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Action Observation Plus Sonification Therapeutic Protocol (AOFREEPD)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AO - plus sonification
CUE - visual and auditory
Sponsored by
University of Trieste
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Freezing of Gait, Action Observation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    AO - plus sonification

    CUE - visual and auditory

    Arm Description

    patients re-learn 8 motor gestures watching video-clips showing an actor performing the same gestures, and then tried to repeat the gesture.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 7, 2017
    Last Updated
    August 10, 2017
    Sponsor
    University of Trieste
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03249155
    Brief Title
    Action Observation Plus Sonification Therapeutic Protocol
    Acronym
    AOFREEPD
    Official Title
    Action Observation Plus Sonification. A Novel Therapeutic Protocol for Parkinson's Patient With Freezing of Gait
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2, 2015 (Actual)
    Primary Completion Date
    July 3, 2017 (Actual)
    Study Completion Date
    July 3, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Trieste

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Freezing of Gait, Action Observation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AO - plus sonification
    Arm Type
    Experimental
    Arm Description
    patients re-learn 8 motor gestures watching video-clips showing an actor performing the same gestures, and then tried to repeat the gesture.
    Arm Title
    CUE - visual and auditory
    Arm Type
    Active Comparator
    Arm Description
    patients re-learn 8 motor gestures practicing a traditional protocol combining visual and auditory cues.
    Intervention Type
    Behavioral
    Intervention Name(s)
    AO - plus sonification
    Intervention Description
    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)
    Intervention Type
    Behavioral
    Intervention Name(s)
    CUE - visual and auditory
    Intervention Description
    patients re-learned 8 motor gestures practicing a traditional protocol combining visual and auditory cues
    Primary Outcome Measure Information:
    Title
    (Changes in) New Freezing of Gait Questionnaire - NFOG-Q
    Description
    Clinical Administered Questionnaire
    Time Frame
    Before treatment, 2-months (end of treatment), 3-months, and 5-months
    Secondary Outcome Measure Information:
    Title
    (Changes in) Unified Parkinson Disease Rating Scale - part 2, 3
    Description
    Clinical Administered Scale
    Time Frame
    Before treatment, 2-months (end of treatment), 3-months, and 5-months
    Title
    (Changes in) BERG Balance Scale
    Description
    Clinical Administered Scale
    Time Frame
    Before treatment, 2-months (end of treatment), 3-months, and 5-months
    Title
    (Changes in) MPAS - Modified Parkinson Assessment Scale
    Description
    Clinical Administered Scale
    Time Frame
    Before treatment, 2-months (end of treatment), 3-months, and 5-months
    Title
    (Changes in) TUG - Time Up and Go
    Description
    Clinical Administered Test
    Time Frame
    Before treatment, 2-months (end of treatment), 3-months, and 5-months
    Title
    (Changes in) 6MWT - Six Minutes Walking Test
    Description
    Clinical Administered Test
    Time Frame
    Before treatment, 2-months (end of treatment), 3-months, and 5-months
    Title
    (Changes in) PDQ-39 - Parkinson Disease Quality of Life Questionnaire
    Description
    39 Items Self Administered Questionnaire
    Time Frame
    Before treatment, 2-months (end of treatment), 3-months, and 5-months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paolo Bernardis, PhD
    Organizational Affiliation
    University of Trieste
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20453155
    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.
    Results Reference
    background
    PubMed Identifier
    17695343
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21777828
    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.
    Results Reference
    background
    PubMed Identifier
    9427347
    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. doi: 10.1097/00001756-199712010-00002.
    Results Reference
    background
    PubMed Identifier
    16221842
    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. doi: 10.1523/JNEUROSCI.2282-05.2005.
    Results Reference
    background
    PubMed Identifier
    24800411
    Citation
    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. Erratum In: Multisens Res. 2014;27(3-4):263-4.
    Results Reference
    background
    PubMed Identifier
    23496827
    Citation
    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.
    Results Reference
    background

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    Action Observation Plus Sonification Therapeutic Protocol

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