Trials Sponsors Conditions Drugs Pricing

Conditions

Cerebral Palsy Chronic Stroke Parkinson's Disease

Keywords

ambulationsensory stimulationmobilityneurological disorder

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

Change in Tibialis anterior MVC
pre and post-AMPS (baseline and 2 minutes)
Change in 10 meter walk test
pre and post-AMPS (baseline and 2 minutes)

Study Arms (2)

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.

Device: Gondola AMPS

Sham AMPS

SHAM COMPARATOR

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

Device: Gondola AMPS

Interventions

Gondola AMPSDevice

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.

Also known as: Automated Mechanical Peripheral Stimulation

Real AMPSSham AMPS

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

age 18 to 80;
chronic stroke lesion \>6 months after a cerebrovascular accident OR diagnosis of cerebral palsy OR Parkinson's Disease;

Sponsors & Collaborators

Icahn School of Medicine at Mount Sinai
Otherlead

Study Sites (1)

Abilities Research Center

New York, New York, 10029, United States

MeSH Terms

Conditions

Cerebral PalsyParkinson DiseaseNervous System Diseases

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

Gabriela Rozanski
MOUNT SINAI HOSPITAL
STUDY DIRECTOR
David Putrino, PT, PhD
Icahn School of Medicine at Mount Sinai
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: 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.
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director of Rehabilitation Innovation for the Mount Sinai Health System; Associate Professor, Rehabilitation Medicine

Study Record Dates

First Submitted

November 23, 2021

Study Stopped

Gondola Mechanism of Action

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Real AMPS

Sham AMPS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Real AMPS

Sham AMPS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations