The Middle East "Stepping Forward" Project (MESF) (MESF)
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|ClinicalTrials.gov Identifier: NCT01466296|
Recruitment Status : Unknown
Verified November 2011 by Fany Tusia, Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : November 7, 2011
Last Update Posted : November 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy Poststroke/CVA Paresis||Device: Chaotic Perturbation Device: Dummy not active shoes Device: Treadmill training||Phase 2|
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
A total of 166 subjects will be studied in two groups of handicapped persons:
- 83 Teenagers with cerebral palsy: the CP group
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Treatment of People With Movement Disorders in the Middle East|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||April 2012|
Mechatronic shoe with a sole made to change slopes in the swing phase of walking.
This unpredictable change will introduce a situation of necessary adaptation to keep balance
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.
Other Name: Re-Step shoes
Experimental: Dummy shoes
The shoes are in the same shape and weight of the Re-Step without the perturbations.
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.
Other Name: Dummy Shoes
Active Comparator: treadmill
A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills.
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.
Other Name: Treadmill
- 10 meter walk test (10MWT)10-meter walk test (Rossier & Wade, 2001) will assess normal walking speed. The participant walks a straight path distance of 10 meters at normal walking speed with time recorded. The test will be performed twice with the number of steps counted. The tester or an assistant remains near the participant to prevent a fall or injury if they appear unsteady.
- 6 Minuets Walk Test (6MinWT)The 6-minute walk test (Enright, 2003) will be used to assess walking endurance. Subjects are instructed to cover as much distance as possible while walking around a marked course for 6 minutes. A member of the research staff will closely monitor the subjects.
- Mechanical EfficiencyMechanical efficiency will be measured by the stair-climbing test (SCT) (Bar-Haim, et al. 2004; 2008). Metabolic cost is predicted from heart rate during the external work while stair-climbing and mechanical efficiency is calculated.
- WHOQOL-BREFThe WHO's Quality of Life (WHOQoL-BREF) is an international cross-culturally comparable quality of life assessment instrument. It assesses the individual's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
- Berg Balance Scale (BBS)The BBS is a 14-item scale that quantitatively assesses balance and risk for falls in older community-dwelling adults through direct observation of their performance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466296
|Contact: Simona Bar-Haim, PhD||+972 8 firstname.lastname@example.org|
|Contact: Netta Harries, BPT||+972 8 email@example.com|
|Assaf Harofeh Medical Center||Recruiting|
|Zerifin, Israel, 70300|
|Contact: Simona Bar-Haim, PhD +972 8 9778280 firstname.lastname@example.org|
|Contact: Netta Harries, BPT +972 8 9778280 email@example.com|
|Sub-Investigator: Mark Belokopytov, PhD|
|Principal Investigator:||Eli Lahat, MD Proffesor||Assaf-Harofeh Medical Center|