The Effectiveness of Robotic Gait Training in Children With Neurological Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Acquired Brain Injury Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Children with neurological impairment

Robotic Assisted Gait Training (Lokomat)

Intervention Type 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.

Physiotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Other Intervention Names

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RAGT

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No