Action Observation Treatment in Parkinson's Patients

Not Applicable

• Conditions: Parkinson
• Interventions: Behavioral: AOT; Behavioral: MI

• Registration Number: NCT04181918
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-26
• Status Verified: 2019-05
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-26
• Last Update Submitted: 2019-11-26
• Study First Posted: 2019-12-02
• Last Update Posted: 2019-12-02
• Primary Completion: 2020-03-26
• Study Completion: 2020-06-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AOT	AOT	This group will observe videos depicting daily actions and afterwards they will execute the seen actions
MI	MI	This group will imagine motorically the same action as the first group and afterwards they will execute the imagined actions

Primary Outcome Measures

Name	Time	Method
change in Parkinson disease motor symptoms	Before treatment, within one week after treatment, two months' follow up	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.
change in the functional status of the patient	Before treatment, within one week after treatment, two months' follow up	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.
change in kinematic parameters of the gait (velocity, footing, pace, step length)	Before treatment, within one week after treatment, two months' follow up	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.

Trial Locations

Locations (1)

Fondazione Don Carlo Gnocchi; 🇮🇹 Parma, Italy