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Effects of Electromechanical Gait Trainer in Patients With Cerebral Palsy

NCT01564433 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-06-14

No results posted yet for this study

Summary

Cerebral Palsy (CP) describes a group of chronic conditions affecting body movement and muscle coordination caused by damage to one or more areas of the brain, usually occurring during fetal development or infancy. One of the most disabling mobility impairments in CP is gait impairment, clinically characterized by reduced speed and endurance, as well as reduced step, stride length and toe clearance during gait.

Recently, gait rehabilitation methods in patients with neurological impairment have relied on technological devices, which drive the patient's gait in a body-weight support condition and emphasize the beneficial role of repetitive practice. Early studies in gait rehabilitation in patients with CP were carried out by using partial body-weight support treadmill training (PBWSTT) and robotic-assisted treadmill therapy. Despite their potential, these technologies have practical limitations in their routine application.

More recently, several studies have focused on the use of a new electromechanical gait trainer (Gait Trainer GT I; Reha-Stim, Berlin, Germany) in adult patients who have experienced a stroke. They have shown that training with this device may significantly improve gait performance. Despite the clinical impact of this new rehabilitative procedure, to date, no studies have been conducted on its use in children with CP.

Conditions

  • Cerebral Palsy

Interventions

PROCEDURE

Device: Electromechanical gait trainer

The experimental group will be subjected to 12-30 minute session (3 per week: Monday, Wednesday, Friday) of repetitive locomotor therapy on the Gait Trainer (Reha-Stim, Berlin, Germany), followed by 20 minutes of passive joint mobilization and stretching exercises. The GT-I consists of a double crank and rocker gear system, composed of two footplates positioned on two bars (coupler), two rockers, and two cranks that provide the propulsion. While using the gait trainer, individuals are secured in a harness and positioned on two footplates, whose movements simulate stance and swing phase, with a ratio of 60% to 40% between the two phases. The body weight was initially reduced by 30% and then progressively increased.

PROCEDURE

Convetional control treatment

The control group will be subjected to a conventional treatment that will consist of three different sets of exercises: 1) passive joint mobilization and stretching of lower limb muscles; 2) muscle strengthening exercises; 3) gait exercises. Each set of exercises lasted 10, 15 and 15 min, respectively with 2,5 min at rest between each set for a total of 40 minutes.

Sponsors & Collaborators

  • Universita di Verona

    lead OTHER

Principal Investigators

  • Antonio Fiaschi, Professor · Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2011-12-31
Completion
2012-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01564433 on ClinicalTrials.gov