The Effectiveness of Robotic Gait Training in Children With Neurological Impairment

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: Cerebral Palsy; Acquired Brain Injury
• Intervention / Treatment: Device: Robotic Assisted Gait Training (Lokomat); Procedure: Physiotherapy

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

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: Gait Rehabilitation; Robotic-Assisted Gait Training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Brain Damage, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Cerebral Palsy; Brain Injuries
• 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