Parkinson Disease
Conditions
Keywords
Automated Mechanical Peripheral Stimulation (AMPS), Gait Disorders
Brief summary
The purpose of this research study is to evaluate safety and effectiveness of the Automated Mechanical Peripheral Stimulation (AMPS) therapy given via the Gondola™ device to improving Gait and Gait Related Disorders in patients with Parkinson'disease (PD). Gondola® is a portable device that runs on batteries and is fitted on both patient's feet when the patient is lying down. The device has been designed for the stimulation of two areas of both feet (first toe and metatarsal) through mechanical impulses set up for pressure, duration and sequence (Automated Mechanical Peripheral Stimulation - AMPS); the therapy requires less than 2 minutes.
Detailed description
The proposed project, through a randomized multicentric, placebo controlled double-blind crossover trial aimed at evaluating the effectiveness of AMPS Gondola therapy versus Sham Gondola therapy in PD subjects. 132 in/outpatients with PD will be recruited. Subjects will be randomized in 2 groups, one starting with AMPS treatment, the other with placebo treatment. At the end of the first cycle of 6 stimulations over a 3 weeks' time (AMPS or Sham), all subjects will undergo a washout period of minimum 6 weeks, then will undergo another equivalent treatment cycle (Sham or AMPS); a follow up valuation 14 days after the end of each treatment cycle will be performed. This project is aimed at studying and documenting the effects of the AMPS treatment given to PD patients via the Gondola device in: 1. Improving gait, reducing bradykinesia, treating Freezing of Gait symptom; 2. Improving UPDRS II and III scores; 3. Improving balance. Another goal of the study is to document the safety of the Gondola device.
Interventions
DEVICEAMPS Gondola
Gondola is a portable device that runs on batteries and is fitted on both patient's feet when the patient is lying down. The device has been designed for the stimulation of two areas of both feet (first toe and metatarsal) through mechanical impulses set up for pressure, duration and sequence (Automated Mechanical Peripheral Stimulation - AMPS); the treatment requires less than 2 minutes.
DEVICESham Gondola
The Sham treatment consist in the stimulation of the same areas through mechanical impulses different for pressure since attached to the steel stick point is positioned a rigid plastic circle with a diameter (12mm); thanks to this the induced pressure ishence lower and the surface contact bigger
Sponsors
IRCCS San Raffaele Roma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Trained professionals, not directly involved in the research treatment and blind to patients group allocation, will perform clinical assessments. All subjects will undergo inpatient rehabilitation consisting of a treatment cycles using the Gondola device, once effective (AMPS treatment) and once placebo (Sham treatment).
Intervention model description
Subjects will be randomized in 2 groups, one starting with AMPS treatment, the other with placebo treatment. At the end of the first cycle of 6 stimulations over a 3 weeks' time (AMPS or Sham), all subject will undergo a washout period of minimum 6 weeks, then will undergo another equivalent treatment cycle (Sham or AMPS)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with clinically chronic and stable PD, confirmed according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBC); * Age 45 and older; * Hoehn & Yahr (H&Y) stage equal or higher than 2 in ON state; * Ability to walk autonomously or with minimal assistance for a 10 meters' distance in OFF state; * Antiparkinsonian treatment at a stable and optimized daily dosage during the 4 weeks prior to the study.
Exclusion criteria
* Any advanced, severe or unstable disease other than PD, which may interfere with the primary and secondary study outcome evaluations (autonomic dysfunction, diabetes, renal or hepatic failure, neoplasia, balance and gait problems of other origin). * Cognitive impairment with MoCA \< 18 * Any peripheral neurological or musculoskeletal conditions that may alter balance and/or gait. * Severe lower limb injuries in the previous 6 months. * History of neurosurgery or orthopedic surgery. * History of epilepsy. * Any drug treatment not intended to treat PD that may alter cognitive and/or motor performance. * History of depression or other psychiatric disorders. * Severe obesity defined as a BMI greater than 35.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between effective treatment phase versus placebo treatment phase in the change of gait speed from PRE-treatment cycle to POST treatment cycle | through study completion, an average of 16 weeks | Study success will be defined by an: improvement in gait speed of no less than 0,06 m/s as follows: H0: DT treatment phase - DT Sham phase \< 0.06m/s v.s. Ha: DT treatment phase - DT Sham phase ≥ 0.06m/s Where: DT = VPost6 - VPre VPost 6= gait speed after 6 treatment stimulations (at the end of the treatment cycle) Vpre = gait speed before the 1st treatment stimulation (at the beginning of the treatment cycle) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical evaluation in MDS-UPDRS | through study completion, an average of 16 weeks | Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease (MDS-UPDRS) range from 0 - less affect - to 272 - more affect |
| Change in clinical evaluation of step speed | through study completion, an average of 16 weeks | step length measured in meters per second |
| Change in time in walking | through study completion, an average of 16 weeks | time needed to perform the 10 meters walking test (seconds) |
| Change in clinical evaluation in FOG-Q | through study completion, an average of 16 weeks | FOG-Q is a questionnaire to assess Freezing of gait (FOG) and walking among patients with Parkinson's disase (range from 0 - less affect - to 24 -more affect) |
Countries
Italy
Outcome results
None listed