Clinical trial NCT04768192: Functional and MRI Evaluation of the Robot-assisted and Traditional Rehabilitation Programs on the Muscle
Official title: Functional and MRI Evaluation of the Robot-assisted and Traditional Rehabilitation Programs on the Muscle in Subjects With Acquired Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
Collaborators: name: The National Research Council, Italy
First posted: 2021-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes pediatric patients with acquired brain lesion occurred in the last 10 months prior the beginning of the treatment and showing deficit in the lower limbs movements due to the acquired lesion.

Brief summary: 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.

Detailed description: 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:

1. To characterize, in subjects with acquired cerebral lesions, the effects of intensive rehabilitative programs with RAGT, in terms of kinematics, activation and muscle metabolism;
2. To document, in subjects with acquired cerebral lesions, the effects of intensive rehabilitative programs with RAGT on muscular structure through advanced and quantitative MRI methods;
3. Correlate functional and muscle imaging data with clinical parameters related to patient's motor skills and with the type of treatment performed.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: GMFM - T-pre
timeFrame: The week before the beginning of the treatment
measure: 6mwt - T-pre
timeFrame: The week before the beginning of the treatment
measure: Ashowrth scale - T-pre
timeFrame: The week before the beginning of the treatment
measure: Tardieu scale - T-pre
timeFrame: The week before the beginning of the treatment
measure: GMFM - T-post
timeFrame: Within a week after the ent of the treatment
measure: 6mwt - T-post
timeFrame: Within a week after the ent of the treatment
measure: Ashowrth scale - T-post
timeFrame: Within a week after the ent of the treatment
measure: Tardieu scale - T-post
timeFrame: Within a week after the ent of the treatment
Secondary outcomes:
measure: WF - T-pre
timeFrame: The week before the beginning of the treatment
measure: FF - T-pre
timeFrame: The week before the beginning of the treatment
measure: FA - T-pre
timeFrame: The week before the beginning of the treatment
measure: MD - T-pre
timeFrame: The week before the beginning of the treatment
measure: WF - T-post
timeFrame: Within a week after the end of the treatment
measure: FF - T-post
timeFrame: Within a week after the end of the treatment
measure: FA - T-post
timeFrame: Within a week after the end of the treatment
measure: MD - T-post
timeFrame: Within a week after the end of the treatment
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Scientific Institute IRCCS Eugenio Medea
state: LC
Study officials:
affiliation: Research Institute IRCCS Eugenio Medea
name: Denis Peruzzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: