The Middle East "Stepping Forward" Project (MESF)

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Unknown; Phase 2

Conditions: Cerebral Palsy; Poststroke/CVA Paresis

Treatments: Device: Dummy not active shoes; Device: Treadmill training; Device: Chaotic Perturbation

Study type: Interventional

Funder types: Other

Identifiers

NCT01466296

HT 5283 152/09

Yad Hanadiv 5106 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 14 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion criteria for CP group:

1. Diagnosis of cerebral palsy
2. Predominantly spastic type of CP with distribution of diplegia / tetraplegia
3. Age: 14 - 20 yr
4. GMFCS (gross motor function classification system) at levels II & III
5. A cognitive level sufficient to comprehend and cooperate in treatment and testing
6. No orthopedic surgery or other tone reduction intervention in last 6 months
7. Not a candidate for orthopedic surgical or other tone reduction intervention.

Exclusion criteria for CP group:

1. Candidates for orthopedic surgical or any other tone reduction procedures, e.g., botulin injections, baclofen pump interventions
2. Cannot cooperate in treatment or understand instructions
3. Uncontrolled convulsions if epileptic
4. Adolescents with progressive degenerative conditions of CNS or/and muscle-skeletal system.

Inclusion Criteria:

Inclusion criteria for HP group:

1. Stroke survivors in chronic stage (1 year or more following stroke
2. Age: 40 - 65 yr
3. Mild to moderate gait with ability to ambulate > 10m with or without assistive device
4. Cognitive level sufficient to comprehend and cooperate in tests and training
5. Mini-mental state examination (MMSE) score > 24 6: Receive medical clearance from their family physician.

Exclusion criteria

Exclusion criteria for HP group:

1. Dementia (Mini-Mental Score < 24)
2. Severe aphasia
3. Heart failure
4. Other medical conditions that preclude participation in low-intensity treadmill walking

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Re-Step

Experimental group

Description:

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

Treatment:

Device: Chaotic Perturbation

Dummy shoes

Experimental group

Description:

The shoes are in the same shape and weight of the Re-Step without the perturbations.

Treatment:

Device: Dummy not active shoes

treadmill

Active Comparator group

Description:

A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills.

Treatment:

Device: Treadmill training