Functional and MRI Evaluation of the Robot-assisted and Traditional Rehabilitation Programs on the Muscle in Subjects With Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- GMFM - T-post
研究概览
简要总结
Walk recovery is one of the goals of rehabilitation programs in patients with acquired brain injury.
Recent experiences have shown the effectiveness of rehabilitation programs including traditional physiotherapy in combination with robotic gait training systems (Lokomat).
In this context, MRI can be used to assess the treatment effects on the muscular tissue, providing useful clinical indications for the optimization of the rehabilitation programs on the basis of the damage extension and the muscle characteristics.
详细描述
Acquired brain injuries can lead to permanent physical, cognitive and psycho-social deficits. One of the primary objectives of rehabilitation in these patients is to recover the ability to walk, which is usually feasible in most patients, even in those with severe brain injuries.
Recent experiences have shown that the use of rehabilitative programs that include traditional physiotherapy in combination with robotic walking training systems (robotic-aided gait training - RAGT, Lokomat) are effective in improving the performance of pediatric patients with acquired brain injuries. Thanks to the partial or total support of the patient's weight and the robotic guidance that facilitates a physiological gait pattern, these systems allow intensive and reproducible training which, by stimulating brain neuroplasticity, can increase the chances of recovery. Alterations of strength, coordination, balance associated with structural changes of muscular tissue (e.g. atrophy, fibrosis, adipose substitution) are frequent and may, on the other hand, compromise the effectiveness of rehabilitation treatments.
There are currently no literature data regarding local effects on muscle tissue of such treatments in the pediatric population; in particular, it has not yet been documented how the muscle responds to the robotic treatment and whether it is possible to identify local indices able to correlate with the degree of performance and improvement of each patient. Magnetic Resonance Imaging (MRI) can be a useful tool for in-vivo measurement of the effects of these treatments on muscle tissue and provide clinical indications for a better optimization of rehabilitative programs, based on the extent of damage and the characteristics of the muscle.
A complete evaluation of the effects of rehabilitative programs with RAGT, both in terms of mechanical-functional data (kinematics, muscular metabolism) and structural data through MRI, and the subsequent correlation of these parameters with clinical scales measuring motor skills, is not currently described in the literature. It could instead prove to be very useful both for prognostic purposes and for a better understanding of the local mechanisms of muscle tissue response to rehabilitative treatments, favoring an identification of the best rehabilitation plan targeted for each specific patient and thus increasing the chances of functional recovery.
The objectives of the study are:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acquired brain lesion occurred in the last 10 months prior the beginning of the treatment
- •hemi or tetraparesis diagnosis following the brain lesion
- •thigh-bone length > 21 cm
- •ability and willingness to follow instructions and communicate fear and pain
排除标准
- •severe contractures, fractures, bone instability or osteoporosis of the lower limbs
- •skin lesions in the lower limbs
- •thromboembolic or cardiovascular pathologies
- •aggression and self-aggressive behavior
- •orthopedic surgery and/or botulinum toxin injection in the 6 months prior to enrollment
- •cognitive and/or motor deficits prior to the injury
- •contraindications to MRI examination
结局指标
主要结局
GMFM - T-post
时间窗: Within a week after the ent of the treatment
Gross Motor Function Measures (GMFM) acquired after the end of the treatment. (Functional measure)
Ashowrth scale - T-post
时间窗: Within a week after the ent of the treatment
Ashowrth scale acquired performed after the end of the treatment. (Functional measure)
GMFM - T-pre
时间窗: The week before the beginning of the treatment
Gross Motor Function Measures (GMFM) acquired before the beginning of the treatment. (Functional measure)
6mwt - T-post
时间窗: Within a week after the ent of the treatment
Six minute walking test (6mwt) performed after the end of the treatment. (Functional measure)
Tardieu scale - T-post
时间窗: Within a week after the ent of the treatment
Tardieu scale acquired performed after the end of the treatment. (Functional measure)
6mwt - T-pre
时间窗: The week before the beginning of the treatment
Six minute walking test (6mwt) performed before the beginning of the treatment. (Functional measure)
Ashowrth scale - T-pre
时间窗: The week before the beginning of the treatment
Ashowrth scale acquired before the beginning of the treatment. (Functional measure)
Tardieu scale - T-pre
时间窗: The week before the beginning of the treatment
Tardieu scale acquired before the beginning of the treatment. (Functional measure)
次要结局
- FF - T-post(Within a week after the end of the treatment)
- FA - T-pre(The week before the beginning of the treatment)
- MD - T-pre(The week before the beginning of the treatment)
- WF - T-pre(The week before the beginning of the treatment)
- WF - T-post(Within a week after the end of the treatment)
- FF - T-pre(The week before the beginning of the treatment)
- FA - T-post(Within a week after the end of the treatment)
- MD - T-post(Within a week after the end of the treatment)