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

NCT06317792 | Not Yet Recruiting DMC

• 1 other identifier: 202201719B0
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinsonism in Diseases Classified Elsewhere

Keywords

online exergaming-based physiotherapy; Parkinson's disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Fall Risk assessment using Berg Balance Scale

  intervention and follow-up period through study completion, an average of 3 years

• Depression severity assessment

  intervention and follow-up period through study completion, an average of 3 years

Study Arms (2)

Online exergaming-based physiotherapy intervention group

EXPERIMENTAL

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

Online exergaming-based physiotherapy observation group

NO INTERVENTION

Observation only

Interventions

online exergaming-based physiotherapy programs OTHER

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.

Online exergaming-based physiotherapy intervention group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ． Clinical diagnosis of Parkinson's disease

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council: collaborator

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine

Kaohsiung City, 83304, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Cheng-Hsien Lu, MD

CONTACT

+886975056603; chlu99@adm.cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of neurology

Model Details: Participants will be divided into two groups in a randomized controlled study

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 19, 2024
• Study Start: April 1, 2024
• Primary Completion: March 31, 2026
• Study Completion: June 30, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TW (1)