Back to resultsGondola Mechanism of Action
Primary Purpose
Chronic Stroke, Cerebral Palsy, Parkinson's Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gondola AMPS
Sponsored by
About this trial
This is an interventional other trial for Chronic Stroke focused on measuring ambulation, sensory stimulation, mobility, neurological disorder
Eligibility Criteria
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.
Sites / Locations
- Abilities Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Real AMPS
Sham AMPS
Arm Description
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.
AMPS therapy applied to two non-specific points on both feet.
Outcomes
Primary Outcome Measures
Change in Soleus MVC
maximum voluntary contraction of the soleus muscle (measured by EMG)
Secondary Outcome Measures
Change in Tibialis anterior MVC
maximum voluntary contraction of tibialis anterior (measured by EMG)
Change in 10 meter walk test
self-selected pace to determine gait speed
Full Information
NCT ID
NCT05146648
First Posted
November 23, 2021
Last Updated
January 13, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05146648
Brief Title
Gondola Mechanism of Action
Official Title
Mechanism of Action for Effects From Automated Mechanical Peripheral Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
study withdrawn
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
January 12, 2023 (Actual)
Study Completion Date
January 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke, Cerebral Palsy, Parkinson's Disease
Keywords
ambulation, sensory stimulation, mobility, neurological disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real AMPS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham AMPS
Arm Type
Sham Comparator
Arm Description
AMPS therapy applied to two non-specific points on both feet.
Intervention Type
Device
Intervention Name(s)
Gondola AMPS
Other Intervention Name(s)
Automated Mechanical Peripheral Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Soleus MVC
Description
maximum voluntary contraction of the soleus muscle (measured by EMG)
Time Frame
pre and post-AMPS (baseline and 2 minutes)
Secondary Outcome Measure Information:
Title
Change in Tibialis anterior MVC
Description
maximum voluntary contraction of tibialis anterior (measured by EMG)
Time Frame
pre and post-AMPS (baseline and 2 minutes)
Title
Change in 10 meter walk test
Description
self-selected pace to determine gait speed
Time Frame
pre and post-AMPS (baseline and 2 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriela Rozanski
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Putrino, PT, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abilities Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not applicable to study aims
Learn more about this trial
Gondola Mechanism of Action
We'll reach out to this number within 24 hrs