Cerebral Palsy, Chronic Stroke, Parkinson's Disease
Conditions
Keywords
ambulation, sensory stimulation, mobility, neurological disorder
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.
Interventions
DEVICEGondola 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.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Soleus MVC | pre and post-AMPS (baseline and 2 minutes) | maximum voluntary contraction of the soleus muscle (measured by EMG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tibialis anterior MVC | pre and post-AMPS (baseline and 2 minutes) | maximum voluntary contraction of tibialis anterior (measured by EMG) |
| Change in 10 meter walk test | pre and post-AMPS (baseline and 2 minutes) | self-selected pace to determine gait speed |
Countries
United States
Outcome results
None listed