Study on the Device "Gondola" for Motor Rehabilitation in Parkinson's Disease

NCT03843268 | Completed

• 1 other identifier: RP 13/17
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Automated Mechanical Peripheral Stimulation (AMPS); Gait Disorders

Outcome Measures

Primary Outcomes (1)

• Difference between effective treatment phase versus placebo treatment phase in the change of gait speed from PRE-treatment cycle to POST treatment cycle

  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)

  through study completion, an average of 16 weeks

Secondary Outcomes (4)

• Change in clinical evaluation in MDS-UPDRS

  through study completion, an average of 16 weeks

• Change in clinical evaluation of step speed

  through study completion, an average of 16 weeks

• Change in time in walking

  through study completion, an average of 16 weeks

• Change in clinical evaluation in FOG-Q

  through study completion, an average of 16 weeks

Study Arms (2)

AMPS Gondola

ACTIVE COMPARATOR

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)

Device: AMPS Gondola; Device: Sham Gondola

Sham Gondola

PLACEBO COMPARATOR

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.

Device: AMPS Gondola; Device: Sham Gondola

Interventions

AMPS Gondola DEVICE

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.

AMPS Gondola; Sham Gondola

Sham Gondola DEVICE

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

AMPS Gondola; Sham Gondola

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele

Roma, 00163, Italy

Location

Related Publications (4)

• 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.

  PMID: 20412722 BACKGROUND

• 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.

  PMID: 11748737 BACKGROUND

• 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.

  PMID: 20946640 RESULT

• De Pandis MF, Tomino C, Proietti S, Rotondo R, Gaglione M, Casali M, Corbo M, di Biase L, Galli M, Goffredo M, Stocchi F. Mechanical peripheral stimulation for the treatment of gait disorders in patients with Parkinson's disease: a multi-centre, double-blind, crossover randomized controlled trial. J Neuroeng Rehabil. 2025 Apr 8;22(1):77. doi: 10.1186/s12984-025-01574-3.

  PMID: 40200338 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabrizio Stocchi, MD. PhD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 18, 2019
• Study Start: December 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: April 10, 2024

Record last verified: 2022-10

Locations

IT (1)