Parkinson DiseaseAOFREEPDNCT03249155
Action Observation Plus Sonification Therapeutic Protocol
A study testing AO - plus sonification and CUE - visual and auditory in people with Parkinson Disease, run by University of Trieste.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- AO - plus sonification and CUE - visual and auditory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2015to 3 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- dementia: MMSE > or = to 24
- past neuropathies, ictus or myelopathies
- orthopaedic comorbidity that may impede walking
- presence of DBS
- severe psychiatric pathology
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- AO - plus sonification, CUE - visual and auditory
- Keywords
- Freezing of Gait, Action Observation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AO - plus sonificationBehavioural
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 auditoryBehavioural
patients re-learned 8 motor gestures practicing a traditional protocol combining visual and auditory cues
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: CUE - visual and auditory |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Changes in) New Freezing of Gait Questionnaire - NFOG-Q
Clinical Administered Questionnaire
Measured: 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
Clinical Administered Scale
Measured: Before treatment, 2-months (end of treatment), 3-months, and 5-months
(Changes in) BERG Balance Scale
Clinical Administered Scale
Measured: Before treatment, 2-months (end of treatment), 3-months, and 5-months
(Changes in) MPAS - Modified Parkinson Assessment Scale
Clinical Administered Scale
Measured: Before treatment, 2-months (end of treatment), 3-months, and 5-months
(Changes in) TUG - Time Up and Go
Clinical Administered Test
Measured: Before treatment, 2-months (end of treatment), 3-months, and 5-months
(Changes in) 6MWT - Six Minutes Walking Test
Clinical Administered Test
Measured: Before treatment, 2-months (end of treatment), 3-months, and 5-months
(Changes in) PDQ-39 - Parkinson Disease Quality of Life Questionnaire
39 Items Self Administered Questionnaire
Measured: Before treatment, 2-months (end of treatment), 3-months, and 5-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start2 Mar 2015
- Primary completion3 Jul 2017
- Study completion3 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Bernardis, University of Trieste
- Investigators
- Paolo Bernardis, PhD, Principal investigator, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249155
- Sponsor's protocol ID
- UTrieste
- Acronym
- AOFREEPD
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20453155Faul 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.
PubMed 17695343Nutt 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.
PubMed 21777828Patla 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.
PubMed 9427347Stefan 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.
PubMed 16221842Vinken 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.
PubMed 24800411Schmitz 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.
PubMed 23496827
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action Observation Plus Sonification. A Novel Therapeutic Protocol for Parkinson's Patient With Freezing of Gait
- ClinicalTrials.gov ID
- NCT03249155
- Acronym / sponsor ID
- AOFREEPD / UTrieste
- Conditions
- Parkinson Disease
- Keywords
- Freezing of Gait, Action Observation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AO - plus sonification | Experimental | Behavioral: AO - plus sonificationpatients re-learn 8 motor gestures watching video-clips showing an actor performing the same gestures, and then tried to repeat the gesture. |
| CUE - visual and auditory | Active comparator | Behavioral: CUE - visual and auditorypatients re-learn 8 motor gestures practicing a traditional protocol combining visual and auditory cues. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- dementia: MMSE > or = to 24
- past neuropathies, ictus or myelopathies
- orthopaedic comorbidity that may impede walking
- presence of DBS
- severe psychiatric pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AO - plus sonificationpatients 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) | Behavioural | AO - plus sonification |
| CUE - visual and auditorypatients re-learned 8 motor gestures practicing a traditional protocol combining visual and auditory cues | Behavioural | CUE - visual and auditory |
Primary outcome
(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
6 secondary outcomes
(Changes in) Unified Parkinson Disease Rating Scale - part 2, 3
Time frame: 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
(Changes in) MPAS - Modified Parkinson Assessment Scale
Time frame: 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
(Changes in) 6MWT - Six Minutes Walking Test
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Background: PubMed 20453155Pelosin 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.
- Background: PubMed 17695343Faul 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.
- Background: PubMed 21777828Nutt 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.
- Background: PubMed 9427347Patla 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.
- Background: PubMed 16221842Stefan 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.
- Background: PubMed 24800411Vinken 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.
- Background: PubMed 23496827Schmitz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Bernardis, PhD principal investigator
University of Trieste
Questions about this trial
What is this clinical trial studying?
A study testing AO - plus sonification and CUE - visual and auditory in people with Parkinson Disease, run by University of Trieste.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Changes in) New Freezing of Gait Questionnaire - NFOG-Q (time frame: Before treatment, 2-months (end of treatment), 3-months, and 5-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03249155, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.