The Middle East "Stepping Forward" Project (MESF) (MESF)
3 novembre 2011 aggiornato da: 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.
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
120
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Zerifin, Israele, 70300
- Reclutamento
- Assaf Harofeh Medical Center
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Contatto:
- Simona Bar-Haim, PhD
- Numero di telefono: +972 8 9778280
- Email: adi-star@013.net
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Contatto:
- Netta Harries, BPT
- Numero di telefono: +972 8 9778280
- Email: netaa@asaf.health.gov.il
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Sub-investigatore:
- Mark Belokopytov, PhD
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 14 anni a 69 anni (Bambino, Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
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Comparatore attivo: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
|---|---|
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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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
|---|---|
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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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Eli Lahat, MD Proffesor, Assaf-Harofeh Medical Center
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 ottobre 2010
Completamento primario (Effettivo)
1 aprile 2011
Completamento dello studio (Anticipato)
1 aprile 2012
Date di iscrizione allo studio
Primo inviato
5 settembre 2011
Primo inviato che soddisfa i criteri di controllo qualità
3 novembre 2011
Primo Inserito (Stima)
6 novembre 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
6 novembre 2011
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 novembre 2011
Ultimo verificato
1 novembre 2011
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HT 5283 152/09
- Yad Hanadiv 5106 (Altro numero di sovvenzione/finanziamento: Yad Hanadiv Foundation; CPIRF)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .