Action Observation Theraphy in Severe Acquired Brain Injury.

NCT05747222 | Completed

• 1 other identifier: 4599
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury

Keywords

Acquired Brain Injury; Disorder of Consciousness; Action Observation Therapy

Outcome Measures

Primary Outcomes (1)

• 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: 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).

  Change from baseline MI-UL at 3 weeks

Secondary Outcomes (8)

• Motor Assessment Scale (MAS)

  Change from baseline MAS at 3 weeks

• Nine Hole Peg Test (9HPT)

  Change from baseline 9HPT at 3 weeks

• Coma Recovery Scale-revised (CRS-r)

  Change from baseline CRS-r at 3 weeks

• Level of Cognitive Functioning (LCF)

  Change from baseline LCF at 3 weeks

• Glasgow Outcome Scale-Extended (GOS-E)

  Change from baseline GOS-E at 3 weeks

Study Arms (2)

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.

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.

Other: Conventional Therapy

Interventions

Action Observation Tharapy 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.

Group Action Observation Therapy (G-AOT)

Conventional Therapy 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 Action Observation Therapy (G-AOT); Group Conventional (G-CONV)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Luca Padua, MD, phD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 28, 2023
• Study Start: December 20, 2021
• Primary Completion: September 30, 2022
• Study Completion: April 30, 2024
• Last Updated: March 20, 2025

Record last verified: 2024-12

Locations

IT (1)