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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000139875
Enrollment
30
Registered
2021-02-11
Start date
2019-09-10
Completion date
2021-10-13
Last updated
2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 secu

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.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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 difficulty complying with the protocol 8. Medical condition that contraindicates physical activity 9. Severe visual or auditory impairment 10. History of chronic alcohol abuse within the past 5 years 11. Unable to attend the follow-up assessments 12. Diagnosis of neurological disorder affecting balance 13. Diagnosis of muscular disorder affecting balance

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026