ParkinsonAOT-PANCT04181918
Action Observation Treatment in Parkinson's Patients
A study testing AOT and MI in people with Parkinson, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The aim of the study is to assess the role of Action Observation Treatment (AOT) and Motor Imagery (MI) in the rehabilitation of Parkinson's disease patients, as compared to a control condition. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson
- What is being tested?
- AOT and MI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 26 Mar 2018to 26 Jun 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parkinson disease patients on Hoehn and Yahr 3-4
Who cannot join
- Mini-Mental State Examination < 24
- Fluent aphasic patients
- Apraxia
- Neglect
- major neuropsychiatric disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Don Carlo Gnocchi
Parma, 43123
Maria Grazia Burinato, 00390521205589, mburinato@dongnocchi.it
About this study
Official title: Action Observation Treatment and Motor Imagery as Rehabilitation Tools in Parkinson's Disease Patients
The aim of the study is to assess the role of Action Observation Treatment (AOT) and Motor Imagery (MI) in the rehabilitation of Parkinson's disease patients, as compared to a control condition. Main outcome measures will be the results in two functional scales (FIM, UPDRS) and kinematics parameters obtained from gait analysis. Data at two months and six months follow up, respectively, will be also collected.
- Conditions
- Parkinson
- Being tested
- AOT, MI
- Keywords
- Action Observation Treatment, Motor Imagery, Randomized Controlled Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOTBehavioural
During action observation, participants observe different daily actions (e.g. reading a newspaper; drinking an espresso) divided into up to four motor segments.
MIBehavioural
During motor imagery, participants imagine themselves performing the same daily actions as in AOT in the absence of motor output
| Study group | Role | What they receive |
|---|---|---|
| AOT | Experimental | This group will observe videos depicting daily actions and afterwards they will execute the seen actions Receives: Behavioral: AOT |
| MI | Experimental | This group will imagine motorically the same action as the first group and afterwards they will execute the imagined actions Receives: Behavioral: MI |
| Control | No intervention | This group will neither observe nor imagine actions, but simply observe videos with no motor content. Afterwards they will execute the same actions as in AOT and MI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the functional status of the patient
to assess the change in the functional status of the patient, the Functional Independence Measure (FIM) will be used. FIM consists in a 7-point scale (1 = <25% independence; total assistance required, 7 = 100% independence), and it can detect changes in the patient's status in 18 categories, focusing on motor and cognitive function. Functional patients' status will assess before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.
Measured: Before treatment, within one week after treatment, two months' follow up
change in Parkinson disease motor symptoms
to assess the change in motor status of the patient, the Unified Parkinson's Disease Rating Scale (UPDRS) will be used, and it consists in a 5-point scale (0 = no signs; 4 = severe). UPDRS will be administered before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.
Measured: Before treatment, within one week after treatment, two months' follow up
change in kinematic parameters of the gait (velocity, footing, pace, step length)
to assess the change of patient's gait parameters, the kinematic analysis will be used (i.e. gait analysis). The gait analysis allows to detect fine-grain changes in kinematic parameters of the movement, through a non-invasive methodology. Gait analysis will be performed before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.
Measured: Before treatment, within one week after treatment, two months' follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start26 Mar 2018
- Primary completion26 Mar 2020 (estimated)
- Study completion26 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Buccino, Principal investigator, Istituto Don GnocchiClaudio Rovacchi, Study chair, Istituto Don Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181918
- Sponsor's protocol ID
- AOTPRFDG
- Acronym
- AOT-PA
- Status last verified
- May 2019
- First submitted
- 18 Nov 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action Observation Treatment and Motor Imagery as Rehabilitation Tools in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT04181918
- Acronym / sponsor ID
- AOT-PA / AOTPRFDG
- Conditions
- Parkinson
- Keywords
- Action Observation Treatment, Motor Imagery, Randomized Controlled Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 26 Mar 2020 (estimated)
- Study completion
- 26 Jun 2020 (estimated)
- First posted
- 2 Dec 2019 (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 aim of the study is to assess the role of Action Observation Treatment (AOT) and Motor Imagery (MI) in the rehabilitation of Parkinson's disease patients, as compared to a control condition. Main outcome measures will be the results in two functional scales (FIM, UPDRS) and kinematics parameters obtained from gait analysis. Data at two months and six months follow up, respectively, will be also collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AOT | Experimental | Behavioral: AOTThis group will observe videos depicting daily actions and afterwards they will execute the seen actions |
| MI | Experimental | Behavioral: MIThis group will imagine motorically the same action as the first group and afterwards they will execute the imagined actions |
| Control | No intervention | –This group will neither observe nor imagine actions, but simply observe videos with no motor content. Afterwards they will execute the same actions as in AOT and MI. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parkinson disease patients on Hoehn and Yahr 3-4
Key exclusion criteria (5 listed)
- Mini-Mental State Examination < 24
- Fluent aphasic patients
- Apraxia
- Neglect
- major neuropsychiatric disorders
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 |
|---|---|---|
| AOTDuring action observation, participants observe different daily actions (e.g. reading a newspaper; drinking an espresso) divided into up to four motor segments. | Behavioural | AOT |
| MIDuring motor imagery, participants imagine themselves performing the same daily actions as in AOT in the absence of motor output | Behavioural | MI |
Primary outcome
change in the functional status of the patient
Time frame: Before treatment, within one week after treatment, two months' follow up
to assess the change in the functional status of the patient, the Functional Independence Measure (FIM) will be used. FIM consists in a 7-point scale (1 = <25% independence; total assistance required, 7 = 100% independence), and it can detect changes in the patient's status in 18 categories, focusing on motor and cognitive function. Functional patients' status will assess before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.
change in Parkinson disease motor symptoms
Time frame: Before treatment, within one week after treatment, two months' follow up
to assess the change in motor status of the patient, the Unified Parkinson's Disease Rating Scale (UPDRS) will be used, and it consists in a 5-point scale (0 = no signs; 4 = severe). UPDRS will be administered before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.
change in kinematic parameters of the gait (velocity, footing, pace, step length)
Time frame: Before treatment, within one week after treatment, two months' follow up
to assess the change of patient's gait parameters, the kinematic analysis will be used (i.e. gait analysis). The gait analysis allows to detect fine-grain changes in kinematic parameters of the movement, through a non-invasive methodology. Gait analysis will be performed before treatment, within one week after the end of the treatment (after treatment) and two months' follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Giovanni Buccino principal investigator
Istituto Don Gnocchi
Claudio Rovacchi study chair
Istituto Don Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AOT and MI in people with Parkinson, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Buccino (00390521205683 ext. 0039, neurofis.buccino@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the functional status of the patient (time frame: Before treatment, within one week after treatment, two months' follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2019.