Action Observation Plus Sonification Therapeutic Protocol

Parkinson Disease Clinical Trial

— AOFREEPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249155
• Other study ID #: UTrieste
• Status: Completed
• Phase: N/A
• First received: August 7, 2017
• Last updated: August 10, 2017
• Start date: March 2, 2015
• Est. completion date: July 3, 2017

Study information

• Verified date: August 2017
• Source: University of Trieste
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 3, 2017
• Est. primary completion date: July 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Trieste

References & Publications (7)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Schmitz G, Mohammadi B, Hammer A, Heldmann M, Samii A, Münte 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. — View Citation

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. — View Citation

Vinken PM, Kröger D, Fehse U, Schmitz G, Brock H, Effenberg AO. Auditory coding of human movement kinematics. Multisens Res. 2013;26(6):533-52. Erratum in: Multisens Res. 2014;27(3-4):263-4. — View Citation

Outcome

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