The Effectiveness of Robotic Gait Training in Children With Neurological Impairment

NCT03828110 | Completed

• 1 other identifier: GIP-454
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Acquired Brain Injury; Cerebral Palsy

Keywords

Robotic-Assisted Gait Training; Gait Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• change in spatiotemporal gait parameters

  After four weeks of treatment

• change in kinematic gait parameters

  After four weeks of treatment

• change in kinetic gait parameters

  After four weeks of treatment

• change in FAQ score

  After four weeks of treatment

• Lokomat therapy duration

  After four weeks of treatment

Study Arms (1)

Children with neurological impairment

Device: Robotic Assisted Gait Training (Lokomat); Procedure: Physiotherapy

Interventions

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.

Also known as: RAGT

Children with neurological impairment

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.

Children with neurological impairment

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Neurophysiatric care unit

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

Scientific Institute IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

Related Publications (1)

• 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.

  PMID: 31562873 DERIVED

MeSH Terms

Conditions

Brain Injuries; Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Emilia Biffi, PhD

  Scientific Institute IRCCS "E. Medea"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 4, 2019
• Study Start: May 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

IT (1)