Action Observation Plus Sonification Therapeutic Protocol

NCT03249155 | Completed

• 1 other identifier: UTrieste
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Freezing of Gait, Action Observation

Outcome Measures

Primary Outcomes (1)

• (Changes in) New Freezing of Gait Questionnaire - NFOG-Q

  Clinical Administered Questionnaire

  Before treatment, 2-months (end of treatment), 3-months, and 5-months

Secondary Outcomes (6)

• (Changes in) Unified Parkinson Disease Rating Scale - part 2, 3

  Before treatment, 2-months (end of treatment), 3-months, and 5-months

• (Changes in) BERG Balance Scale

  Before treatment, 2-months (end of treatment), 3-months, and 5-months

• (Changes in) MPAS - Modified Parkinson Assessment Scale

  Before treatment, 2-months (end of treatment), 3-months, and 5-months

• (Changes in) TUG - Time Up and Go

  Before treatment, 2-months (end of treatment), 3-months, and 5-months

• (Changes in) 6MWT - Six Minutes Walking Test

  Before treatment, 2-months (end of treatment), 3-months, and 5-months

Study Arms (2)

AO - plus sonification

EXPERIMENTAL

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

CUE - visual and auditory

ACTIVE COMPARATOR

patients re-learn 8 motor gestures practicing a traditional protocol combining visual and auditory cues.

Behavioral: CUE - visual and auditory

Interventions

AO - plus sonification BEHAVIORAL

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)

AO - plus sonification

CUE - visual and auditory BEHAVIORAL

patients re-learned 8 motor gestures practicing a traditional protocol combining visual and auditory cues

CUE - visual and auditory

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Trieste: lead

Related Publications (7)

• Pelosin E, Avanzino L, Bove M, Stramesi P, Nieuwboer A, Abbruzzese G. Action observation improves freezing of gait in patients with Parkinson's disease. Neurorehabil Neural Repair. 2010 Oct;24(8):746-52. doi: 10.1177/1545968310368685. Epub 2010 May 7.

  PMID: 20453155 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• Nutt JG, Bloem BR, Giladi N, Hallett M, Horak FB, Nieuwboer A. Freezing of gait: moving forward on a mysterious clinical phenomenon. Lancet Neurol. 2011 Aug;10(8):734-44. doi: 10.1016/S1474-4422(11)70143-0.

  PMID: 21777828 BACKGROUND

• Patla AE, Vickers JN. Where and when do we look as we approach and step over an obstacle in the travel path? Neuroreport. 1997 Dec 1;8(17):3661-5. doi: 10.1097/00001756-199712010-00002.

  PMID: 9427347 BACKGROUND

• Stefan K, Cohen LG, Duque J, Mazzocchio R, Celnik P, Sawaki L, Ungerleider L, Classen J. Formation of a motor memory by action observation. J Neurosci. 2005 Oct 12;25(41):9339-46. doi: 10.1523/JNEUROSCI.2282-05.2005.

  PMID: 16221842 BACKGROUND

• Vinken PM, Kroger D, Fehse U, Schmitz G, Brock H, Effenberg AO. Auditory coding of human movement kinematics. Multisens Res. 2013;26(6):533-52. doi: 10.1163/22134808-00002435.

  PMID: 24800411 BACKGROUND

• Schmitz G, Mohammadi B, Hammer A, Heldmann M, Samii A, Munte TF, Effenberg AO. Observation of sonified movements engages a basal ganglia frontocortical network. BMC Neurosci. 2013 Mar 14;14:32. doi: 10.1186/1471-2202-14-32.

  PMID: 23496827 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Paolo Bernardis, PhD

  University of Trieste

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 15, 2017
• Study Start: March 2, 2015
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: August 15, 2017

Record last verified: 2017-08