NCT01815281

Brief Summary

The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 10, 2024

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

March 14, 2013

Last Update Submit

April 9, 2024

Conditions

Idiopathic Parkinson's DiseaseProgressive Supranuclear Palsy

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go.

    Time Up and Go test will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13).

    Change from Baseline in Timed Up and Go test at 1 month follow up.

Secondary Outcomes (4)

  • 6 minuts walking test.

    Change from Baseline in gait speed at 1 month follow up

  • Gait Parameters

    Change from Baseline in Gait Parameters at 1 month follow up

  • FREEZING OF GAIT QUESTIONNAIRES

    Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up.

  • THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39)

    Change from Baseline in PDQ-39 at 1 month follow up

Other Outcomes (5)

  • UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS).

    Change from Baseline in UPDRS scores at 1 month follow up

  • PROGRESSIVE SUPRANUCLEAR PALSY RATING SCALE (PSP RATING SCALES)

    Change from Baseline in PSP RATING SCALES scores at 1 month follow up

  • Functional Ambulation classification (FAC)

    Change from Baseline in FAC scores at 1 month follow up

  • +2 more other outcomes

Study Arms (2)

Foot Mechanical Stimulation

EXPERIMENTAL

The FMS stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).

Device: Foot Mechanical Stimulation (GONDOLA)

Footh Mechanical Stimulation

SHAM COMPARATOR

The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).

Device: Foot Mechanical Stimulation (GONDOLA)

Interventions

Foot Mechanical Stimulation (GONDOLA)DEVICE
Also known as: GONDOLA equipment (Ecker Technologies Sagl, Switzerland).
Foot Mechanical StimulationFooth Mechanical Stimulation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of idiopathic PD or PSP by UK Brain Bank criteria,
  • Able to walk 25 feet unassisted or with minimal assistance;
  • On stable doses of Parkinson's medications for at least 2 weeks prior to study onset;
  • Endurance sufficient to stand at least 20 minutes unassisted per patient report.

You may not qualify if:

  • Other significant neurological or orthopedic problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

San Raffaele Cassino

Cassino, FR, Italy

Location

University Campus Biomedico of Rome

Rome, 00128, Italy

Location

IRCCS San Raffaele Roma

Rome, 00163, Italy

Location

Related Publications (1)

  • Quattrocchi CC, de Pandis MF, Piervincenzi C, Galli M, Melgari JM, Salomone G, Sale P, Mallio CA, Carducci F, Stocchi F. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study. PLoS One. 2015 Oct 15;10(10):e0137977. doi: 10.1371/journal.pone.0137977. eCollection 2015.

    PMID: 26469868DERIVED

MeSH Terms

Conditions

Parkinson DiseaseSupranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fabrizio Stocchi, MD

    IRCCS San Raffaele Pisana Rome Italy

    PRINCIPAL INVESTIGATOR

  • Michela Goffredo, BME

    IRCCS San Raffaele Pisana Rome Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 21, 2013

Study Start

July 1, 2013

Primary Completion

November 1, 2013

Study Completion

April 1, 2015

Last Updated

April 10, 2024

Record last verified: 2015-03

Locations

IT(3)