The Efficacy of Online Exergaming-Integrated Physiotherapy for Parkinson's Disease

Assessing the Efficacy of Online Exergaming-Integrated Physiotherapy for Parkinson's Disease: A Validation Study

To validate the efficiency of online exergaming-based physiotherapy. We will enroll patients with Parkinson's disease in postural instability and gait disturbance motor phenotype in the study and divide them into two groups in a randomized controlled study.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinsonism in Diseases Classified Elsewhere
• Intervention / Treatment: Other: online exergaming-based physiotherapy programs

Detailed Description

The investigators will enroll patients in PIGD and divide them into two groups in a randomized controlled study. Participants received an exergaming intervention using the Kinect sensor (Microsoft Corporation, Redmond, WA, USA) from a commercially available exercise system (HappyGoGo, LONGGOOD MEDITECH LTD., Taipei, Taiwan). The Kinect sensor incorporates infrared light and a video camera, which creates a 3D map of the area in front of it. This device provides full-body 3D motion capture.

The online exergaming-based physiotherapy programs focus on training in shoulder, hip, and knee ROM balance, weight-bearing, strength, weight shifting, and walking based on RF in machine learning to the features selection in patients with PIGD. The training tasks consist of 10 pieces of training (20 minutes per session, five sessions every week, for 8 weeks). Five exergaming programs were used for training, designed to incorporate an appropriate level of challenge to match the ability and fitness of patients with PD.

To confirm the status of individual training at home, the data will be sent back to the computer output report of the medical side after each training is completed. These data include the quantitative data of a joint ROM, the movement cycle change diagram, and the upper and low limb movements decomposed by each movement plane. The investigators also obtain the trajectory path mapping to understand whether the quality of individual actions is accurate, in place, and line with expected benchmarks.

Safety and Tolerability: If the patient can not complete half of the rehabilitation program, this/her data will be excluded from the analysis.

Exergame rehabilitation outcome assessments To evaluate the efficiency and the durability of the training effect. Outcomes were measured at five different periods including Month 0 (pretest) (clinical score, gait cycle, cognitive function, and fMRI), Month 2 (posttest) (clinical score, gait cycle, and fMRI), and Month 8 (follow-up) (clinical score, gait cycle, and cognitive function) and Year 2 and year 3 (follow-up) (clinical score, gait cycle, and cognitive function).

1. Functional Outcome Measure: Clinical scores and parameters of walking gait cycle The Functional Outcome measure includes the (1) UPDRS score, (2) Tinetti balance and gait score, (3) Berg Balance Scale, (4) Time-up to go test, and (5) parameters in the gait cycle including plantar pressure measurement, static and dynamic balance measures, COP trajectory measurements during gait initiation, and spatiotemporal and kinematic gait analysis in straightforward walking and turning through study completion, an average of three years.
2. Secondary outcome measures include Severity, frequency, and situations of falling and Physical (balance, mobility, freezing of gait, habitual physical activity) and psychological (fear of falling, affect) measures during the intervention and through study completion, an average of three years.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheng-Hsien Lu, MD; Phone Number: +886975056603; Email: chlu99@adm.cgmh.org.tw

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 83304
    • Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1． Clinical diagnosis of Parkinson's disease

Exclusion Criteria:

1. Moderate and severe dementia (Clinical Dementia Rating more than or equal to 2)
2. Advanced PD stage (Hoehn and Yahr staging equal or more than four)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online exergaming-based physiotherapy intervention group; The training tasks consist of a set of 10 pieces of training (20 min per session, five sessions every week, for 8 weeks)	Other: online exergaming-based physiotherapy programs; The online exergaming-based physiotherapy programs focus on training in shoulder, hip, and knee ROM balance, weight-bearing, strength, weight shifting, and walking based on RF in machine learning to the features selection in patients with PIGD. The training tasks consist of a set of 10 pieces of training (20 min per session, five sessions every week, for 8 weeks). Five exergaming programs were used for training, designed to incorporate an appropriate level of challenge to match the ability and fitness of patients with PD.
No Intervention: Online exergaming-based physiotherapy observation group; Observation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's Disease Rating Scale score assessment	The outcome measure is the Unified Parkinson's Disease Rating Scale score. The UPDRS scale consists of the following six segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, and 4) Complications of Therapy (in the past week) The four segments are made up of 42 items grouped into four subscales. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe)	Intervention and follow-up period through study completion, an average of 3 years
Tinetti balance and gait score assessment	The score consists of two parts, including the balance score (score=0-16) and gait score (score=0-12), and ranged from 0 to 28 points by summing the points obtained for each of the two tests.	Intervention and follow-up period through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall Risk assessment using Berg Balance Scale	The maximum obtainable Berg Balance Scale is 56 and there are four ranges of scores. Patients scoring range of 41-56, 21-40, and 0 -20 indicate low fall risk, medium fall risk, and high fall risk, respectively	intervention and follow-up period through study completion, an average of 3 years
Depression severity assessment	To obtain a patient-based measurement of depression, the Geriatric Depression Scale (GDS-30) was used. Depression severity was classified using the GDS-30 as follows: No depression (GDS 0-9), mild depression (GDS 10-19), and severe depression (GDS 20-30).	intervention and follow-up period through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: National Science and Technology Council

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson's disease; online exergaming-based physiotherapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Parkinsonian Disorders
• Other Study ID Numbers: 202201719B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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