The Effectiveness of Robotic Gait Training in Children With Neurological Impairment

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03828110
• Other study ID #: GIP-454
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: February 2020
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Cerebral Palsy

Intervention

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.

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.

Locations

Country	Name	City	State
Italy	Scientific Institute IRCCS E. Medea	Bosisio Parini	Lecco

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

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