The Middle East "Stepping Forward" Project (MESF) — MESF  

Cerebral Palsy Clinical Trial

Official title: Improving Treatment of People With Movement Disorders in the Middle East

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Paresis
• Poststroke/CVA Paresis

• NCT number: NCT01466296
• Study type: Interventional
• Source: Assaf-Harofeh Medical Center
• Contact: Simona Bar-Haim, PhD
• Phone: +972 8 9778280
• Email: adi-star@013.net
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2010
• Completion date: April 2012