Traumatic Brain InjuryNCT04768192
Functional and MRI Evaluation of the Robot-assisted and Traditional Rehabilitation Programs on the Muscle
An observational study of Traumatic Brain Injury, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Physical Rehabilitation without lokomat and Physical Rehabilitation with Lokomat
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Scientific Institute IRCCS Eugenio Medea
Bosisio Parini, LC, 23842
Denis Peruzzo, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Physical Rehabilitation without lokomat, Physical Rehabilitation with Lokomat
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Rehabilitation without lokomatProcedure or surgery
Also called Conventional physiotherapy
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:
- strengthening exercises had to involve all the lower limb joints (no segmental intervention)
- during each session, at least 4 out of the 7 categories above had to be delivered
- the impossibility to perform any of the categories above during any session had to be recorded in the patient's treatment diary.
Physiotherapists of the treatments group discuss patients' diaries during weekly meetings.
Physical Rehabilitation with LokomatProcedure or surgery
Also called Lokomat
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.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients with acquired brain injury | Subjects with a acquired brain injury occurred in the last 10 months prior the beginning of the treatment Receives: Procedure: Physical Rehabilitation without lokomat; Procedure: Physical Rehabilitation with Lokomat |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMFM - T-pre
Gross Motor Function Measures (GMFM) acquired before the beginning of the treatment. (Functional measure)
Measured: The week before the beginning of the treatment
6mwt - T-pre
Six minute walking test (6mwt) performed before the beginning of the treatment. (Functional measure)
Measured: The week before the beginning of the treatment
Ashowrth scale - T-pre
Ashowrth scale acquired before the beginning of the treatment. (Functional measure)
Measured: The week before the beginning of the treatment
Tardieu scale - T-pre
Tardieu scale acquired before the beginning of the treatment. (Functional measure)
Measured: The week before the beginning of the treatment
GMFM - T-post
Gross Motor Function Measures (GMFM) acquired after the end of the treatment. (Functional measure)
Measured: Within a week after the ent of the treatment
6mwt - T-post
Six minute walking test (6mwt) performed after the end of the treatment. (Functional measure)
Measured: Within a week after the ent of the treatment
Ashowrth scale - T-post
Ashowrth scale acquired performed after the end of the treatment. (Functional measure)
Measured: Within a week after the ent of the treatment
Tardieu scale - T-post
Tardieu scale acquired performed after the end of the treatment. (Functional measure)
Measured: Within a week after the ent of the treatment
Secondary outcomes (8)
WF - T-pre
Water fraction (WF) in the muscular bundles measured from MRI Dixon data acquired before the beginning of the treatment
Measured: The week before the beginning of the treatment
FF - T-pre
Fat fraction (FF) in the muscular bundles measured from MRI Dixon data acquired before the beginning of the treatment
Measured: The week before the beginning of the treatment
FA - T-pre
Fractional Anisotropy (FA) in the muscular bundles measured from MRI Diffusion data acquired before the beginning of the treatment
Measured: The week before the beginning of the treatment
MD - T-pre
Mean Diffusivity (MD) in the muscular bundles measured from MRI Diffusion data acquired before the beginning of the treatment
Measured: The week before the beginning of the treatment
WF - T-post
Water fraction (WF) in the muscular bundles measured from MRI Dixon data acquired at the end of the treatment
Measured: Within a week after the end of the treatment
FF - T-post
Fat fraction (FF) in the muscular bundles measured from MRI Dixon data acquired at the end of the treatment
Measured: Within a week after the end of the treatment
FA - T-post
Fractional Anisotropy (FA) in the muscular bundles measured from MRI Diffusion data acquired at the end of the treatment
Measured: Within a week after the end of the treatment
MD - T-post
Mean Diffusivity (MD) in the muscular bundles measured from MRI Diffusion data acquired at the end of the treatment
Measured: Within a week after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Jan 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- The National Research Council, Italy
- Responsible party
- Sponsor
- Investigators
- Denis Peruzzo, PhD, Principal investigator, Research Institute IRCCS Eugenio Medea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768192
- Sponsor's protocol ID
- GIP-745
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and MRI Evaluation of the Robot-assisted and Traditional Rehabilitation Programs on the Muscle in Subjects With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT04768192
- Acronym / sponsor ID
- GIP-745
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- The National Research Council, Italy
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with acquired brain injury | – | Procedure: Physical Rehabilitation without lokomat, Procedure: Physical Rehabilitation with LokomatSubjects with a acquired brain injury occurred in the last 10 months prior the beginning of the treatment |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Rehabilitation without lokomatAlso: Conventional physiotherapyConventional 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: 1. strengthening exercises had to involve all the lower limb joints (no segmental intervention) 2. during each session, at least 4 out of the 7 categories above had to be delivered 3. the impossibility to perform any of the categories above during any session had to be recorded in the patient's treatment diary. Physiotherapists of the treatments group discuss patients' diaries during weekly meetings. | Procedure or surgery | Pediatric patients with acquired brain injury |
| Physical Rehabilitation with LokomatAlso: LokomatThe 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. | Procedure or surgery | Pediatric patients with acquired brain injury |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
8 secondary outcomes
WF - T-pre
Time frame: The week before the beginning of the treatment
FF - T-pre
Time frame: The week before the beginning of the treatment
FA - T-pre
Time frame: The week before the beginning of the treatment
MD - T-pre
Time frame: The week before the beginning of the treatment
WF - T-post
Time frame: Within a week after the end of the treatment
FF - T-post
Time frame: Within a week after the end of the treatment
FA - T-post
Time frame: Within a week after the end of the treatment
MD - T-post
Time frame: Within a week after the end of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Peruzzo, PhD principal investigator
Research Institute IRCCS Eugenio Medea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis Peruzzo, PhD (+39031877939, denis.peruzzo@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GMFM - T-pre (time frame: The week before the beginning of the treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.