Clinical trial NCT03843268: Study on the Device "Gondola" for Motor Rehabilitation in Parkinson's Disease
Official title: Multi-center, Double-blind, Cross-over Randomized Study on the Use of the Medical Device "Gondola" for Motor Rehabilitation in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Automated Mechanical Peripheral Stimulation (AMPS)
Gait Disorders
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 124
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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)
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference between effective treatment phase versus placebo treatment phase in the change of gait speed from PRE-treatment cycle to POST treatment cycle
timeFrame: through study completion, an average of 16 weeks
Secondary outcomes:
measure: Change in clinical evaluation in MDS-UPDRS
timeFrame: through study completion, an average of 16 weeks
measure: Change in clinical evaluation of step speed
timeFrame: through study completion, an average of 16 weeks
measure: Change in time in walking
timeFrame: through study completion, an average of 16 weeks
measure: Change in clinical evaluation in FOG-Q
timeFrame: through study completion, an average of 16 weeks
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: IRCCS San Raffaele
name: Fabrizio Stocchi, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Semprini R, Sale P, Foti C, Fini M, Franceschini M. Gait impairment in neurological disorders: a new technological approach. Funct Neurol. 2009 Oct-Dec;24(4):179-83.
citation: Nieuwboer A, Dom R, De Weerdt W, Desloovere K, Fieuws S, Broens-Kaucsik E. Abnormalities of the spatiotemporal characteristics of gait at the onset of freezing in Parkinson's disease. Mov Disord. 2001 Nov;16(6):1066-75. doi: 10.1002/mds.1206.
citation: Lo AC, Chang VC, Gianfrancesco MA, Friedman JH, Patterson TS, Benedicto DF. Reduction of freezing of gait in Parkinson's disease by repetitive robot-assisted treadmill training: a pilot study. J Neuroeng Rehabil. 2010 Oct 14;7:51. doi: 10.1186/1743-0003-7-51.