Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2010-10-31
2012-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Re-Step
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
Chaotic Perturbation
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.
Dummy shoes
The shoes are in the same shape and weight of the Re-Step without the perturbations.
Dummy not active shoes
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.
treadmill
A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills.
Treadmill training
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.
Interventions
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Chaotic Perturbation
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.
Dummy not active shoes
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.
Treadmill training
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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
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.
1. Dementia (Mini-Mental Score \< 24)
2. Severe aphasia
3. Heart failure
4. Other medical conditions that preclude participation in low-intensity treadmill walking
14 Years
69 Years
ALL
No
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Fany Tusia
Primary Investigator: Professor Eli Lahat
Principal Investigators
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Eli Lahat, MD Proffesor
Role: PRINCIPAL_INVESTIGATOR
Assaf-Harofeh Medical Center
Locations
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Assaf Harofeh Medical Center
Ẕerifin, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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Yad Hanadiv 5106
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HT 5283 152/09
Identifier Type: -
Identifier Source: org_study_id