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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000291886
Enrollment
14
Registered
2021-03-16
Start date
2021-03-29
Completion date
2021-06-01
Last updated
2021-03-22

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 sub-study will test the effect of a novel therapeutic exercise machine on MRI-derived measures of brain health 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 increase brain volumes, decrease number of enlarged perivascular spaces and decrease brain iron deposition.

Interventions

ACTRN12621000139875 describes a 12 week intervention using a physical exercise assistance device for patients with Parkinson's disease. The primary outcome measure was part 3 of the UPDRS ratings scale. The current application will include new patients enrolling in that trial and add MRI scanning as an additional outcome measure. After approval of this registration, all patients recruited in the main trial will be offered the option to undergo MRI scanning, which will involve T1, T2, diffusion a

ACTRN12621000139875 describes a 12 week intervention using a physical exercise assistance device for patients with Parkinson's disease. The primary outcome measure was part 3 of the UPDRS ratings scale. The current application will include new patients enrolling in that trial and add MRI scanning as an additional outcome measure. After approval of this registration, all patients recruited in the main trial will be offered the option to undergo MRI scanning, which will involve T1, T2, diffusion and functional MRI scans at baseline and follow up, in addition to the other outcome measurements for the main trial described in step 4. Imaging sessions will take place the week prior to the intervention commencement and 13 weeks after intervention commencement. They will last 30 minutes. The will be conducted by a radiologist at Alfred Hospital.

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 14. Unable to undergo MRI scans

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026