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

3. november 2011 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Israel
      • Zerifin, Israel, 70300
        • Rekruttering
        • Assaf Harofeh Medical Center
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Mark Belokopytov, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år til 69 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Enhed: 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.
Andre navne:
  • Re-Step shoes
Eksperimentel: Dummy shoes
The shoes are in the same shape and weight of the Re-Step without the perturbations.
Enhed: 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.
Andre navne:
  • Dummy Shoes
Aktiv komparator: treadmill
A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills.
Enhed: 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.
Andre navne:
  • Løbebånd

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assaf-Harofeh Medical Center

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2010

Primær færdiggørelse (Faktiske)

1. april 2011

Studieafslutning (Forventet)

1. april 2012

Datoer for studieregistrering

Først indsendt

5. september 2011

Først indsendt, der opfyldte QC-kriterier

3. november 2011

Først opslået (Skøn)

6. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. november 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2011

Sidst verificeret

1. november 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HT 5283 152/09
  • Yad Hanadiv 5106 (Andet bevillings-/finansieringsnummer: Yad Hanadiv Foundation; CPIRF)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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