- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04768192
Functional and MRI Evaluation of the Robot-assisted and Traditional Rehabilitation Programs on the Muscle
Functional and MRI Evaluation of the Robot-assisted and Traditional Rehabilitation Programs on the Muscle in Subjects With Acquired Brain Injury
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- To characterize, in subjects with acquired cerebral lesions, the effects of intensive rehabilitative programs with RAGT, in terms of kinematics, activation and muscle metabolism;
- 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;
- Correlate functional and muscle imaging data with clinical parameters related to patient's motor skills and with the type of treatment performed.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Denis Peruzzo, PhD
- Phone Number: +39031877939
- Email: denis.peruzzo@lanostrafamiglia.it
Study Locations
-
-
LC
-
Bosisio Parini, LC, Italy, 23842
- Recruiting
- Scientific Institute IRCCS Eugenio Medea
-
Contact:
- Denis Peruzzo, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pediatric patients with acquired brain injury
Subjects with a acquired brain injury occurred in the last 10 months prior the beginning of the treatment
|
Conventional physiotherapy is performed in 10 weekly sessions (45 minutes each) over 4 weeks(total 40 sessions). Specific exercises are administered to improve gait, balance and functional abilities focusing on: strengthening the gluteus and quadriceps muscles stretching the hip flexor and hamstrings muscles increasing static balance increasing dynamic balance increasing functional abilities improving ground gait going up and down the stairs. Physiotherapists can choose from a list of 25 standard exercises, according to some constraints:
Physiotherapists of the treatments group discuss patients' diaries during weekly meetings.
Other Names:
The rehabilitation protocol consists of 20 sessions of robotic training alternated with 20 sessions of conventional physiotherapy (CP). Each treatment is performed in 5 weekly sessions (45 minutes each) over 4 weeks. Robotic training aimed to recovery/improve walking capacity from the initial Gross Motor Function Classification System (GMFCS) level. It is performed using the Lokomat® (Hocoma AG, Volketswil, Switzerland) gait orthosis. Initial set ups includes 50% body weight unload, gait velocity adjusted on the patient individual capability (1.5 km/h on average) and 100% guidance force. Both weight unload and guidance force are gradually reduced across sessions according to patient recovery of muscle strength and allowing patients to work harden and move more freely. Children engagement, active participation and motivation were reinforced through frequent encouragement by therapists and performance feedback implemented in the exercise video-games.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GMFM - T-pre
Time Frame: The week before the beginning of the treatment
|
Gross Motor Function Measures (GMFM) acquired before the beginning of the treatment.
(Functional measure)
|
The week before the beginning of the treatment
|
6mwt - T-pre
Time Frame: The week before the beginning of the treatment
|
Six minute walking test (6mwt) performed before the beginning of the treatment.
(Functional measure)
|
The week before the beginning of the treatment
|
Ashowrth scale - T-pre
Time Frame: The week before the beginning of the treatment
|
Ashowrth scale acquired before the beginning of the treatment.
(Functional measure)
|
The week before the beginning of the treatment
|
Tardieu scale - T-pre
Time Frame: The week before the beginning of the treatment
|
Tardieu scale acquired before the beginning of the treatment.
(Functional measure)
|
The week before the beginning of the treatment
|
GMFM - T-post
Time Frame: Within a week after the ent of the treatment
|
Gross Motor Function Measures (GMFM) acquired after the end of the treatment.
(Functional measure)
|
Within a week after the ent of the treatment
|
6mwt - T-post
Time Frame: Within a week after the ent of the treatment
|
Six minute walking test (6mwt) performed after the end of the treatment.
(Functional measure)
|
Within a week after the ent of the treatment
|
Ashowrth scale - T-post
Time Frame: Within a week after the ent of the treatment
|
Ashowrth scale acquired performed after the end of the treatment.
(Functional measure)
|
Within a week after the ent of the treatment
|
Tardieu scale - T-post
Time Frame: Within a week after the ent of the treatment
|
Tardieu scale acquired performed after the end of the treatment.
(Functional measure)
|
Within a week after the ent of the treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WF - T-pre
Time Frame: The week before the beginning of the treatment
|
Water fraction (WF) in the muscular bundles measured from MRI Dixon data acquired before the beginning of the treatment
|
The week before the beginning of the treatment
|
FF - T-pre
Time Frame: The week before the beginning of the treatment
|
Fat fraction (FF) in the muscular bundles measured from MRI Dixon data acquired before the beginning of the treatment
|
The week before the beginning of the treatment
|
FA - T-pre
Time Frame: The week before the beginning of the treatment
|
Fractional Anisotropy (FA) in the muscular bundles measured from MRI Diffusion data acquired before the beginning of the treatment
|
The week before the beginning of the treatment
|
MD - T-pre
Time Frame: The week before the beginning of the treatment
|
Mean Diffusivity (MD) in the muscular bundles measured from MRI Diffusion data acquired before the beginning of the treatment
|
The week before the beginning of the treatment
|
WF - T-post
Time Frame: Within a week after the end of the treatment
|
Water fraction (WF) in the muscular bundles measured from MRI Dixon data acquired at the end of the treatment
|
Within a week after the end of the treatment
|
FF - T-post
Time Frame: Within a week after the end of the treatment
|
Fat fraction (FF) in the muscular bundles measured from MRI Dixon data acquired at the end of the treatment
|
Within a week after the end of the treatment
|
FA - T-post
Time Frame: Within a week after the end of the treatment
|
Fractional Anisotropy (FA) in the muscular bundles measured from MRI Diffusion data acquired at the end of the treatment
|
Within a week after the end of the treatment
|
MD - T-post
Time Frame: Within a week after the end of the treatment
|
Mean Diffusivity (MD) in the muscular bundles measured from MRI Diffusion data acquired at the end of the treatment
|
Within a week after the end of the treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Denis Peruzzo, PhD, Research Institute IRCCS Eugenio Medea
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIP-745
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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