Action Observation Treatment in Parkinson's Patients

Parkinson Clinical Trial

— AOT-PA  

Official title:

Action Observation Treatment and Motor Imagery as Rehabilitation Tools in Parkinson's Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04181918
• Other study ID #: AOTPRFDG
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: June 26, 2020

Study information

• Verified date: May 2019
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Giovanni Buccino
• Phone: 00390521205683
• Email: neurofis.buccino[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 26, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parkinson disease patients on Hoehn and Yahr 3-4

Exclusion Criteria:

• Mini-Mental State Examination < 24

• Fluent aphasic patients

• Apraxia

• Neglect

• major neuropsychiatric disorders

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease

Intervention

Behavioral:
• AOT
During action observation, participants observe different daily actions (e.g. reading a newspaper; drinking an espresso) divided into up to four motor segments.
• MI
During motor imagery, participants imagine themselves performing the same daily actions as in AOT in the absence of motor output

Locations

Country	Name	City	State
Italy	Fondazione Don Carlo Gnocchi	Parma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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