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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
AMPS Gondola
Sham Gondola
Sponsored by
IRCCS San Raffaele Roma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Automated Mechanical Peripheral Stimulation (AMPS), Gait Disorders

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS San Raffaele

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AMPS Gondola

Sham Gondola

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in clinical evaluation in MDS-UPDRS
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
step length measured in meters per second
Change in time in walking
time needed to perform the 10 meters walking test (seconds)
Change in clinical evaluation in FOG-Q
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)

Full Information

First Posted
February 12, 2019
Last Updated
October 17, 2022
Sponsor
IRCCS San Raffaele Roma
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1. Study Identification

Unique Protocol Identification Number
NCT03843268
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele Roma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Automated Mechanical Peripheral Stimulation (AMPS), Gait Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Masking
ParticipantInvestigator
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).
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMPS Gondola
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Sham Gondola
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AMPS Gondola
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Gondola
Intervention Description
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 Outcome Measure Information:
Title
Difference between effective treatment phase versus placebo treatment phase in the change of gait speed from PRE-treatment cycle to POST treatment cycle
Description
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)
Time Frame
through study completion, an average of 16 weeks
Secondary Outcome Measure Information:
Title
Change in clinical evaluation in MDS-UPDRS
Description
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease (MDS-UPDRS) range from 0 - less affect - to 272 - more affect
Time Frame
through study completion, an average of 16 weeks
Title
Change in clinical evaluation of step speed
Description
step length measured in meters per second
Time Frame
through study completion, an average of 16 weeks
Title
Change in time in walking
Description
time needed to perform the 10 meters walking test (seconds)
Time Frame
through study completion, an average of 16 weeks
Title
Change in clinical evaluation in FOG-Q
Description
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)
Time Frame
through study completion, an average of 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrizio Stocchi, MD. PhD
Organizational Affiliation
IRCCS San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS San Raffaele
City
Roma
ZIP/Postal Code
00163
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20412722
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.
Results Reference
background
PubMed Identifier
11748737
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.
Results Reference
background
PubMed Identifier
20946640
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.
Results Reference
result

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

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