Clinical trial NCT01466296: The Middle East "Stepping Forward" Project (MESF)
Official title: Improving Treatment of People With Movement Disorders in the Middle East
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cerebral Palsy
Poststroke/CVA Paresis
Keywords: CERBRAL PALSY
Poststroke/CVA Paresis
REHABILITATION
WALKING
PERUTURBATION
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-11-06
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: 10 meter walk test (10MWT)
Secondary outcomes:
measure: 6 Minuets Walk Test (6MinWT)
measure: Mechanical Efficiency
measure: WHOQOL-BREF
measure: Berg Balance Scale (BBS)
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Eli Lahat, MD Proffesor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harries N, Loeppky JA, Shaheen S, Al-Jarrah M, Molteni F, Hutzler Y, Bar-Haim S; MESF Project. A stair-climbing test for measuring mechanical efficiency of ambulation in adults with chronic stroke. Disabil Rehabil. 2015;37(11):1004-8. doi: 10.3109/09638288.2014.948131. Epub 2014 Aug 12.