The Effectiveness of Robotic Gait Training in Children With Neurological Impairment

Completed

• Conditions: Acquired Brain Injury; Cerebral Palsy
• Interventions: Device: Robotic Assisted Gait Training (Lokomat); Procedure: Physiotherapy

• Registration Number: NCT03828110
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with neurological impairment	Physiotherapy	-
Children with neurological impairment	Robotic Assisted Gait Training (Lokomat)	-

Primary Outcome Measures

Name	Time	Method
change in GMFM-88: total score and Dimensions	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.
Change in 6minWT distance walked	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Scientific Institute IRCCS E. Medea; 🇮🇹 Bosisio Parini, Lecco, Italy