An interventional study of online exergaming-based physiotherapy programs in Parkinsonism in Diseases Classified Elsewhere, sponsored by Chang Gung Memorial Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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.
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).
4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
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1． Clinical diagnosis of Parkinson's disease
Exclusion Criteria:
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
Observation only
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.
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)
Time frame: 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.
Time frame: Intervention and follow-up period through study completion, an average of 3 years
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
Time frame: 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).
Time frame: intervention and follow-up period through study completion, an average of 3 years
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr
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Chang Gung Memorial Hospital