Action Observation Theraphy in Severe Acquired Brain Injury.

NCT ID: NCT05747222

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2024-04-30

Brief 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.

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.

Conditions

Acquired Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group Action Observation Therapy (G-AOT)

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.

Group Type: EXPERIMENTAL

Action Observation Tharapy

Intervention Type: OTHER

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 Therapy

Intervention Type: OTHER

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.).

Group Conventional (G-CONV)

G-CONV patients will only carry out rehabilitation treatments as per clinical practice.

Group Type: ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type: OTHER

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.).

Interventions

Action Observation Tharapy

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.

Intervention Type: OTHER

Conventional Therapy

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.).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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;

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

PADUA LUCA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Padua, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

Countries

Italy

Other Identifiers

4599

Identifier Type: -

Identifier Source: org_study_id