Action Observation Plus Sonification Therapeutic Protocol (AOFREEPD)

August 10, 2017 updated by: Paolo Bernardis, University of Trieste

Action Observation Plus Sonification. A Novel Therapeutic Protocol for Parkinson's Patient With Freezing of Gait

The target of this clinical trial is Freezing of Gait symptom (FoG), and associated falls. The project is aimed to evaluate the effects of an innovative experimental protocol to treat Parkinson (PD) Patients with FoG. This new physiotherapy protocol is based on the recovery of the correct mental representation of the movement, through Action Observation. A method that can facilitate the process of re-learning correct motor strategies, and at the same time avoid the phenomena of external cues dependency. Our version of the Action observation method uses video-clips of gait exercises. In these video-clips the audio part was obtained with the sonification of the kinematics of the body movements. We postulate that action observation, through the activation of the mirror system, is able to reactivate stored motor programs concerning walking ability, which can be used to facilitate recovery of defective motor control and overcome freezing of gait. Moreover, given that patients with PD and FoG may have major shortages of attention resources, a multisensory approach (audio-visual) would help to further reduce the attention load, facilitating learning processes. Therefore half of participants received an experimental protocol with Action Observation plus signification while the other half received a traditional protocol combining visual and auditory cues.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

FoG is a disabling and distressing symptom strictly associated to falls. The little or no pharmacological responsiveness of FoG has led to an increasing interest in rehabilitation interventions aimed at functional recovery and autonomy. Currently, standard protocols employed for rehabilitation are based on the use of external (visual and auditory) sensory cues. However, cued strategies generate an important dependence on the environment. Teaching motor strategies without cues (i.e. action observation - AO) can be an alternative/innovative approach to rehabilitation, that matters most on appropriate allocation of attention and lightening cognitive load. One way to increase the effectiveness of AO, is the use of a multisensory learning mode (visual and auditory) to facilitate the recovery of motor gestures thanks to enhanced perceptual processes, which is known to be reduced in PD with FoG. Sonification could be an important method to enhance therapeutical effects in action observation rehabilitation process. Sonification of movements amplifies the activity of the human action observation system including subcortical structures of the motor loop.

Methods. We compared the effects of two different therapeutic protocols. The experimental protocol was based on action observation plus sonification; patients of the experimental group re-learned 8 motor gestures watching video-clips showing an actor performing the same gestures, and then tried to repeat the gesture. Each video-clip was composed by images and sounds of the gestures. The sounds of gestures were obtained with the sonification technique, by transforming kinematic data (velocity) recorded during the execution of gesture, into pitch variations (for an example see: bit.ly/sonif_example). The same 8 motor gestures were re-learned in the standard protocol, with a common sensory stimulation method (active comparator group). We evaluated all patients of the two groups with functional and clinical scales before, immediately after, at 1 month, and 3 months after each treatment.The duration of each protocol will be about 2 months, 15 sessions, 2 times a week.

Data Safety Monitoring Plan. The patients' assignment to the two groups was as follow: a list of 20 patients (10 patients for each group) was created and the order fully randomized. The list was filled with the patients following the order of arrival from the Neurology Clinic (Cattinara Hospital, Trieste). All the evaluations (neuropsychological, neurological, and physiotherapy) are blind respect to the patient's group assignment. The person in charge to make assignment patient-treatment will not be the PI.

Sample size calculation. The dependent variable (the primary outcome measure) is the score of the N-FOG Questionnaire. Sample size has been calculated considering a repeated measures mixed ANOVA of the primary outcome measure, with the software G*Power 3. The result gives a sample size of 20 patients: 10 for each group (experimental and active comparator group). The sizing of the sample is justified by similar protocols evaluations that with an identical sample size (n = 10 per group) found statistically significant results.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parkinson's Disease Diagnosis (UK Brain Bank)
  • H&R stage < or = to 3;
  • score of 1 on the 1st question of the NFOG-Q;
  • no comorbidities that would preclude physiotherapy treatment;
  • Back Depression Scale score < or = to 16;
  • stabilized pharmacological therapy

Exclusion Criteria:

  • dementia: MMSE > or = to 24
  • past neuropathies, ictus or myelopathies
  • orthopaedic comorbidity that may impede walking
  • presence of DBS
  • severe psychiatric pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AO - plus sonification
patients re-learn 8 motor gestures watching video-clips showing an actor performing the same gestures, and then tried to repeat the gesture.
Behavioral: AO - plus sonification
patients re-learn 8 motor gestures watching video-clips showing an actor performing the same gestures, and then tried to repeat the gesture. Each video-clip is composed by images and sounds of the gestures. The sound of gestures is obtained with the sonification technique, by transforming kinematic data (velocity) recorded during the execution of gesture, into pitch variations (for an example see: bit.ly/sonif_example)
Active Comparator: CUE - visual and auditory
patients re-learn 8 motor gestures practicing a traditional protocol combining visual and auditory cues.
Behavioral: CUE - visual and auditory
patients re-learned 8 motor gestures practicing a traditional protocol combining visual and auditory cues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Changes in) New Freezing of Gait Questionnaire - NFOG-Q
Time Frame: Before treatment, 2-months (end of treatment), 3-months, and 5-months
Clinical Administered Questionnaire
Before treatment, 2-months (end of treatment), 3-months, and 5-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Changes in) Unified Parkinson Disease Rating Scale - part 2, 3
Time Frame: Before treatment, 2-months (end of treatment), 3-months, and 5-months
Clinical Administered Scale
Before treatment, 2-months (end of treatment), 3-months, and 5-months
(Changes in) BERG Balance Scale
Time Frame: Before treatment, 2-months (end of treatment), 3-months, and 5-months
Clinical Administered Scale
Before treatment, 2-months (end of treatment), 3-months, and 5-months
(Changes in) MPAS - Modified Parkinson Assessment Scale
Time Frame: Before treatment, 2-months (end of treatment), 3-months, and 5-months
Clinical Administered Scale
Before treatment, 2-months (end of treatment), 3-months, and 5-months
(Changes in) TUG - Time Up and Go
Time Frame: Before treatment, 2-months (end of treatment), 3-months, and 5-months
Clinical Administered Test
Before treatment, 2-months (end of treatment), 3-months, and 5-months
(Changes in) 6MWT - Six Minutes Walking Test
Time Frame: Before treatment, 2-months (end of treatment), 3-months, and 5-months
Clinical Administered Test
Before treatment, 2-months (end of treatment), 3-months, and 5-months
(Changes in) PDQ-39 - Parkinson Disease Quality of Life Questionnaire
Time Frame: Before treatment, 2-months (end of treatment), 3-months, and 5-months
39 Items Self Administered Questionnaire
Before treatment, 2-months (end of treatment), 3-months, and 5-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Trieste

Investigators

  • Principal Investigator: Paolo Bernardis, PhD, University of Trieste

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2015

Primary Completion (Actual)

July 3, 2017

Study Completion (Actual)

July 3, 2017

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTrieste

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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