Cerebral Palsy Clinical Trial
Official title:
The Effects of an Electromechanical Gait Trainer in Gait Impairments and Endurance in Patients With Cerebral Palsy: a Randomized Control Trial
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 16 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | S.S.O. di Riabilitazione dell'Ospedale Policlinico | Verona |
Lead Sponsor | Collaborator |
---|---|
Universita di Verona |
Italy,
Borggraefe I, Schaefer JS, Klaiber M, Dabrowski E, Ammann-Reiffer C, Knecht B, Berweck S, Heinen F, Meyer-Heim A. Robotic-assisted treadmill therapy improves walking and standing performance in children and adolescents with cerebral palsy. Eur J Paediatr Neurol. 2010 Nov;14(6):496-502. doi: 10.1016/j.ejpn.2010.01.002. Epub 2010 Feb 6. — View Citation
Damiano DL, DeJong SL. A systematic review of the effectiveness of treadmill training and body weight support in pediatric rehabilitation. J Neurol Phys Ther. 2009 Mar;33(1):27-44. doi: 10.1097/NPT.0b013e31819800e2. Review. — View Citation
Foley A, Horwood J, Hall R. Language for change. Aust Fam Physician. 1980 Jun;9(6):416-22. — View Citation
Willoughby KL, Dodd KJ, Shields N, Foley S. Efficacy of partial body weight-supported treadmill training compared with overground walking practice for children with cerebral palsy: a randomized controlled trial. Arch Phys Med Rehabil. 2010 Mar;91(3):333-9. doi: 10.1016/j.apmr.2009.10.029. — View Citation
Willoughby KL, Dodd KJ, Shields N. A systematic review of the effectiveness of treadmill training for children with cerebral palsy. Disabil Rehabil. 2009;31(24):1971-9. doi: 10.3109/09638280902874204. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Six Minute Walking Test | The patient will be asked to walk at her/his self-selected walking speed in the gym along during the instrumental test. | 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. | Yes |
Secondary | Ten Meter Walking Test | 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. | 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 | Yes |
Secondary | Wee FIM | 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). | 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 | Yes |
Secondary | Spatio-temporal gait analysis | 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 (%) | 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 | Yes |
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