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Clinical Trials/NCT04181918
NCT04181918
Unknown
Not Applicable

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

Fondazione Don Carlo Gnocchi Onlus1 site in 1 country60 target enrollmentMarch 26, 2018
ConditionsParkinson

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Enrollment
60
Locations
1
Primary Endpoint
change in Parkinson disease motor symptoms
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 26, 2018
End Date
June 26, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Parkinson disease patients on Hoehn and Yahr 3-4

Exclusion Criteria

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

Outcomes

Primary Outcomes

change in Parkinson disease motor symptoms

Time Frame: 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

Time Frame: 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)

Time Frame: 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.

Study Sites (1)

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