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
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Freezing of Gait, Action Observation
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
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
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
Learn more about this trial
Action Observation Plus Sonification Therapeutic Protocol
We'll reach out to this number within 24 hrs