A pilot randomised controlled trial of a vestibular-stimulation, isometric exercise machine to manage symptoms of Parkinsonism

Intervention

Intervention code Rehabilitation , Treatment: Devices

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 .... 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 secure them to the machine and prevent falling. This machine design induces isometric exercise via a reflex response to falling, potentially recruiting involuntary muscular activation and deeply ingrained motor programs. The inclined nature of the machine’s motion periodically displaces cochlear fluid and presumably delivers a periodic stimulus to the vestibular nerves. In each session, patients will undertake 6 exercises on the machine designed by exercise physiologist, which target various aspects of strength and balance: 1) Squatting exercise for leg strength 2) Balancing forward exercise 3) Balancing backward exercise 4) Forward incline exercise, patient supported by straps, for back strength 5) Backward incline exercise, patient supported by straps, for abdominal strength 6) Forward incline exercise, patient supported by own arms, for whole body strength. The machine will be operated by a trained assistant. Adherence to the protocol will be recorded as the percentage of sessions attended. Patients will be asked beforehand whether they are willing and able to attend the required number of sessions over the three month period.
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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 .... 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 opportunity to undertake a shortened interventional regime on the Reviver machine of 6 x 15 minute sessions over 3 weeks.
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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 .... 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 perform simple motor tasks, which are observed and assessed by the assessor, and rated on a scale of 0-4.
Timepoint: baseline - week prior to commencement of intervention follow up - 12 weeks after intervention commencement
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