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The Effectiveness of Robotic Gait Training in Children With Neurological Impairment

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ClinicalTrials.gov Identifier: NCT03828110
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Emilia Biffi, IRCCS Eugenio Medea

Brief 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). 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).

Condition or disease Intervention/treatment
Acquired Brain Injury Cerebral Palsy Device: Robotic Assisted Gait Training (Lokomat) Procedure: Physiotherapy

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Children with neurological impairment Device: Robotic Assisted Gait Training (Lokomat)
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.
Other Name: RAGT

Procedure: Physiotherapy
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. change in spatiotemporal gait parameters [ Time Frame: After four weeks of treatment ]
    Data obtained using 3D gait analysis

  2. change in kinematic gait parameters [ Time Frame: After four weeks of treatment ]
    Data obtained using 3D gait analysis

  3. change in kinetic gait parameters [ Time Frame: After four weeks of treatment ]
    Data obtained using 3D gait analysis

  4. change in FAQ score [ Time Frame: After four weeks of treatment ]
    The Functional Activities Questionnaire (FAQ) measures instrumental activities of daily living

  5. Lokomat therapy duration [ Time Frame: After four weeks of treatment ]
    Total duration of therapy sessions (hours and minutes)

  6. Lokomat therapy total distance walked [ Time Frame: After four weeks of treatment ]
    Total distance walked during sessions (in meters)

  7. Lokomat therapy total time walked [ Time Frame: After four weeks of treatment ]
    Total time walked during sessions

  8. Lokomat stiffness values (LStiff) [ Time Frame: After four weeks of treatment ]
    Joint stiffness measured by the Lokomat device (in Newton/meters)

  9. Lokomat force values (LForce) [ Time Frame: After four weeks of treatment ]
    Joint force measured by the Lokomat device (in Newton)



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neurophysiatric care unit
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828110


Locations
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Italy
Scientific Institute IRCCS E. Medea
Bosisio Parini, Lecco, Italy, 23842
Sponsors and Collaborators
IRCCS Eugenio Medea
Investigators
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Principal Investigator: Emilia Biffi, PhD Scientific Institute IRCCS "E. Medea"

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Responsible Party: Emilia Biffi, Post doc research fellow, IRCCS Eugenio Medea
ClinicalTrials.gov Identifier: NCT03828110     History of Changes
Other Study ID Numbers: GIP-454
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emilia Biffi, IRCCS Eugenio Medea:
Robotic-Assisted Gait Training
Gait Rehabilitation
Additional relevant MeSH terms:
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Brain Injuries
Cerebral Palsy
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic