Status:
COMPLETED
Study on the Device "Gondola" for Motor Rehabilitation in Parkinson's Disease
Lead Sponsor:
IRCCS San Raffaele Roma
Conditions:
Parkinson Disease
Eligibility:
All Genders
45+ years
Phase:
NA
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 Re...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT03843268
Start Date
December 1 2017
End Date
September 30 2019
Last Update
April 10 2024
Active Locations (1)
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1
IRCCS San Raffaele
Roma, Italy, 00163