Parkinson DiseaseNCT05046236
Interactive POWER Rehabilitation System on Rehabilitation Training for Patients With Parkinson's Disease
A study testing Interactive POWER rehabilitation and Conventical physical training in people with Parkinson Disease, run by Taipei Veterans General Hospital, Taiwan at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Interactive POWER rehabilitation and Conventical physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Oct 2021to 30 Aug 2022
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteer (can walk 15 meters independently or with assistive devices).
- Aged 20-70 years old.
- Mini-mental state examination (MMSE) points above 24.
- Not familiar with POWER rehabilitation machines before this study.
- Able to understand POWER rehabilitation training and test items.
- Able to use smart devices and be willing to cooperate with pre-acceptance instructions.
Show all 16Show fewer
- Able to communicate in Mandarin or Taiwanese, and be able to clearly express uncomfortable feelings.
- Willing to participate in this study after explanations, and sign the subject's informed consent.
- Diagnosed as Idiopathic Parkinsonism by Neurologist
- PD stages of I-III according to the modified Hoehn and Yahr Scale
- Aged 45-85 years old
- Mini-mental state testing (MMSE) 24 points or more
- Stable medication regimen for at least 2 weeks before the trial
- Can walk 15 meters independently or with devices
- Able to understand treatment and assessment
- Able to understand and be willing to agree to the informed consent form
Who cannot join
- People who do not use smart devices and are unwilling to cooperate with the pre-acceptance instructions.
- Have severe hearing or vision impairments.
- Pregnant or breast-feeding.
- Any chronic condition that may cause safety concerns.
- Having any diseases which are contraindications for exercise participation.
- Muscle strength is affected by taking drugs.
Show all 19Show fewer
- Have been to the gym 6 months before participating in the study (e.g. aerobic exercise, resistance training).
- Severe orthopedic diseases (unhealed fractures, severe joint destructions, and joints with fixed deformities, etc.).
- Severe or unstable neurological or cardiopulmonary diseases (severe cases of stroke and myocardial infarction in the acute phase, arrhythmia or uncontrolled blood pressure, etc.).
- Diagnosed with any mental illness (e.g., depression, psychosis or other mental illnesses)
- Unwilling to participate in this research.
- Rheumatism
- Cardiovascular diseases or respiratory diseases (e.g., angina pectoris, pulmonary embolism, etc.)
- Severe or unstable neurological or orthopedic diseases.
- Severe hearing or vision impairments
- Diagnosed with any mental illness(e.g., depression, psychosis or other mental illnesses)
- A history of epilepsy.
- Pregnancy or pregnancy
- Any uncontrolled disease.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Far Eastern memorial hospital
New Taipei City, 220
Chao-Chun Huang, Bachelor, 866-2-77281501
- Recruiting
Taipei Veterans General Hospital
New Taipei City
Si-Huei Lee, PhD, 886-938591985
About this study
Official title: Developing Visual Feedback-aided Power Rehabilitation System and Exploring Its' Applications on Rehabilitation Training for Patients With Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Interactive POWER rehabilitation, Conventical physical training
- 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
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive POWER rehabilitationOther
Interactive POWER rehabilitation training for twice a week, total 12 weeks, that consisted of 6 types of equipment for strength training.
Conventical physical trainingOther
Conventional physical training models in current clinical use for twice a week, total 12 weeks, that consisted of strength training, balance training, stretching, gait training, and etc.
| Study group | Role | What they receive |
|---|---|---|
| Interactive POWER rehabilitation | Experimental | Participants in this group would be treated with POWER for twice a week, total 12 weeks. Receives: Other: Interactive POWER rehabilitation |
| Conventical physical training Group | Active comparator | Participants in this group would be treated with traditional exercise rehabilitation for twice a week, total 12 weeks. Receives: Other: Conventical physical training |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Unified Parkinson's Disease Rating Scale at 12 weeks
A comprehensive assessment of both motor and non-motor symptoms associated with Parkinson's. The Unified Parkinson's Disease Rating Scale is made up of 42 items. These items are divided into six sections which are separately "evaluation of mentation, behavior, and mood", "self-evaluation of the activities of daily life", "clinician-scored monitored motor evaluation", "complications of therapy", "Hoehn and Yahr staging of severity of Parkinson's disease" and "Schwab and England ADL scale".The evaluation score for the first item to the 39th item is 0 to 4 points. The evaluation score for the 40th to the 42th item is 0 to 1 points. The higher score meand the worse condition. The sum of all the items'score is the score of the scale. Higher Rating Scales'scores indicate severe symptoms.
Measured: Baseline and post-intervention at 12 weeks
Change from Baseline he Parkinson's Disease Questionnaire (PDQ-39) at 12 weeks
The 39-point PDQ provides scores for each of the 8 scales: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communications and bodily discomfort. It is used to assess the overall health-related quality of life profile of the individual questioned.
Measured: Baseline and post-intervention at 12 weeks
Change from Baseline the Mini-Mental State Exam (MMSE) at 12 weeks
A widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.
Measured: Baseline and post-intervention at 12 weeks
Change from Baseline the Timed Up and Go test (TUG) at 12 weeks
A simple test used to assess a person's mobility and requires both static and dynamic balance.
It measures the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Measured: Baseline and post-intervention at 12 weeks
Change from Baseline Mini-BESTest at 12 weeks
The scale includes four items: (1) anticipatory balance, (2) reactive posture control, (3) sensory orientation, and (4) dynamic gait, A total of 14 measurement items, 2 points for each question, a total of 28 points.
Measured: Baseline and post-intervention at 12 weeks
Change from Baseline six minute walk test (6MWT) at 12 weeks
Walk for six minutes at the subject's preferred speed and assistive devices. You can stop at any time in the middle. After the end, the walking distance will be recorded, and changes in heartbeat, blood pressure, blood oxygen saturation, dyspnea and fatigue will be monitored. It will also end at the end then evaluate the walking distance.
Measured: Baseline and post-intervention at 12 weeks
Change from Baseline muscle strength of upper limbs at 12 weeks
Use a hand-grip dynamometer to test the grip strength. Both hands need to be measured twice individually, with a rest time of at least 30 seconds between the two.
Measured: Baseline and post-intervention at 12 weeks
Change from Baseline muscle strength of lower limbs at 12 weeks
Use Micro FET3 instrument to measure knee joint extension and flexion; hip joint abduction and flexion muscle strength. Each muscle group needs to be tested twice, with a 30-second rest between the two, and two recordings Take the maximum value afterwards.
Measured: Baseline and post-intervention at 12 weeks
Change from Baseline gait Speed at 12 weeks
The subjects were asked to wear an inertial sensor "Physilog®" (Gait Up, Lausanne, Switzerland) on each foot during a 10-meter walking test to collect gait data. Spatiotemporal gait parameters were calculated with the Gait Analysis Software provided by Gait Up, including the following lists. Stopwatch will also be employed by the operator to measure the walking time simultaneously.
- Speed (m/s): Mean walking stride velocity of forward walking
Measured: Baseline and post-intervention at 12 weeks
Change from Baseline cadence at 12 weeks
The subjects were asked to wear an inertial sensor "Physilog®" (Gait Up, Lausanne, Switzerland) on each foot during a 10-meter walking test to collect gait data. Spatiotemporal gait parameters were calculated with the Gait Analysis Software provided by Gait Up.
- Cadence (step/minute): Number of steps in a minute
Measured: Baseline and post-intervention at 12 weeks
Change from Baseline stride length at 12 weeks
The subjects were asked to wear an inertial sensor "Physilog®" (Gait Up, Lausanne, Switzerland) on each foot during a 10-meter walking test to collect gait data. Spatiotemporal gait parameters were calculated with the Gait Analysis Software provided by Gait Up.
- Stride length (m): Distance between two consecutive footprints on the ground
Measured: Baseline and post-intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Oct 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Far Eastern Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Si-Huei Lee, PhD, Study chair, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046236
- Sponsor's protocol ID
- 2021-05-004A
- Status last verified
- Apr 2022
- First submitted
- 29 Jul 2021
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Visual Feedback-aided Power Rehabilitation System and Exploring Its' Applications on Rehabilitation Training for Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05046236
- Acronym / sponsor ID
- 2021-05-004A
- Conditions
- Parkinson Disease
- Keywords
- Interactive POWER rehabilitation, Applications, Data analysis, Laser sensors, Parkinson's disease, Machine learning, Physical function, Exercise intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Far Eastern Memorial Hospital
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interactive POWER rehabilitation | Experimental | Other: Interactive POWER rehabilitationParticipants in this group would be treated with POWER for twice a week, total 12 weeks. |
| Conventical physical training Group | Active comparator | Other: Conventical physical trainingParticipants in this group would be treated with traditional exercise rehabilitation for twice a week, total 12 weeks. |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Healthy Volunteer (can walk 15 meters independently or with assistive devices).
- Aged 20-70 years old.
- Mini-mental state examination (MMSE) points above 24.
- Not familiar with POWER rehabilitation machines before this study.
- Able to understand POWER rehabilitation training and test items.
Key exclusion criteria (19 listed)
- People who do not use smart devices and are unwilling to cooperate with the pre-acceptance instructions.
- Have severe hearing or vision impairments.
- Pregnant or breast-feeding.
- Any chronic condition that may cause safety concerns.
- Having any diseases which are contraindications for exercise participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive POWER rehabilitationInteractive POWER rehabilitation training for twice a week, total 12 weeks, that consisted of 6 types of equipment for strength training. | Other | Interactive POWER rehabilitation |
| Conventical physical trainingConventional physical training models in current clinical use for twice a week, total 12 weeks, that consisted of strength training, balance training, stretching, gait training, and etc. | Other | Conventical physical training Group |
Primary outcome
Change from Baseline Unified Parkinson's Disease Rating Scale at 12 weeks
Time frame: Baseline and post-intervention at 12 weeks
A comprehensive assessment of both motor and non-motor symptoms associated with Parkinson's. The Unified Parkinson's Disease Rating Scale is made up of 42 items. These items are divided into six sections which are separately "evaluation of mentation, behavior, and mood", "self-evaluation of the activities of daily life", "clinician-scored monitored motor evaluation", "complications of therapy", "Hoehn and Yahr staging of severity of Parkinson's disease" and "Schwab and England ADL scale".The evaluation score for the first item to the 39th item is 0 to 4 points. The evaluation score for the 40th to the 42th item is 0 to 1 points. The higher score meand the worse condition. The sum of all the items'score is the score of the scale. Higher Rating Scales'scores indicate severe symptoms.
Change from Baseline he Parkinson's Disease Questionnaire (PDQ-39) at 12 weeks
Time frame: Baseline and post-intervention at 12 weeks
The 39-point PDQ provides scores for each of the 8 scales: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communications and bodily discomfort. It is used to assess the overall health-related quality of life profile of the individual questioned.
Change from Baseline the Mini-Mental State Exam (MMSE) at 12 weeks
Time frame: Baseline and post-intervention at 12 weeks
A widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.
Change from Baseline the Timed Up and Go test (TUG) at 12 weeks
Time frame: Baseline and post-intervention at 12 weeks
A simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Change from Baseline Mini-BESTest at 12 weeks
Time frame: Baseline and post-intervention at 12 weeks
The scale includes four items: (1) anticipatory balance, (2) reactive posture control, (3) sensory orientation, and (4) dynamic gait, A total of 14 measurement items, 2 points for each question, a total of 28 points.
Change from Baseline six minute walk test (6MWT) at 12 weeks
Time frame: Baseline and post-intervention at 12 weeks
Walk for six minutes at the subject's preferred speed and assistive devices. You can stop at any time in the middle. After the end, the walking distance will be recorded, and changes in heartbeat, blood pressure, blood oxygen saturation, dyspnea and fatigue will be monitored. It will also end at the end then evaluate the walking distance.
Change from Baseline muscle strength of upper limbs at 12 weeks
Time frame: Baseline and post-intervention at 12 weeks
Use a hand-grip dynamometer to test the grip strength. Both hands need to be measured twice individually, with a rest time of at least 30 seconds between the two.
Change from Baseline muscle strength of lower limbs at 12 weeks
Time frame: Baseline and post-intervention at 12 weeks
Use Micro FET3 instrument to measure knee joint extension and flexion; hip joint abduction and flexion muscle strength. Each muscle group needs to be tested twice, with a 30-second rest between the two, and two recordings Take the maximum value afterwards.
Change from Baseline gait Speed at 12 weeks
Time frame: Baseline and post-intervention at 12 weeks
The subjects were asked to wear an inertial sensor "Physilog®" (Gait Up, Lausanne, Switzerland) on each foot during a 10-meter walking test to collect gait data. Spatiotemporal gait parameters were calculated with the Gait Analysis Software provided by Gait Up, including the following lists. Stopwatch will also be employed by the operator to measure the walking time simultaneously. - Speed (m/s): Mean walking stride velocity of forward walking
Change from Baseline cadence at 12 weeks
Time frame: Baseline and post-intervention at 12 weeks
The subjects were asked to wear an inertial sensor "Physilog®" (Gait Up, Lausanne, Switzerland) on each foot during a 10-meter walking test to collect gait data. Spatiotemporal gait parameters were calculated with the Gait Analysis Software provided by Gait Up. - Cadence (step/minute): Number of steps in a minute
Change from Baseline stride length at 12 weeks
Time frame: Baseline and post-intervention at 12 weeks
The subjects were asked to wear an inertial sensor "Physilog®" (Gait Up, Lausanne, Switzerland) on each foot during a 10-meter walking test to collect gait data. Spatiotemporal gait parameters were calculated with the Gait Analysis Software provided by Gait Up. - Stride length (m): Distance between two consecutive footprints on the ground
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Si-Huei Lee, PhD study chair
Taipei Veterans General Hospital, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive POWER rehabilitation and Conventical physical training in people with Parkinson Disease, run by Taipei Veterans General Hospital, Taiwan at 2 sites 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 16 inclusion and 19 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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Szu-Min Fu, Student (886-982202892, szuminfu.be09@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Unified Parkinson's Disease Rating Scale at 12 weeks (time frame: Baseline and post-intervention at 12 weeks). The study lists 11 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 4 Apr 2022.