The Middle East "Stepping Forward" Project (MESF) (MESF)
3 novembre 2011 mis à jour par: Fany Tusia, Assaf-Harofeh Medical Center
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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
120
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Simona Bar-Haim, PhD
- Numéro de téléphone: +972 8 9778280
- E-mail: adi-star@013.net
Sauvegarde des contacts de l'étude
- Nom: Netta Harries, BPT
- Numéro de téléphone: +972 8 9778280
- E-mail: netaa@asaf.health.gov.il
Lieux d'étude
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Zerifin, Israël, 70300
- Recrutement
- Assaf Harofeh Medical Center
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Contact:
- Simona Bar-Haim, PhD
- Numéro de téléphone: +972 8 9778280
- E-mail: adi-star@013.net
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Contact:
- Netta Harries, BPT
- Numéro de téléphone: +972 8 9778280
- E-mail: netaa@asaf.health.gov.il
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Sous-enquêteur:
- Mark Belokopytov, PhD
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
14 ans à 69 ans (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
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:
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 Criteria:
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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 |
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.
Autres noms:
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Expérimental: Dummy shoes
The shoes are in the same shape and weight of the Re-Step without the perturbations.
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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.
Autres noms:
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Comparateur actif: treadmill
A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills.
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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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
|---|---|
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10 meter walk test (10MWT)
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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.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
|---|---|
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6 Minuets Walk Test (6MinWT)
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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.
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Mechanical Efficiency
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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.
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WHOQOL-BREF
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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.
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Berg Balance Scale (BBS)
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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.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Eli Lahat, MD Proffesor, Assaf-Harofeh Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2010
Achèvement primaire (Réel)
1 avril 2011
Achèvement de l'étude (Anticipé)
1 avril 2012
Dates d'inscription aux études
Première soumission
5 septembre 2011
Première soumission répondant aux critères de contrôle qualité
3 novembre 2011
Première publication (Estimation)
6 novembre 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
6 novembre 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 novembre 2011
Dernière vérification
1 novembre 2011
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HT 5283 152/09
- Yad Hanadiv 5106 (Autre subvention/numéro de financement: Yad Hanadiv Foundation; CPIRF)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .