Status:
UNKNOWN
The Middle East "Stepping Forward" Project (MESF)
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Cerebral Palsy
Poststroke/CVA Paresis
Eligibility:
All Genders
14-69 years
Phase:
PHASE2
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)...
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 s...
Eligibility Criteria
Inclusion
- 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 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01466296
Start Date
October 1 2010
End Date
April 1 2012
Last Update
November 7 2011
Active Locations (1)
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1
Assaf Harofeh Medical Center
Ẕerifin, Israel, 70300