Evaluation of the Effectiveness of Action Observation Theraphy (AOT) in Patients with Severe Acquired Brain Injury (sABI).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Motricity Index Upper Limb (MI-UL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Action Observation Tharapy (Other)
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.
干预措施: Conventional Therapy (Other)
Group Conventional (G-CONV)
G-CONV patients will only carry out rehabilitation treatments as per clinical practice.
干预措施: Conventional Therapy (Other)
结局指标
主要结局
Motricity Index Upper Limb (MI-UL)
时间窗: 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).
次要结局
- Motor Assessment Scale (MAS)(Change from baseline MAS at 3 weeks)
- Level of Cognitive Functioning (LCF)(Change from baseline LCF at 3 weeks)
- Disability Rating Scale (DRS)(Change from baseline DRS at 3 weeks)
- Coma Recovery Scale-revised (CRS-r)(Change from baseline CRS-r at 3 weeks)
- Glasgow Outcome Scale-Extended (GOS-E)(Change from baseline GOS-E at 3 weeks)
- Pittsburgh Partecipation Rating Scale (PPRS)(Change from baseline PPRS at 3 weeks)
- Nine Hole Peg Test (9HPT)(Change from baseline 9HPT at 3 weeks)
- Electrocortical Activity(Change from baseline EEG at 3 weeks)
研究者
PADUA LUCA
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS