Acquired Brain InjuryNCT03828110
The Effectiveness of Robotic Gait Training in Children With Neurological Impairment
An observational study of Acquired Brain Injury and Cerebral Palsy, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
The recovery of walking ability is one of the primary rehabilitation goals for children with neurological impairment. The aim of the study is to investigate the clinical effectiveness of rehabilitation treatments based of Robotic-Assisted Gait Training (RAGT). Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Acquired Brain Injury, Cerebral Palsy
- What is being tested?
- Robotic Assisted Gait Training (Lokomat) and Physiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2017to 30 Apr 2019
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Neurophysiatric care unit
Who may be able to join
- Diagnosis of acquired brain injury in pediatric age and adolescence (4 to 18 years) or cerebral palsy;
- Femur length of at least 23 cm;
- Patients able to signal pain, fear or discomfort reliably and to follow simple instructions.
Who cannot join
- injection of botulinum toxin during the 6 months prior to the enrollment;
- oral medications reducing muscle tone;
- previous orthopedic surgery;
- severe lower-extremity contractures;
- fractures or osseous instabilities;
- osteoporosis;
Show all 13Show fewer
- contraindication of full body load due to previous surgeries;
- severe retarded bone growth;
- unhealed skin lesions in the lower-extremities;
- thromboembolic diseases
- cardiovascular instability
- acute or progressive neurological disorders
- aggressive or self-harming behavior.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effectiveness of Robotic-Assisted Gait Training (RAGT) in the Rehabilitation of Children With Neurological Impairment Due to Acquired Brain Injury or Cerebral Palsy
The recovery of walking ability is one of the primary rehabilitation goals for children with neurological impairment. The aim of the study is to investigate the clinical effectiveness of rehabilitation treatments based of Robotic-Assisted Gait Training (RAGT). Additional goals of the research are to identify the specific effects of RAGT in children with different etiologies (acquired brain injury and cerebral palsy) and with different levels of function (according to the Gross Motor Function Classification System).
- Conditions
- Acquired Brain Injury, Cerebral Palsy
- Being tested
- Robotic Assisted Gait Training (Lokomat), Physiotherapy
- Keywords
- Robotic-Assisted Gait Training, Gait Rehabilitation
- Medical subject headings
- Brain Injuries, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted Gait Training (Lokomat)Device
Also called RAGT
The RAGT treatment consisted of sessions lasting 45 minutes each performed with the commercially available Lokomat device. The same exercises were offered to the children with preset duration, speed, and difficulty. For all patients, the initial body-weight support was set at 50%, and was then gradually decreased according to the individual functional capacity. The guidance force was initially set to 100% for all children, and then gradually reduced.
PhysiotherapyProcedure or surgery
The physiotherapic sessions aimed at 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 and climbing stairs.
| Study group | Role | What they receive |
|---|---|---|
| Children with neurological impairment | Not described Receives: Device: Robotic Assisted Gait Training (Lokomat); Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6minWT distance walked
The 6-minute walk test (6minWT) was used to assess endurance during self-paced, submaximal walk by measuring the distance walked within 6 minutes along a standardized route through the hospital corridors.
Measured: After four weeks of treatment
change in GMFM-88: total score and Dimensions
The Gross Motor Function Measure (GMFM) measures the child's overall functional abilities, and is divided into the following sections: (A) lying and rolling, (B) sitting, (C) crawling and kneeling, (D) standing, and (E) walking, running, and jumping.
Measured: After four weeks of treatment
Secondary outcomes (9)
change in spatiotemporal gait parameters
Data obtained using 3D gait analysis
Measured: After four weeks of treatment
change in kinematic gait parameters
Data obtained using 3D gait analysis
Measured: After four weeks of treatment
change in kinetic gait parameters
Data obtained using 3D gait analysis
Measured: After four weeks of treatment
change in FAQ score
The Functional Activities Questionnaire (FAQ) measures instrumental activities of daily living
Measured: After four weeks of treatment
Lokomat therapy duration
Total duration of therapy sessions (hours and minutes)
Measured: After four weeks of treatment
Lokomat therapy total distance walked
Total distance walked during sessions (in meters)
Measured: After four weeks of treatment
Lokomat therapy total time walked
Total time walked during sessions
Measured: After four weeks of treatment
Lokomat stiffness values (LStiff)
Joint stiffness measured by the Lokomat device (in Newton/meters)
Measured: After four weeks of treatment
Lokomat force values (LForce)
Joint force measured by the Lokomat device (in Newton)
Measured: After four weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 May 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilia Biffi, PhD, Principal investigator, Scientific Institute IRCCS "E. Medea"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828110
- Sponsor's protocol ID
- GIP-454
- Status last verified
- Feb 2020
- First submitted
- 25 Jan 2019
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beretta E, Storm FA, Strazzer S, Frascarelli F, Petrarca M, Colazza A, Cordone G, Biffi E, Morganti R, Maghini C, Piccinini L, Reni G, Castelli E. Effect of Robot-Assisted Gait Training in a Large Population of Children With Motor Impairment Due to Cerebral Palsy or Acquired Brain Injury. Arch Phys Med Rehabil. 2020 Jan;101(1):106-112. doi: 10.1016/j.apmr.2019.08.479. Epub 2019 Sep 25.
PubMed 31562873
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Robotic-Assisted Gait Training (RAGT) in the Rehabilitation of Children With Neurological Impairment Due to Acquired Brain Injury or Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03828110
- Acronym / sponsor ID
- GIP-454
- Conditions
- Acquired Brain Injury, Cerebral Palsy
- Keywords
- Robotic-Assisted Gait Training, Gait Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 4 Feb 2019 (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.
The recovery of walking ability is one of the primary rehabilitation goals for children with neurological impairment. The aim of the study is to investigate the clinical effectiveness of rehabilitation treatments based of Robotic-Assisted Gait Training (RAGT). Additional goals of the research are to identify the specific effects of RAGT in children with different etiologies (acquired brain injury and cerebral palsy) and with different levels of function (according to the Gross Motor Function Classification System).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with neurological impairment | – | Device: Robotic Assisted Gait Training (Lokomat), Procedure: Physiotherapy |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Neurophysiatric care unit
Key inclusion criteria (3 listed)
- Diagnosis of acquired brain injury in pediatric age and adolescence (4 to 18 years) or cerebral palsy;
- Femur length of at least 23 cm;
- Patients able to signal pain, fear or discomfort reliably and to follow simple instructions.
Key exclusion criteria (13 listed)
- injection of botulinum toxin during the 6 months prior to the enrollment;
- oral medications reducing muscle tone;
- previous orthopedic surgery;
- severe lower-extremity contractures;
- fractures or osseous instabilities;
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 |
|---|---|---|
| Robotic Assisted Gait Training (Lokomat)Also: RAGTThe RAGT treatment consisted of sessions lasting 45 minutes each performed with the commercially available Lokomat device. The same exercises were offered to the children with preset duration, speed, and difficulty. For all patients, the initial body-weight support was set at 50%, and was then gradually decreased according to the individual functional capacity. The guidance force was initially set to 100% for all children, and then gradually reduced. | Device | Children with neurological impairment |
| PhysiotherapyThe physiotherapic sessions aimed at 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 and climbing stairs. | Procedure or surgery | Children with neurological impairment |
Primary outcome
Change in 6minWT distance walked
Time frame: After four weeks of treatment
The 6-minute walk test (6minWT) was used to assess endurance during self-paced, submaximal walk by measuring the distance walked within 6 minutes along a standardized route through the hospital corridors.
change in GMFM-88: total score and Dimensions
Time frame: After four weeks of treatment
The Gross Motor Function Measure (GMFM) measures the child's overall functional abilities, and is divided into the following sections: (A) lying and rolling, (B) sitting, (C) crawling and kneeling, (D) standing, and (E) walking, running, and jumping.
9 secondary outcomes
change in spatiotemporal gait parameters
Time frame: After four weeks of treatment
change in kinematic gait parameters
Time frame: After four weeks of treatment
change in kinetic gait parameters
Time frame: After four weeks of treatment
change in FAQ score
Time frame: After four weeks of treatment
Lokomat therapy duration
Time frame: After four weeks of treatment
Lokomat therapy total distance walked
Time frame: After four weeks of treatment
Lokomat therapy total time walked
Time frame: After four weeks of treatment
Lokomat stiffness values (LStiff)
Time frame: After four weeks of treatment
Lokomat force values (LForce)
Time frame: After four weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Derived from this study: PubMed 31562873Beretta E, Storm FA, Strazzer S, Frascarelli F, Petrarca M, Colazza A, Cordone G, Biffi E, Morganti R, Maghini C, Piccinini L, Reni G, Castelli E. Effect of Robot-Assisted Gait Training in a Large Population of Children With Motor Impairment Due to Cerebral Palsy or Acquired Brain Injury. Arch Phys Med Rehabil. 2020 Jan;101(1):106-112. doi: 10.1016/j.apmr.2019.08.479. Epub 2019 Sep 25.
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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.
Emilia Biffi, PhD principal investigator
Scientific Institute IRCCS "E. 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 Acquired Brain Injury and Cerebral Palsy, 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 26 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6minWT distance walked (time frame: After four weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03828110, which also lists 1 linked publication.
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 26 Feb 2020.