The Effectiveness of Robotic Gait Training in Children With Neurological Impairment

February 25, 2020 updated by: IRCCS Eugenio Medea

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lecco
      • Bosisio Parini, Lecco, Italy, 23842
        • Scientific Institute IRCCS E. Medea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neurophysiatric care unit

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After four weeks of treatment
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.
After four weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in spatiotemporal gait parameters
Time Frame: After four weeks of treatment
Data obtained using 3D gait analysis
After four weeks of treatment
change in kinematic gait parameters
Time Frame: After four weeks of treatment
Data obtained using 3D gait analysis
After four weeks of treatment
change in kinetic gait parameters
Time Frame: After four weeks of treatment
Data obtained using 3D gait analysis
After four weeks of treatment
change in FAQ score
Time Frame: After four weeks of treatment
The Functional Activities Questionnaire (FAQ) measures instrumental activities of daily living
After four weeks of treatment
Lokomat therapy duration
Time Frame: After four weeks of treatment
Total duration of therapy sessions (hours and minutes)
After four weeks of treatment
Lokomat therapy total distance walked
Time Frame: After four weeks of treatment
Total distance walked during sessions (in meters)
After four weeks of treatment
Lokomat therapy total time walked
Time Frame: After four weeks of treatment
Total time walked during sessions
After four weeks of treatment
Lokomat stiffness values (LStiff)
Time Frame: After four weeks of treatment
Joint stiffness measured by the Lokomat device (in Newton/meters)
After four weeks of treatment
Lokomat force values (LForce)
Time Frame: After four weeks of treatment
Joint force measured by the Lokomat device (in Newton)
After four weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Eugenio Medea

Investigators

  • Principal Investigator: Emilia Biffi, PhD, Scientific Institute IRCCS "E. Medea"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

January 25, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIP-454

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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