Cerebral PalsyPhase 2MESFNCT01466296
The Middle East "Stepping Forward" Project (MESF)
A Phase 2 study testing Chaotic Perturbation, Dummy not active shoes and Treadmill training in people with Cerebral Palsy and Poststroke/CVA Paresis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 69 years
- Conditions the study is for
- Cerebral Palsy, Poststroke/CVA Paresis
- What is being tested?
- Chaotic Perturbation, Dummy not active shoes and Treadmill training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- Not a candidate for orthopedic surgical or other tone reduction intervention.
- 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.
Who cannot join
- 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.
- Dementia (Mini-Mental Score < 24)
- Severe aphasia
- Heart failure
- Other medical conditions that preclude participation in low-intensity treadmill walking
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical Center
Ẕerifin, 70300
Simona Bar-Haim, PhD, +972 8 9778280, adi-star@013.net
Netta Harries, BPT, +972 8 9778280, netaa@asaf.health.gov.il
About this study
Official title: Improving Treatment of People With Movement Disorders in the Middle East
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.
Read the 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:
- 83 Teenagers with cerebral palsy: the CP group
- 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
- Cerebral Palsy, Poststroke/CVA Paresis
- Being tested
- Chaotic Perturbation, Dummy not active shoes, Treadmill training
- Keywords
- CERBRAL PALSY, Poststroke/CVA Paresis, REHABILITATION, WALKING, PERUTURBATION
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chaotic PerturbationDevice
Also called Re-Step 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 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 shoesDevice
Also called Dummy 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 trainingDevice
Also called Treadmill
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.
| Study group | Role | What they receive |
|---|---|---|
| Re-Step | Experimental | 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 Receives: Device: Chaotic Perturbation |
| Dummy shoes | Experimental | The shoes are in the same shape and weight of the Re-Step without the perturbations. Receives: Device: Dummy not active shoes |
| treadmill | Active comparator | A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills. Receives: Device: Treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
The 6-minute walk test (Enright, 2003) will be used to assess walking endurance. Subjects are instructed to cover as much distance as possible while walking around a marked course for 6 minutes. A member of the research staff will closely monitor the subjects.
Mechanical Efficiency
Mechanical efficiency will be measured by the stair-climbing test (SCT) (Bar-Haim, et al. 2004; 2008). Metabolic cost is predicted from heart rate during the external work while stair-climbing and mechanical efficiency is calculated.
WHOQOL-BREF
The WHO's Quality of Life (WHOQoL-BREF) is an international cross-culturally comparable quality of life assessment instrument. It assesses the individual's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
Berg Balance Scale (BBS)
The BBS is a 14-item scale that quantitatively assesses balance and risk for falls in older community-dwelling adults through direct observation of their performance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startOct 2010
- Primary completionApr 2011
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fany Tusia, Assaf-Harofeh Medical Center
- Investigators
- Eli Lahat, MD Proffesor, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466296
- Sponsor's protocol ID
- HT 5283 152/09
- Other IDs
- Yad Hanadiv 5106
- Acronym
- MESF
- Status last verified
- Nov 2011
- First submitted
- 5 Sep 2011
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25113573
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Treatment of People With Movement Disorders in the Middle East
- ClinicalTrials.gov ID
- NCT01466296
- Acronym / sponsor ID
- MESF / HT 5283 152/09
- Conditions
- Cerebral Palsy, Poststroke/CVA Paresis
- Keywords
- CERBRAL PALSY, Poststroke/CVA Paresis, REHABILITATION, WALKING, PERUTURBATION
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Oct 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (estimated)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 83 Teenagers with cerebral palsy: the CP group
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Re-Step | Experimental | Device: Chaotic PerturbationMechatronic 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 | Experimental | Device: Dummy not active shoesThe shoes are in the same shape and weight of the Re-Step without the perturbations. |
| treadmill | Active comparator | Device: Treadmill trainingA treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills. |
Who may qualify
- Ages
- 14 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
- Dementia (Mini-Mental Score < 24)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chaotic PerturbationAlso: Re-Step shoesEach 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. | Device | Re-Step |
| Dummy not active shoesAlso: Dummy ShoesEach 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. | Device | Dummy shoes |
| Treadmill trainingAlso: TreadmillEach 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. | Device | treadmill |
Primary outcome
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.
4 secondary outcomes
6 Minuets Walk Test (6MinWT)
Mechanical Efficiency
WHOQOL-BREF
Berg Balance Scale (BBS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
- Derived from this study: PubMed 25113573Harries 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eli Lahat, MD Proffesor principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chaotic Perturbation, Dummy not active shoes and Treadmill training in people with Cerebral Palsy and Poststroke/CVA Paresis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simona Bar-Haim, PhD (+972 8 9778280, adi-star@013.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meter walk test (10MWT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01466296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2011; AzTrials last refreshed its copy on 27 Oct 2026.