Acquired Brain InjuryNCT05747222
Action Observation Theraphy in Severe Acquired Brain Injury.
A study testing Action Observation Tharapy and Conventional Therapy in people with Acquired Brain Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Action Observation Therapy (AOT) is a rehabilitation technique, used for several years, aimed at the recovery of motor function in patients with neurological and orthopedic conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Action Observation Tharapy and Conventional Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2021to 30 Apr 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years;
- Having presented with a documented coma state with Glasgow Coma Scale (GCS) values ≤ 8, for at least 24 consecutive hours;
- Minimal Consciousness State (MCS) or emergence from Minimal Consciousness State (eMCS)
- Presence of muscle activity in at least one upper limb,
- Traumatic, cerebrovascular, anoxic, infectious, metabolic etiology;
- Time since acute event: 1 - 4 months;
- Unilateral or bilateral clinical involvement;
Who cannot join
- Patients in a comatose or vegetative state (VS)
- premorbid history of psychiatric or neurological conditions;
- concomitant presence of sepsis, coma, or other medical conditions that severely alter the patient's health status;
- Changes in therapy, during the study period, that may affect vigilance status (antiepileptic drugs, antidepressants, etc.) or spasticity;
- Presence of upper limb fractures;
- Level of spasticity Ashworth modified≥ 3
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00168
About this study
Official title: Evaluation of the Effectiveness of Action Observation Theraphy (AOT) in Patients with Severe Acquired Brain Injury (sABI).
Action Observation Therapy (AOT) is a rehabilitation technique, used for several years, aimed at the recovery of motor function in patients with neurological and orthopedic conditions.
The essential element of this approach is the patient's observation and subsequent mime of a sequence of daily actions, aimed at achieving a goal. This task is proposed repeatedly during a single rehabilitation session and repeated for a set number of sessions. The recovery of the presented motor patterns has, as its ultimate goal, the improvement of autonomy in activities of daily living (ADLs).
The neurophysiological mechanism underlying motor cortical recovery is related to the activation of mirror neuron circuits and includes mechanisms of neuronal plasticity. In fact, it is well known how motor brain areas injured by a pathological process are able to activate during tasks of imagining or observing movements, with a correspondence between the type of movement observed and the specific motor cortical region involved in the given action. Activation of the brain areas in charge of movement, in addition to keeping the uninjured networks functioning, stimulates the injured ones by promoting, by mechanisms of neuronal plasticity, a reorganization of the primary motor cortex. The physiological basis for motor learning would thus be established, the cortical reorganization being decisive for the formation of a motor memory of the observed gesture and allowing the reacquisition, even partial, of the function of the injured motor cortex. Finally, motor cortical stimulation has a function in preventing dysfunctional cortical reorganization that intervenes after inactivity or disuse. As revealed by systematic review studies on the subject, the protocols used are very heterogeneous in terms of the type of patients to whom they were offered, the type and number of actions shown during treatments, their duration, and the rating scales used.
Read the detailed description
However, in the context of patients with neurological diseases, studies have mainly been conducted on patients with outcomes of stroke, infant cerebral palsy, and Parkinson's disease. Very few data are available in the literature on the possible efficacy of AOT in patients with severe acquired brain injury (sABI).
The advantage of AOT is that it represents a method that is noninvasive, requires readily available and low-cost instrumentation, is undemanding in terms of time and resources, and for whose application there are no known adverse reactions.
In light of the above, the purpose of the study is to evaluate the application and effectiveness of rehabilitative treatment with AOT in patients with sABI of different etiology.
The research hypotheses consist of: (i) improvement of motor function assessed by clinical and functional scales (ii) improvement of cerebral cortical activation, particularly in terms of improvement of basic rhythmic frequencies and connectivity, assessed by EEG method, after rehabilitative treatment with AOT in patients with outcomes of sABI.
- Conditions
- Acquired Brain Injury
- Being tested
- Action Observation Tharapy, Conventional Therapy
- Keywords
- Acquired Brain Injury, Disorder of Consciousness, Action Observation Therapy
- Medical subject headings
- Brain Injuries, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation TharapyOther
Using a 13-inch tablet, the patient will be shown, from a third-person lateral perspective framing the palmar side of the hand, a video that repeatedly plays a simple movement of daily life (grasping a glass on the table with the hand and bringing it closer to oneself) for 5 consecutive minutes. The video should be customized based on the side being treated (ex: right hemiparesis, video framing a right hand). After 1 minute of rest, the therapist will ask the patient to perform the newly observed movement for a minimum duration of 2 minutes and a maximum of 5 minutes. The cycle will be repeated a total of 3 times, for total treatment time between 25 and 35 minutes per session.
Conventional TherapyOther
Conventional treatment will focus on joint mobilization, muscle stretching, and neuromuscular facilitation activities, using the main rehabilitation methods (e.g., neurocognitive theory, Bobath Concept, Progressive Neuromuscular Facilitation, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Group Action Observation Therapy (G-AOT) | Experimental | G-AOT patients will carry out AOT therapy in addition to conventional rehabilitation therapies. In case of bilateral clinical engagement, treatment with AOT will have been conducted on the limb that on motor outcome measures appears less involved.
G-AOT patients will undergo rehabilitation treatment with AOT once a day, 5 days a week. 15 sessions will then be given, for a total duration of 3 weeks of experimental treatment with AOT. Receives: Other: Action Observation Tharapy; Other: Conventional Therapy |
| Group Conventional (G-CONV) | Active comparator | G-CONV patients will only carry out rehabilitation treatments as per clinical practice. Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motricity Index Upper Limb (MI-UL)
MI-UL can be used to assess the motor impairment in a patient who has had a stroke.
Test for each upper limb:
- pincer grip
- elbow flexion
- shoulder abduction
For the pincer grip:
0 points, no movement 19 points, grip possible but not against gravity 33 points, normal grip
For all other items:
0 points, no movement 14 points, Visible movement but not for the entire joint range or against gravity 19 points, movement possible for the entire joint range against gravity but not against resistance 33 points movement performed with normal force Each segment has a total score obtained by adding the value "1" to the score of each individual item. The total score then ranges from 1 (no movement) to 100 (normal movement).
Measured: Change from baseline MI-UL at 3 weeks
Secondary outcomes (8)
Motor Assessment Scale (MAS)
MAS is a performance-based scale used to assess the level of impairment and daily motor function in stroke patients. It consists of 9 items to assess areas of motor function. Each item, with the exception of the item on "general tone," is assessed with a 7-point scale (0 to 6, where 6 indicates optimal motor behavior).
For the general tone item, scoring is based on continuous observations during the assessment. A score of 4 on this item indicates a consistently normal response, a score > 4 indicates persistent hypertone, and a score < 4 indicates varying degrees of hypotone.
Item scores (except for general tone) are summed to obtain an overall score (out of 48 points).
For MAS 1 to 5, completion of a higher-level item suggests success in the lower-level items, and thus the lower items can be skipped.
The upper limb section (MAS 6-8) should be scored non-hierarchically, i.e., each item within the subsets should be scored regardless of its position in the hierarchy.
Measured: Change from baseline MAS at 3 weeks
Nine Hole Peg Test (9HPT)
9HPT is used to measure finger dexterity in patients with different neurological diagnoses. The patient should take the 9 pegs from a container, one by one, and to insert them into the holes in the board, as quickly as possible, using only the hand to be evaluated. After that, the patient should remove the pegs from the holes, one at a time, and reinsert them into the container.
The evaluator should start the stopwatch as soon as the patient touches the first peg. The evaluator should stop the stopwatch when the last peg is in the container.
Measured: Change from baseline 9HPT at 3 weeks
Coma Recovery Scale-revised (CRS-r)
CRS-r is an assessment tool that examines 6 functions: auditory, visual, oral-verbal motor, communicative, and vigilance.
Its different items are organized hierarchically (low scores represent reflex activities, high scores describe cognitively mediated behaviors).
For each function examined, the diagnosis of Vegetative State, Minimal Consciousness State, Emergence from Minimal Consciousness State can be made.
Measured: Change from baseline CRS-r at 3 weeks
Level of Cognitive Functioning (LCF)
LCF is a tool that assesses the level of cognitive and behavioural recovery. It consists of 7 items ranging from 1=no response to 8=final-appropriate.
Measured: Change from baseline LCF at 3 weeks
Glasgow Outcome Scale-Extended (GOS-E)
The Glasgow Outcome Scale- Extended (GOS-E) ranks global outcomes in TBI survivors.
The GOS-E consists of a series of discrete categories arranged in a hierarchy and does not involve the summation of individual item scores. Choice items in the hierarchy are used to decide an outcome.
The 8 categories are: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery.
Measured: Change from baseline GOS-E at 3 weeks
Disability Rating Scale (DRS)
DRS is an assessment tool for level of consciousness and functional recovery. It consists of four domains:
(i) Vigilance, awareness and responsiveness (0 to 12 points) (ii) Cognitive ability for self-care activities (0 to 9 points) (iii) Functional level (0 to 5 points) (iv) employability (0 to 3 points). A higher score corresponds to greater disability. The overall score ranges from 0 to 30 and allows the identification of 10 categories ranging from category 1 (no disability) to category 10 (death).
Measured: Change from baseline DRS at 3 weeks
Pittsburgh Partecipation Rating Scale (PPRS)
The PRPS is a 6-point Likert-type measure of observed patient participation in a therapy session. The PRPS, with a full description of each anchor point, is as follows:
Poor: The patient refused or did not participate in at least half of the session.
Fair: The patient did not complete most of the exercises. Good: The patient participated in all exercises with good effort and completed most but not all of the exercises, and passively followed directions.
Very good: the patient participated in all exercises with maximum effort and finished all exercises.
Excellent: the patient participated in all exercises with maximum effort, completed all exercises and took an active interest in the exercises and/or future therapy sessions.
Measured: Change from baseline PPRS at 3 weeks
Electrocortical Activity
The information inherent in the assessment of electrocortical activity, using the electroencephalogram (EEG), asking the patient to move the treated limb (or, if not possible, to imagine the movement). The presence of a cortical potential in motor area will be assessed by following the somatotopic organization, by reconstructing a brain map in amplitude
Measured: Change from baseline EEG at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start20 Dec 2021
- Primary completion30 Sep 2022
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PADUA LUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Luca Padua, MD, phD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747222
- Sponsor's protocol ID
- 4599
- Status last verified
- Dec 2024
- First submitted
- 17 Feb 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Action Observation Theraphy (AOT) in Patients with Severe Acquired Brain Injury (sABI).
- ClinicalTrials.gov ID
- NCT05747222
- Acronym / sponsor ID
- 4599
- Conditions
- Acquired Brain Injury
- Keywords
- Acquired Brain Injury, Disorder of Consciousness, Action Observation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 Feb 2023 (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.
Action Observation Therapy (AOT) is a rehabilitation technique, used for several years, aimed at the recovery of motor function in patients with neurological and orthopedic conditions.
The essential element of this approach is the patient's observation and subsequent mime of a sequence of daily actions, aimed at achieving a goal. This task is proposed repeatedly during a single rehabilitation session and repeated for a set number of sessions. The recovery of the presented motor patterns has, as its ultimate goal, the improvement of autonomy in activities of daily living (ADLs).
The neurophysiological mechanism underlying motor cortical recovery is related to the activation of mirror neuron circuits and includes mechanisms of neuronal plasticity. In fact, it is well known how motor brain areas injured by a pathological process are able to activate during tasks of imagining or observing movements, with a correspondence between the type of movement observed and the specific motor cortical region involved in the given action. Activation of the brain areas in charge of movement, in addition to keeping the uninjured networks functioning, stimulates the injured ones by promoting, by mechanisms of neuronal plasticity, a reorganization of the primary motor cortex. The physiological basis for motor learning would thus be established, the cortical reorganization being decisive for the formation of a motor memory of the observed gesture and allowing the reacquisition, even partial, of the function of the injured motor cortex. Finally, motor cortical stimulation has a function in preventing dysfunctional cortical reorganization that intervenes after inactivity or disuse. As revealed by systematic review studies on the subject, the protocols used are very heterogeneous in terms of the type of patients to whom they were offered, the type and number of actions shown during treatments, their duration, and the rating scales used.
Detailed description
However, in the context of patients with neurological diseases, studies have mainly been conducted on patients with outcomes of stroke, infant cerebral palsy, and Parkinson's disease. Very few data are available in the literature on the possible efficacy of AOT in patients with severe acquired brain injury (sABI).
The advantage of AOT is that it represents a method that is noninvasive, requires readily available and low-cost instrumentation, is undemanding in terms of time and resources, and for whose application there are no known adverse reactions.
In light of the above, the purpose of the study is to evaluate the application and effectiveness of rehabilitative treatment with AOT in patients with sABI of different etiology.
The research hypotheses consist of: (i) improvement of motor function assessed by clinical and functional scales (ii) improvement of cerebral cortical activation, particularly in terms of improvement of basic rhythmic frequencies and connectivity, assessed by EEG method, after rehabilitative treatment with AOT in patients with outcomes of sABI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Action Observation Therapy (G-AOT) | Experimental | Other: Action Observation Tharapy, Other: Conventional TherapyG-AOT patients will carry out AOT therapy in addition to conventional rehabilitation therapies. In case of bilateral clinical engagement, treatment with AOT will have been conducted on the limb that on motor outcome measures appears less involved. G-AOT patients will undergo rehabilitation treatment with AOT once a day, 5 days a week. 15 sessions will then be given, for a total duration of 3 weeks of experimental treatment with AOT. |
| Group Conventional (G-CONV) | Active comparator | Other: Conventional TherapyG-CONV patients will only carry out rehabilitation treatments as per clinical practice. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 80 years;
- Having presented with a documented coma state with Glasgow Coma Scale (GCS) values ≤ 8, for at least 24 consecutive hours;
- Minimal Consciousness State (MCS) or emergence from Minimal Consciousness State (eMCS)
- Presence of muscle activity in at least one upper limb,
- Traumatic, cerebrovascular, anoxic, infectious, metabolic etiology;
Key exclusion criteria (6 listed)
- Patients in a comatose or vegetative state (VS)
- premorbid history of psychiatric or neurological conditions;
- concomitant presence of sepsis, coma, or other medical conditions that severely alter the patient's health status;
- Changes in therapy, during the study period, that may affect vigilance status (antiepileptic drugs, antidepressants, etc.) or spasticity;
- Presence of upper limb fractures;
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 |
|---|---|---|
| Action Observation TharapyUsing a 13-inch tablet, the patient will be shown, from a third-person lateral perspective framing the palmar side of the hand, a video that repeatedly plays a simple movement of daily life (grasping a glass on the table with the hand and bringing it closer to oneself) for 5 consecutive minutes. The video should be customized based on the side being treated (ex: right hemiparesis, video framing a right hand). After 1 minute of rest, the therapist will ask the patient to perform the newly observed movement for a minimum duration of 2 minutes and a maximum of 5 minutes. The cycle will be repeated a total of 3 times, for total treatment time between 25 and 35 minutes per session. | Other | Group Action Observation Therapy (G-AOT) |
| Conventional TherapyConventional treatment will focus on joint mobilization, muscle stretching, and neuromuscular facilitation activities, using the main rehabilitation methods (e.g., neurocognitive theory, Bobath Concept, Progressive Neuromuscular Facilitation, etc.). | Other | Group Action Observation Therapy (G-AOT), Group Conventional (G-CONV) |
Primary outcome
Motricity Index Upper Limb (MI-UL)
Time frame: Change from baseline MI-UL at 3 weeks
MI-UL can be used to assess the motor impairment in a patient who has had a stroke. Test for each upper limb: 1. pincer grip 2. elbow flexion 3. shoulder abduction For the pincer grip: 0 points, no movement 19 points, grip possible but not against gravity 33 points, normal grip For all other items: 0 points, no movement 14 points, Visible movement but not for the entire joint range or against gravity 19 points, movement possible for the entire joint range against gravity but not against resistance 33 points movement performed with normal force Each segment has a total score obtained by adding the value "1" to the score of each individual item. The total score then ranges from 1 (no movement) to 100 (normal movement).
8 secondary outcomes
Motor Assessment Scale (MAS)
Time frame: Change from baseline MAS at 3 weeks
Nine Hole Peg Test (9HPT)
Time frame: Change from baseline 9HPT at 3 weeks
Coma Recovery Scale-revised (CRS-r)
Time frame: Change from baseline CRS-r at 3 weeks
Level of Cognitive Functioning (LCF)
Time frame: Change from baseline LCF at 3 weeks
Glasgow Outcome Scale-Extended (GOS-E)
Time frame: Change from baseline GOS-E at 3 weeks
Disability Rating Scale (DRS)
Time frame: Change from baseline DRS at 3 weeks
Pittsburgh Partecipation Rating Scale (PPRS)
Time frame: Change from baseline PPRS at 3 weeks
Electrocortical Activity
Time frame: Change from baseline EEG at 3 weeks
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 20 Mar 2025.
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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.
Luca Padua, MD, phD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Tharapy and Conventional Therapy in people with Acquired Brain Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 7 inclusion and 6 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 20 Mar 2025. 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?
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?
Motricity Index Upper Limb (MI-UL) (time frame: Change from baseline MI-UL at 3 weeks). 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 20 Mar 2025.