Chronic StrokeNCT05146648
Gondola Mechanism of Action
A study testing Gondola AMPS in people with Chronic Stroke and Cerebral Palsy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stroke, Cerebral Palsy, Parkinson's Disease
- What is being tested?
- Gondola AMPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2023to 12 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanism of Action for Effects From Automated Mechanical Peripheral Stimulation
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.
Read the detailed description
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
- Chronic Stroke, Cerebral Palsy, Parkinson's Disease
- Being tested
- Gondola AMPS
- Keywords
- ambulation, sensory stimulation, mobility, neurological disorder
- Medical subject headings
- Cerebral Palsy, Parkinson Disease, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gondola AMPSDevice
Also called Automated Mechanical Peripheral Stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Real AMPS | Active comparator | 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. Receives: Device: Gondola AMPS |
| Sham AMPS | Sham comparator | AMPS therapy applied to two non-specific points on both feet. Receives: Device: Gondola AMPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Soleus MVC
maximum voluntary contraction of the soleus muscle (measured by EMG)
Measured: pre and post-AMPS (baseline and 2 minutes)
Secondary outcomes (2)
Change in Tibialis anterior MVC
maximum voluntary contraction of tibialis anterior (measured by EMG)
Measured: pre and post-AMPS (baseline and 2 minutes)
Change in 10 meter walk test
self-selected pace to determine gait speed
Measured: pre and post-AMPS (baseline and 2 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start12 Jan 2023
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Why it stopped: study withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Putrino, Icahn School of Medicine at Mount Sinai
- Investigators
- Gabriela Rozanski, Study director, MOUNT SINAI HOSPITALDavid Putrino, PT, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146648
- Sponsor's protocol ID
- STUDY-21-00837
- Status last verified
- Jun 2022
- First submitted
- 23 Nov 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not applicable to study aims
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Action for Effects From Automated Mechanical Peripheral Stimulation
- ClinicalTrials.gov ID
- NCT05146648
- Acronym / sponsor ID
- STUDY-21-00837
- Conditions
- Chronic Stroke, Cerebral Palsy, Parkinson's Disease
- Keywords
- ambulation, sensory stimulation, mobility, neurological disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Real AMPS | Active comparator | Device: Gondola AMPSAMPS 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. |
| Sham AMPS | Sham comparator | Device: Gondola AMPSAMPS therapy applied to two non-specific points on both feet. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gondola AMPSAlso: Automated Mechanical Peripheral StimulationOne 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. | Device | Real AMPS, Sham AMPS |
Primary outcome
Change in Soleus MVC
Time frame: pre and post-AMPS (baseline and 2 minutes)
maximum voluntary contraction of the soleus muscle (measured by EMG)
2 secondary outcomes
Change in Tibialis anterior MVC
Time frame: pre and post-AMPS (baseline and 2 minutes)
Change in 10 meter walk test
Time frame: pre and post-AMPS (baseline and 2 minutes)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No. Not applicable to study aims
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Rozanski study director
MOUNT SINAI HOSPITAL
David Putrino, PT, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gondola AMPS in people with Chronic Stroke and Cerebral Palsy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Soleus MVC (time frame: pre and post-AMPS (baseline and 2 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.