NCT01466296

The Middle East "Stepping Forward" Project (MESF)

Improving Treatment of People With Movement Disorders in the Middle East

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 14 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The overall objective is to improve the functional status of Middle East adolescents with disabilities due to cerebral palsy (CP) and disabilities in adults due to cerebro-vascular stroke (Hemiplegia) by a collaborative Jordanian-Israeli-Palestinian-Moroccan applied research project.

Detailed description

Specific objectives are: To compare the efficacy of two rehabilitation technologies to facilitate neural reorganization, transfer and retention of treatments results to improve walking in real life situations The investigators suggest a new approach of treatment intervention that will induce unexpected changes of underfoot slopes during walking and will force the central nervous system (CNS) to react and solve problems. The investigators also propose that the new approach will have a significantly superior motor function improvement that will be transferred to real environmental settings and be retained for long periods of time. Research methods and materials Subjects: A total of 166 subjects will be studied in two groups of handicapped persons: 1. 83 Teenagers with cerebral palsy: the CP group 2. 83 Subjects with chronic hemiparesis: the HP group Each group will be sub-divided into three secondary groups, having similar age distributions and level of motor function for the two different therapy approaches: * 21 Treadmill exercise training * 21 Training by randomized perturbations wearing the Random Shoe system * 21 Training with dummy shoes without perturbations The time flow protocol: Recruiting subjects according to inclusion/exclusion criteria The subjects will be tested with the following measures (see arms)at * T0 before starting the interventions to form a base line * T1 after 12 weeks of intensive treatments 3 x week 45 min. * T2 6 months after T1, after the treatment was stopped, to check retainment of results of the treatments after a period of normal daily schedule of the subject The treatments will start in a week from T0 The T1 will be performed in a week after the treatment was completed The T2 will be performed 6 months (take or leave 2 weeks) after T1, 6 months after treatment was stopped.

Conditions

• Cerebral Palsy
• Poststroke/CVA Paresis

Interventions

Type	Name	Description
DEVICE	Chaotic Perturbation	Each subject will undergo 36 intervention sessions, 3 times per week over 12 weeks. Each session will last up to 45 minuets, depending on the subject's endurance. During each session the subject will perform basic stretching and muscle strengthening, then wear the random shoes and perform a set of exercises following specific verbal tasks, e.g., "Walk 5 strides forward," or, "Walk to the right side until I ask you to stop." During this stage of walking the device will impose perturbations in the range tolerated by the subject. The therapist will make a written report of each session.
DEVICE	Dummy not active shoes	Each subject will undergo 36 intervention sessions, 3 times per week over 12 weeks. Each session will last up to 45 minuets, depending on the subject's endurance. During each session the subject will perform basic stretching and muscle strengthening, then wear the dummy shoes and perform a set of exercises following specific verbal tasks, e.g., "Walk 5 strides forward," or, "Walk to the right side until I ask you to stop." During this stage of walking the device will not impose perturbations. The therapist will make a written report of each session.
DEVICE	Treadmill training	Each subject will undergo 36 intervention sessions, 3 times per week over 12 weeks. Each session will last up to 45 minuets, depending on the subject's endurance. During each session the subject will exercise basic stretching and muscle strengthening, then walk on the treadmill. A physiotherapist according the subject's rate of improvement will determine the increase in treadmill velocity and slope. The therapist will make a written report after each session.

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-04-01
• Completion: 2012-04-01
• First posted: 2011-11-07
• Last updated: 2011-11-07

Locations

1 site across 1 country: Israel