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Effects of Electromechanical Gait Trainer in Patients With Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicola Smania, MD, Clinical Professor, Universita di Verona
ClinicalTrials.gov Identifier:
NCT01564433
First received: March 14, 2012
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Cerebral Palsy
Procedure: Device: Electromechanical gait trainer
Procedure: Convetional control treatment
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of an Electromechanical Gait Trainer in Gait Impairments and Endurance in Patients With Cerebral Palsy: a Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Six Minute Walking Test [ Time Frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment. ] [ Designated as safety issue: Yes ]
    The patient will be asked to walk at her/his self-selected walking speed in the gym along during the instrumental test.


Secondary Outcome Measures:
  • Ten Meter Walking Test [ Time Frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU ] [ Designated as safety issue: Yes ]
    This is a validated test for the clinical evalua- tion of walking speed.21 The subject will be asked to walk at her/his self-selected walking speed along the central 10 m of a 14-m linoleum-covered walkway. A digital stopwatch will be used to time the walks.

  • Wee FIM [ Time Frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU ] [ Designated as safety issue: Yes ]
    This widely used scale for the evaluation of disability in children with CP investigates three main domains: self-care, mobility, and cognition (score, 18Y126; high, best performance).

  • Spatio-temporal gait analysis [ Time Frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU ] [ Designated as safety issue: Yes ]
    Spatio-temporal gait analysis will be evaluated by using a computerized system called GAITRite system (Gold, version 3.2 b - CIR Systems, Inc, Havertown, PA). Patients will ask to ambulate along the 7.66m electronic walkway at their fastest speed. The following gait parameters will be considered: gait speed (cm/sec), cadence (step/min), stride length (cm), step length (cm), heel to heel base support (cm), swing of cycle (%), stance of cycle (%), single support of cycle (%) and double support of cycle (%)


Enrollment: 20
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gait trainer treatment 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.
Active Comparator: Conventional group 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.

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  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bilateral lower limb (diplegic or tetraplegic) Cerebral Palsy
  • 10 to 16 years of age
  • GMFCS levels II to IV
  • walk by themselves or with the use of an assistance device for at least 10 meters
  • maintain a sitting position without assistance
  • follow instructions and participate in the rehabilitative program

Exclusion Criteria:

  • lower limb spasticity >2 on the Modified Ashworth Scale
  • severe lower limb contractures
  • cardiovascular diseases
  • orthopedic surgery or neurosurgery in the past 12 months or Botulinum toxin injections within 6 months before the beginning of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564433

Locations
Italy
S.S.O. di Riabilitazione dell'Ospedale Policlinico
Verona, Italy, 37124
Sponsors and Collaborators
Universita di Verona
Investigators
Study Chair: Antonio Fiaschi, Professor Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy
  More Information

Publications:
Responsible Party: Nicola Smania, MD, Clinical Professor, Prof. Smania Nicola, Universita di Verona
ClinicalTrials.gov Identifier: NCT01564433     History of Changes
Other Study ID Numbers: PCI-GT-2
Study First Received: March 14, 2012
Last Updated: June 13, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Universita di Verona:
robotics
rehabilitation
gait
cerebral palsy

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014