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Completed

NCT Number: NCT03843268

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mobility Limitation Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele

Roma, 00163, Italy

About this study

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:

  • Improving gait, reducing bradykinesia, treating Freezing of Gait symptom;
  • Improving UPDRS II and III scores;
  • Improving balance. Another goal of the study is to document the safety of the Gondola device.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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

    Time frame: 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 outcomes

  1. Change in clinical evaluation in MDS-UPDRS

    Time frame: 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

  2. Change in clinical evaluation of step speed

    Time frame: through study completion, an average of 16 weeks

    step length measured in meters per second

  3. Change in time in walking

    Time frame: through study completion, an average of 16 weeks

    time needed to perform the 10 meters walking test (seconds)

  4. Change in clinical evaluation in FOG-Q

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Official study 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

Acronym: GondoPark V2

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 18, 2019
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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