The Middle East "Stepping Forward" Project (MESF)
MESF
Improving Treatment of People With Movement Disorders in the Middle East
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 5, 2011
CompletedFirst Posted
Study publicly available on registry
November 7, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedNovember 7, 2011
November 1, 2011
6 months
September 5, 2011
November 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
6 Minuets Walk Test (6MinWT)
Mechanical Efficiency
WHOQOL-BREF
Berg Balance Scale (BBS)
Study Arms (3)
Re-Step
EXPERIMENTALMechatronic 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
Dummy shoes
EXPERIMENTALThe shoes are in the same shape and weight of the Re-Step without the perturbations.
treadmill
ACTIVE COMPARATORA treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- Dementia (Mini-Mental Score \< 24)
- Severe aphasia
- Heart failure
- Other medical conditions that preclude participation in low-intensity treadmill walking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assaf Harofeh Medical Center
Ẕerifin, 70300, Israel
Related Publications (1)
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.
PMID: 25113573DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eli Lahat, MD Proffesor
Assaf-Harofeh Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator: Professor Eli Lahat
Study Record Dates
First Submitted
September 5, 2011
First Posted
November 7, 2011
Study Start
October 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2012
Last Updated
November 7, 2011
Record last verified: 2011-11