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

Parkinson Disease Clinical Trial

— GondoPark V2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843268
• Other study ID #: RP 13/17
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2022
• Source: IRCCS San Raffaele Roma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• AMPS Gondola
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
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

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Roma

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele Roma

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	through study completion, an average of 16 weeks
Secondary	Change in clinical evaluation of step speed	step length measured in meters per second	through study completion, an average of 16 weeks
Secondary	Change in time in walking	time needed to perform the 10 meters walking test (seconds)	through study completion, an average of 16 weeks
Secondary	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)	through study completion, an average of 16 weeks