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The Middle East "Stepping Forward" Project (MESF) (MESF)

3 november 2011 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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:

  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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

120

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Israël
      • Zerifin, Israël, 70300
        • Werving
        • Assaf Harofeh Medical Center
        • Contact:
        • Contact:
        • Onderonderzoeker:
          • Mark Belokopytov, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

14 jaar tot 69 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

Inclusion criteria for CP group:

  1. Diagnosis of cerebral palsy
  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.

Exclusion criteria for CP group:

  1. Candidates for orthopedic surgical or any other tone reduction procedures, e.g., botulin injections, baclofen pump interventions
  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.

Inclusion Criteria:

Inclusion criteria for HP group:

  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:

Exclusion criteria for HP group:

  1. Dementia (Mini-Mental Score < 24)
  2. Severe aphasia
  3. Heart failure
  4. Other medical conditions that preclude participation in low-intensity treadmill walking

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Apparaat: 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.
Andere namen:
  • Re-Step shoes
Experimenteel: Dummy shoes
The shoes are in the same shape and weight of the Re-Step without the perturbations.
Apparaat: 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.
Andere namen:
  • Dummy Shoes
Actieve vergelijker: treadmill
A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills.
Apparaat: 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.
Andere namen:
  • Loopband

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Assaf-Harofeh Medical Center

Onderzoekers

  • Hoofdonderzoeker: Eli Lahat, MD Proffesor, Assaf-Harofeh Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2010

Primaire voltooiing (Werkelijk)

1 april 2011

Studie voltooiing (Verwacht)

1 april 2012

Studieregistratiedata

Eerst ingediend

5 september 2011

Eerst ingediend dat voldeed aan de QC-criteria

3 november 2011

Eerst geplaatst (Schatting)

6 november 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

6 november 2011

Laatste update ingediend die voldeed aan QC-criteria

3 november 2011

Laatst geverifieerd

1 november 2011

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HT 5283 152/09
  • Yad Hanadiv 5106 (Ander subsidie-/financieringsnummer: Yad Hanadiv Foundation; CPIRF)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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