Email: lableesihuei@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LSVT-BIG; Participants in this group would be treated with LSVT-BIG for three months	Other: 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!
EXPERIMENTAL: POWER; Participants in this group would be treated with POWER for three months	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)
ACTIVE_COMPARATOR: Traditional rehabilitation; Participants in this group would be treated with traditional exercise rehabilitation for three months	Other: Traditional rehabilitation; traditional exercise models in currently clinical use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	15 mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 mins
muscle power of lower extremity	Muscle power of knee flexion, extension. Measured by MicroFET	5 mins
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	30 mins

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ANTICIPATED): December 31, 2017
• Study Completion (ANTICIPATED): December 31, 2017

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (ACTUAL): July 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Parkinson Disease; intelligent; Rehabilitaion
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2016-09-018C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No