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Parkinsonism in Diseases Classified ElsewhereNCT06317792

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

A study testing online exergaming-based physiotherapy programs in people with Parkinsonism in Diseases Classified Elsewhere, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 90 yearsHealthy volunteers can take part
What is being tested?
online exergaming-based physiotherapy programs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTaiwan
Study dates
1 Apr 2024to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1. Clinical diagnosis of Parkinson's disease

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Cheng-Hsien Lu, MD contact

+886975056603

chlu99@adm.cgmh.org.tw

Taiwan1 site
  • Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine

    Kaohsiung City, 83304

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.
Being tested
online exergaming-based physiotherapy programs
Keywords
online exergaming-based physiotherapy, Parkinson's disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • online exergaming-based physiotherapy programsOther

    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.

Study groups in NCT06317792
Study groupRoleWhat they receive
Online exergaming-based physiotherapy intervention groupExperimentalThe training tasks consist of a set of 10 pieces of training (20 min per session, five sessions every week, for 8 weeks)
Receives: Other: online exergaming-based physiotherapy programs
Online exergaming-based physiotherapy observation groupNo interventionObservation only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Intervention and follow-up period through study completion, an average of 3 years

  2. 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.

    Measured: Intervention and follow-up period through study completion, an average of 3 years

Secondary outcomes (2)
  1. 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

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

  2. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be divided into two groups in a randomized controlled study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06317792
Sponsor's protocol ID
202201719B0
Status last verified
Mar 2024
First submitted
21 Feb 2024
Last updated
19 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing online exergaming-based physiotherapy programs in people with Parkinsonism in Diseases Classified Elsewhere, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cheng-Hsien Lu, MD (+886975056603, chlu99@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unified Parkinson's Disease Rating Scale score assessment (time frame: Intervention and follow-up period through study completion, an average of 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.

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