Clinical trial NCT05046236: Interactive POWER Rehabilitation System on Rehabilitation Training for Patients With Parkinson's Disease
Official title: Developing Visual Feedback-aided Power Rehabilitation System and Exploring Its' Applications on Rehabilitation Training for Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Interactive POWER rehabilitation
Applications
Data analysis
Laser sensors
Parkinson's disease
Machine learning
Physical function
Exercise intervention
Activities of daily living
Functional training
Quality of life
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Far Eastern Memorial Hospital
First posted: 2021-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the previous studies, progressive resistance training (PRT) has significantly improved the muscle strength and disease severity of Parkinson's disease. However, there is currently no consensus on the impact of PRT on physical function such as balance and walking ability for Parkinson's patients. Therefore, this study focuses on developing a visual feedback system added to the original POWER rehabilitation system, and to investigate whether the training through this "interactive POWER rehabilitation system" can produce the clinical benefits, as well as improving the daily life of patients with Parkinson's disease.

Detailed description: Parkinson's disease (PD) is a progressive neurodegenerative disease of the central nervous system with complex etiology. This disease is related to the consumption of dopamine in the substantia nigra of the brain, and it is currently believed that the main factors of consumption of dopamine are (1) heredity (2) aging (3) environment.

At present, there are many rehabilitation treatments available for patients with Parkinson's disease, such as: progressive resistance training, yoga, Tai Chi, dancing, cognitive training, balance training, gait training, bicycle, and treadmill training, etc. During the recent years, the POWER rehabilitation system from Japan (Procedure Outcome Worthwhile for Elderly Rehabilitation, referred to as POWER rehabilitation) including six types of equipment for strengthening different body parts has been applied to frail elderly or neurological patients gradually.

Parkinson's patients are often considered to have major difficulties in responding to motion disturbances (inability to respond appropriately), leading to learning, insufficient attention and motivation problems. Therefore, maintenance of motivation and feedback on performance are key factors that affect the participation of exercises in patients with Parkinson's disease.

The application of virtual reality in patients with PD is becoming more and more effective. An integrated rehabilitation system can not only enable the clinicians to check the rehabilitation status during the treatment, but also provide feedbacks to the patient through the interactive visual feedback screen. For Parkinson's patients, providing visual feedback through virtual reality intervention may be of particular clinical value.

In the first phase of this study, a virtual reality-like visual feedback system will be developed and combined with the original "POWER rehabilitation system" to form the so-called "Interactive POWER Rehabilitation System", and then system verification will be carried out. In the second phase of this study, this newly developed system will be applied to the rehabilitation training for patients with Parkinson's disease, and to explore whether the combination of POWER rehabilitation with visual feedback can produce the clinical benefits, as well as improving the daily life of patients with PD. Patients will be randomly assigned into three groups: interactive POWER, functional training, and control group. Single blind data collection will be used. Patients will be evaluated at baseline and post 12-week interventions. Outcome measures will include mini-BESTest, Unified Parkinson's disease rating scale, muscle strength of upper and lower extremities, timed up and go, 6-minute walking test, gait, and Parkinson's disease questionnaire PDQ-39.

It is expected that the "Interactive POWER Rehabilitation System" can promote the learning ability of patients with Parkinson's disease by adding visual feedbacks and enhance the treatment effects. It also offer rehabilitation clinicians more treatment options, lower the administrative costs of supporting staffs, reduce commuting costs for the patients, and elevate patients' desire to comply with the treatment program.

Eligibility criteria: Inclusion Criteria of phase I study

1. Healthy Volunteer (can walk 15 meters independently or with assistive devices).
2. Aged 20-70 years old.
3. Mini-mental state examination (MMSE) points above 24.
4. Not familiar with POWER rehabilitation machines before this study.
5. Able to understand POWER rehabilitation training and test items.
6. Able to use smart devices and be willing to cooperate with pre-acceptance instructions.
7. Able to communicate in Mandarin or Taiwanese, and be able to clearly express uncomfortable feelings.
8. Willing to participate in this study after explanations, and sign the subject's informed consent.

Inclusion Criteria of phase II study

1. Diagnosed as Idiopathic Parkinsonism by Neurologist
2. PD stages of I-III according to the modified Hoehn and Yahr Scale
3. Aged 45-85 years old
4. Mini-mental state testing (MMSE) 24 points or more
5. Stable medication regimen for at least 2 weeks before the trial
6. Can walk 15 meters independently or with devices
7. Able to understand treatment and assessment
8. Able to understand and be willing to agree to the informed consent form

Exclusion Criteria of phase I study

1. People who do not use smart devices and are unwilling to cooperate with the pre-acceptance instructions.
2. Have severe hearing or vision impairments.
3. Pregnant or breast-feeding.
4. Any chronic condition that may cause safety concerns.
5. Having any diseases which are contraindications for exercise participation.
6. Muscle strength is affected by taking drugs.
7. Have been to the gym 6 months before participating in the study (e.g. aerobic exercise, resistance training).
8. Severe orthopedic diseases (unhealed fractures, severe joint destructions, and joints with fixed deformities, etc.).
9. Severe or unstable neurological or cardiopulmonary diseases (severe cases of stroke and myocardial infarction in the acute phase, arrhythmia or uncontrolled blood pressure, etc.).
10. Diagnosed with any mental illness (e.g., depression, psychosis or other mental illnesses)
11. Unwilling to participate in this research.

Exclusion Criteria of phase II study

1. Rheumatism
2. Cardiovascular diseases or respiratory diseases (e.g., angina pectoris, pulmonary embolism, etc.)
3. Severe or unstable neurological or orthopedic diseases.
4. Severe hearing or vision impairments
5. Diagnosed with any mental illness(e.g., depression, psychosis or other mental illnesses)
6. A history of epilepsy.
7. Pregnancy or pregnancy
8. Any uncontrolled disease.

Primary outcomes:
measure: Change from Baseline Unified Parkinson's Disease Rating Scale at 12 weeks
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change from Baseline he Parkinson's Disease Questionnaire (PDQ-39) at 12 weeks
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change from Baseline the Mini-Mental State Exam (MMSE) at 12 weeks
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change from Baseline the Timed Up and Go test (TUG) at 12 weeks
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change from Baseline Mini-BESTest at 12 weeks
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change from Baseline six minute walk test (6MWT) at 12 weeks
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change from Baseline muscle strength of upper limbs at 12 weeks
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change from Baseline muscle strength of lower limbs at 12 weeks
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change from Baseline gait Speed at 12 weeks
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change from Baseline cadence at 12 weeks
timeFrame: Baseline and post-intervention at 12 weeks
measure: Change from Baseline stride length at 12 weeks
timeFrame: Baseline and post-intervention at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern memorial hospital
city: New Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Si-Huei Lee, PhD
role: STUDY_CHAIR
References: