Gondola Mechanism of Action

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2023-01-12

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.

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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.

Conditions

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Chronic Stroke Cerebral Palsy Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

A blinded evaluator will collect all the demographic (age, gender, time since injury, injury type), clinical and functional data of the participants. The investigator performing transcranial magnetic stimulation assessments will also be blinded.

Study Groups

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Real AMPS

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.

Group Type ACTIVE_COMPARATOR

Gondola AMPS

Intervention Type DEVICE

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.

Sham AMPS

AMPS therapy applied to two non-specific points on both feet.

Group Type SHAM_COMPARATOR

Gondola AMPS

Intervention Type DEVICE

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.

Interventions

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Gondola AMPS

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.

Intervention Type DEVICE

Other Intervention Names

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Automated Mechanical Peripheral Stimulation

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes