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Completed

NCT Number: NCT03828110

The Effectiveness of Robotic Gait Training in Children With Neurological Impairment

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).

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Key information

Conditions

Acquired Brain Injury Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Cerebral Palsy Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Scientific Institute IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic Assisted Gait Training (Lokomat)

Device

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

physiotherapy

Procedure

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2019
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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