Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-02 @ 10:27 AM
Study NCT ID:
NCT04768192
Status:
UNKNOWN
Last Update Posted:
2021-02-24
First Post:
2021-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional and MRI Evaluation of the Robot-assisted and Traditional Rehabilitation Programs on the Muscle
Sponsor:
IRCCS Eugenio Medea
Organization:
Study Overview
Official Title:
Functional and MRI Evaluation of the Robot-assisted and Traditional Rehabilitation Programs on the Muscle in Subjects With Acquired Brain Injury
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: