The Middle East Stepping Forward Project (MESF)

Study Overview
=================
Brief 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: 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.

Official Title
-----------------
Improving Treatment of People With Movement Disorders in the Middle East

Conditions
-----------------
Cerebral Palsy, Poststroke/CVA Paresis

Intervention / Treatment
-----------------
* Device: Chaotic Perturbation
* Device: Dummy not active shoes
* Device: Treadmill training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria for CP group: Diagnosis of cerebral palsy Predominantly spastic type of CP with distribution of diplegia / tetraplegia Age: 14 - 20 yr GMFCS (gross motor function classification system) at levels II & III A cognitive level sufficient to comprehend and cooperate in treatment and testing No orthopedic surgery or other tone reduction intervention in last 6 months Not a candidate for orthopedic surgical or other tone reduction intervention. Exclusion criteria for CP group: Candidates for orthopedic surgical or any other tone reduction procedures, e.g., botulin injections, baclofen pump interventions Cannot cooperate in treatment or understand instructions Uncontrolled convulsions if epileptic Adolescents with progressive degenerative conditions of CNS or/and muscle-skeletal system. Inclusion Criteria: Inclusion criteria for HP group: Stroke survivors in chronic stage (1 year or more following stroke Age: 40 - 65 yr Mild to moderate gait with ability to ambulate > 10m with or without assistive device Cognitive level sufficient to comprehend and cooperate in tests and training Mini-mental state examination (MMSE) score > 24 6: Receive medical clearance from their family physician. Exclusion Criteria: Exclusion criteria for HP group: Dementia (Mini-Mental Score < 24) Severe aphasia Heart failure Other medical conditions that preclude participation in low-intensity treadmill walking

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Re-Step<br>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<br>* 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.<br>* Other names: Re-Step shoes;|
| Experimental: Dummy shoes<br>The shoes are in the same shape and weight of the Re-Step without the perturbations. | Device: Dummy not active shoes<br>* 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.<br>* Other names: Dummy Shoes;|
| Active Comparator: treadmill<br>A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills. | Device: Treadmill training<br>* 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.<br>* Other names: Treadmill;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Efficiency | Mechanical 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-BREF | The 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. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CERBRAL PALSY, Poststroke/CVA Paresis, REHABILITATION, WALKING, PERUTURBATION