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
  Purpose

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.


Condition Intervention Phase
Cerebral Palsy
Poststroke/CVA Paresis
Device: Chaotic Perturbation
Device: Dummy not active shoes
Device: Treadmill training
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Treatment of People With Movement Disorders in the Middle East

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: October 2010
Estimated Study Completion Date: April 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Experimental: Dummy shoes
The shoes are in the same shape and weight of the Re-Step without the perturbations.
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
Active Comparator: treadmill
A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466296

Contacts
Contact: Simona Bar-Haim, PhD +972 8 9778280 adi-star@013.net
Contact: Netta Harries, BPT +972 8 9778280 netaa@asaf.health.gov.il

Locations
Israel
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Simona Bar-Haim, PhD    +972 8 9778280    adi-star@013.net   
Contact: Netta Harries, BPT    +972 8 9778280    netaa@asaf.health.gov.il   
Sub-Investigator: Mark Belokopytov, PhD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Eli Lahat, MD Proffesor Assaf-Harofeh Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Fany Tusia, Primary Investigator: Professor Eli Lahat, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01466296     History of Changes
Other Study ID Numbers: HT 5283 152/09, Yad Hanadiv 5106
Study First Received: September 5, 2011
Last Updated: November 3, 2011
Health Authority: Israel: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Assaf-Harofeh Medical Center:
CERBRAL PALSY
Poststroke/CVA Paresis
REHABILITATION
WALKING
PERUTURBATION

Additional relevant MeSH terms:
Cerebral Palsy
Paresis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014