A pilot randomised controlled trial of a vestibular-stimulation, isometric exercise machine to manage symptoms of Parkinsonism
Monash UniversityDataset description
This study will test the efficacy of a novel therapeutic exercise machine at improving symptoms of Parkinson's disease and their neurological underpinnings in patients with Parkinson's Disease and Atypical Parkinsonism.The Reviver exercise machine simultaneously stimulates the vestibular system whilst inducing isometric exercise.
We hypothesise that a 12 week intervention on the Reviver will improve balance, mobility, and other motor symptoms of Parkinson's Disease.
Date Information
Identifiers
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12621000139875
Funding
Government body, Department of Industry Innovation and Science
Scientific enquiries
Dr Benjamin Sincair
Brief Summary
This study will test the efficacy of a novel therapeutic exercise machine at improving symptoms of Parkinson's disease and their neurological underpinnings in patients with Parkinson's Disease and Atypical Parkinsonism. The Reviver exercise machine simultaneously stimulates the vestibular system whilst inducing isometric exercise. We hypothesise that a 12 week intervention on the Reviver will improve balance, mobility, and other motor symptoms of Parkinson's Disease.
Key Inclusion Criteria
1. Diagnosis of Parkinson’s Disease or Atypical Parkinsonism 2. Stage 2, 3 or 4 on the Hoehn and Yahr scale 3. Ability to speak English 4. Willingness and ability to provide written informed consent 5. Willingness and ability to attend twice weekly intervention sessions for 12 weeks.
Key Exclusion Criteria
1. Significant dyskinesia 2. Significant motor fluctuations 3. Myasthenia Gravis, Charcot-Marie Tooth disease, Post-Polio Sundrome, Guillain–Barré syndrome, Fibromyalgia, herniated disk, osteoarthritis of the spine. 4. Diagnosis of dementia 5. Cognitive impairment that prevents patient from provided informed consent in the opinion of the recruiting study doctor. 6. Unable to undergo physical testing or ocular motor testing 7. Unstable or life-threatening disease or illness that could lead to dif .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 30
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Parkinson's disease , Atypical Parkinsonism
Condition code Physical Medicine / Rehabilitation , Neurological
Intervention
Intervention code Treatment: Devices , Rehabilitation
Patients randomised to the intervention will undertake two supervised sessions per week on the Reviver exercise machine (http://isodynamics.com.au), each with 15 minutes machine time, for a period of 12 weeks, taking place at the Alfred Hospital, Melbourne. The sessions will be one-on-one. The machine rotates the body at an angle of 5-30 degrees and subjects must tense their core and peripheral muscles in order to maintain an upright posture. A strap is placed around the patient’s waist to secur .... Read more
Comparison
Control group Active
Control subjects will continue their standard of care, with emphasis placed on maintaining their current levels of physical activity. Standard care is defined as maintaining their treatment schedule at baseline. This includes maintaining the same medication dosage and frequency, maintaining the same levels of physical activity , and maintaining any other treatment prescribed by their treating physician at time of enrollment. At the end of the study, control group participants will be offered the .... Read more
Outcomes
Outcome: The primary outcome will be the MDS-UPDRS rating scale for Parkinson’s Disease, a set of tests and questionnaires for measuring the severity of the disease. The scale has four sections: Part I: non-motor experiences of daily living Part II: motor experiences of daily living Part III: motor examination Part IV: motor complications Parts I, II and IV are questionnaires, delivered orally by the assessor and are rated on a scale of 0-4. Part III requires the patient to per .... Read more
Will the study consider sharing individual participant data?
Yes
Who can request access to individual participant data?
University partners undertaking multi-site studies.
Are there any conditions for requesting access to individual participant data?
-
What individual participant data might be shared?
Individual participant data not covered above
Group allocation and outcome measures (anonymised)
What types of analyses could be done with individual participant data?
Meta-analyses. Mega-analyses
Are there extra considerations when requesting access to individual participant data?
No
When can requests for individual data be made (start and end dates)?
From: From publication of trial, available for 5 years after publication
To: -