The Middle East "Stepping Forward" Project (MESF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Fany Tusia, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01466296
First received: September 5, 2011
Last updated: November 3, 2011
Last verified: November 2011

September 5, 2011
November 3, 2011
October 2010
April 2011   (final data collection date for primary outcome measure)
10 meter walk test (10MWT) [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01466296 on ClinicalTrials.gov Archive Site
  • 6 Minuets Walk Test (6MinWT) [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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) [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
The Middle East "Stepping Forward" Project (MESF)
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Cerebral Palsy
  • Poststroke/CVA Paresis
  • Device: 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.
    Other Name: Re-Step shoes
  • Device: 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.
    Other Name: Dummy Shoes
  • Device: 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.
    Other Name: Treadmill
  • Experimental: 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

    Intervention: Device: Chaotic Perturbation
  • Experimental: Dummy shoes
    The shoes are in the same shape and weight of the Re-Step without the perturbations.
    Intervention: Device: Dummy not active shoes
  • Active Comparator: treadmill
    A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills.
    Intervention: Device: Treadmill training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
April 2012
April 2011   (final data collection date for primary outcome measure)

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
Both
14 Years to 69 Years
No
Contact: Simona Bar-Haim, PhD +972 8 9778280 adi-star@013.net
Contact: Netta Harries, BPT +972 8 9778280 netaa@asaf.health.gov.il
Israel
 
NCT01466296
HT 5283 152/09, Yad Hanadiv 5106
Yes
Fany Tusia, Assaf-Harofeh Medical Center
Assaf-Harofeh Medical Center
Not Provided
Principal Investigator: Eli Lahat, MD Proffesor Assaf-Harofeh Medical Center
Assaf-Harofeh Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP