Effects of Electromechanical Gait Trainer in Patients With Cerebral Palsy

NCT01564433 | Completed Early Phase 1 DMC

• 1 other identifier: PCI-GT-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

robotics; rehabilitation; gait; cerebral palsy

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Ten Meter Walking Test

  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

• Wee FIM

  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

• Spatio-temporal gait analysis

  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

Study Arms (2)

Gait trainer treatment

EXPERIMENTAL

Procedure: Device: Electromechanical gait trainer

Conventional group

ACTIVE COMPARATOR

Procedure: Convetional control treatment

Interventions

Device: Electromechanical gait trainer PROCEDURE

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.

Gait trainer treatment

Convetional control treatment PROCEDURE

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.

Conventional group

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• bilateral lower limb (diplegic or tetraplegic) Cerebral Palsy
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

S.S.O. di Riabilitazione dell'Ospedale Policlinico

Verona, 37124, Italy

Location

Related Publications (5)

• 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.

  PMID: 20298820 BACKGROUND

• 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.

  PMID: 20138788 BACKGROUND

• 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.

  PMID: 19874075 BACKGROUND

• 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.

  PMID: 19265768 BACKGROUND

• Foley A, Horwood J, Hall R. Language for change. Aust Fam Physician. 1980 Jun;9(6):416-22. No abstract available.

  PMID: 7213237 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Antonio Fiaschi, Professor

  Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Smania Nicola

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 27, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

IT (1)