Gondola Mechanism of Action

Study Overview
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Brief Summary
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This study will investigate the clinical, functional and neurophysiological effects of automated mechanical peripheral stimulation (AMPS) via the Gondola device administered to patients with chronic stroke, cerebral palsy and Parkinson's Disease. Results will be collected using standardized outcome measures and a transcranial magnetic stimulation assessment protocol including electrical stimulation and electromyographic recording.

Detailed Description
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The working hypothesis for this pre-post intervention study is that one session of AMPS will increase voluntary motor drive of the plantar-flexors (soleus) muscle. The primary outcome measure will be maximum voluntary contraction (MVC) of the soleus (measured by electromyography, EMG); the secondary outcome will be the MVC of the antagonist muscle, the tibialis anterior. Data will be collected before the first session compared to directly after. The same measures in sham-stimulated and healthy volunteers will serve as controls.

Official Title
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Mechanism of Action for Effects From Automated Mechanical Peripheral Stimulation

Conditions
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Chronic Stroke, Cerebral Palsy, Parkinson's Disease

Intervention / Treatment
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* Device: Gondola AMPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 80; chronic stroke lesion >6 months after a cerebrovascular accident OR diagnosis of cerebral palsy OR Parkinson's Disease; presence of some degree of motor function in the ankle flexor (Soleus motor power >1); able to ambulate 10 meters without physical assistance. Exclusion Criteria: medically unstable condition; presence of other concurrent neurological illness; cognitive impairment (Montreal Cognitive Assessment score <23); presence of any potential TMS risk factor: damaged skin at the site of stimulation; presence of an electrically, magnetically or mechanically activated implant, an intracerebral vascular clip, or any other electrically sensitive support system; family history of medication-resistant epilepsy; past history of seizures or unexplained spells of loss of consciousness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Twenty adult individuals in the chronic phase of stroke, 20 people with cerebral palsy, 20 with Parkinson's Disease (intermediate stage) and 20 healthy volunteers will be randomized to receive sham or real AMPS intervention.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real AMPS<br>AMPS therapy consists of mechanical stimulations applied to two specific points on both feet: the tip of the big toe (hallux) and the first metatarsal joint. | Device: Gondola AMPS<br>* One treatment session lasts about two minutes and consists of the application of a mechanical pressure pulses on each of the points, one after the other, for a set duration (a few seconds), which is repeated several times in sequence.<br>* Other names: Automated Mechanical Peripheral Stimulation;|
| Sham Comparator: Sham AMPS<br>AMPS therapy applied to two non-specific points on both feet. | Device: Gondola AMPS<br>* One treatment session lasts about two minutes and consists of the application of a mechanical pressure pulses on each of the points, one after the other, for a set duration (a few seconds), which is repeated several times in sequence.<br>* Other names: Automated Mechanical Peripheral Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Soleus MVC | maximum voluntary contraction of the soleus muscle (measured by EMG) | pre and post-AMPS (baseline and 2 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tibialis anterior MVC | maximum voluntary contraction of tibialis anterior (measured by EMG) | pre and post-AMPS (baseline and 2 minutes) | 
| Change in 10 meter walk test | self-selected pace to determine gait speed | pre and post-AMPS (baseline and 2 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ambulation, sensory stimulation, mobility, neurological disorder