NCT04181918

Brief Summary

The aim of the study is to assess the role of Action Observation Treatment (AOT) and Motor Imagery (MI) in the rehabilitation of Parkinson's disease patients, as compared to a control condition. Main outcome measures will be the results in two functional scales (FIM, UPDRS) and kinematics parameters obtained from gait analysis. Data at two months and six months follow up, respectively, will be also collected.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 26, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2020

Completed
Last Updated

December 2, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

November 18, 2019

Last Update Submit

November 26, 2019

Conditions

Parkinson

Keywords

Action Observation TreatmentMotor ImageryRandomized Controlled Study

Outcome Measures

Primary Outcomes (3)

  • change in the functional status of the patient

    to assess the change in the functional status of the patient, the Functional Independence Measure (FIM) will be used. FIM consists in a 7-point scale (1 = \<25% independence; total assistance required, 7 = 100% independence), and it can detect changes in the patient's status in 18 categories, focusing on motor and cognitive function. Functional patients' status will assess before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.

    Before treatment, within one week after treatment, two months' follow up

  • change in Parkinson disease motor symptoms

    to assess the change in motor status of the patient, the Unified Parkinson's Disease Rating Scale (UPDRS) will be used, and it consists in a 5-point scale (0 = no signs; 4 = severe). UPDRS will be administered before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.

    Before treatment, within one week after treatment, two months' follow up

  • change in kinematic parameters of the gait (velocity, footing, pace, step length)

    to assess the change of patient's gait parameters, the kinematic analysis will be used (i.e. gait analysis). The gait analysis allows to detect fine-grain changes in kinematic parameters of the movement, through a non-invasive methodology. Gait analysis will be performed before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.

    Before treatment, within one week after treatment, two months' follow up

Study Arms (3)

AOT

EXPERIMENTAL

This group will observe videos depicting daily actions and afterwards they will execute the seen actions

Behavioral: AOT

MI

EXPERIMENTAL

This group will imagine motorically the same action as the first group and afterwards they will execute the imagined actions

Behavioral: MI

Control

NO INTERVENTION

This group will neither observe nor imagine actions, but simply observe videos with no motor content. Afterwards they will execute the same actions as in AOT and MI.

Interventions

AOTBEHAVIORAL

During action observation, participants observe different daily actions (e.g. reading a newspaper; drinking an espresso) divided into up to four motor segments.

AOT
MIBEHAVIORAL

During motor imagery, participants imagine themselves performing the same daily actions as in AOT in the absence of motor output

MI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson disease patients on Hoehn and Yahr 3-4

You may not qualify if:

  • Mini-Mental State Examination \< 24
  • Fluent aphasic patients
  • Apraxia
  • Neglect
  • major neuropsychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Don Carlo Gnocchi

Parma, 43123, Italy

RECRUITING

Study Officials

  • Giovanni Buccino

    Istituto Don Gnocchi

    PRINCIPAL INVESTIGATOR

  • Claudio Rovacchi

    Istituto Don Gnocchi

    STUDY CHAIR

Central Study Contacts

Giovanni Buccino

CONTACT

00390521205683neurofis.buccino@gmail.com

Claudio Rovacchi

CONTACT

00390521205683crovacchi@dongnocchi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

December 2, 2019

Study Start

March 26, 2018

Primary Completion

March 26, 2020

Study Completion

June 26, 2020

Last Updated

December 2, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)