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

Primary Purpose

Cerebral Palsy, Poststroke/CVA Paresis

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Chaotic Perturbation
Dummy not active shoes
Treadmill training
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring CERBRAL PALSY, Poststroke/CVA Paresis, REHABILITATION, WALKING, PERUTURBATION

Eligibility Criteria

14 Years - 69 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assaf Harofeh Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Re-Step

Dummy shoes

treadmill

Arm Description

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

The shoes are in the same shape and weight of the Re-Step without the perturbations.

A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 5, 2011
Last Updated
November 3, 2011
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01466296
Brief Title
The Middle East "Stepping Forward" Project (MESF)
Acronym
MESF
Official Title
Improving Treatment of People With Movement Disorders in the Middle East
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Poststroke/CVA Paresis
Keywords
CERBRAL PALSY, Poststroke/CVA Paresis, REHABILITATION, WALKING, PERUTURBATION

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Re-Step
Arm Type
Experimental
Arm Description
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
Arm Title
Dummy shoes
Arm Type
Experimental
Arm Description
The shoes are in the same shape and weight of the Re-Step without the perturbations.
Arm Title
treadmill
Arm Type
Active Comparator
Arm Description
A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills.
Intervention Type
Device
Intervention Name(s)
Chaotic Perturbation
Other Intervention Name(s)
Re-Step shoes
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Dummy not active shoes
Other Intervention Name(s)
Dummy Shoes
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Treadmill training
Other Intervention Name(s)
Treadmill
Intervention Description
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.
Primary Outcome Measure Information:
Title
10 meter walk test (10MWT)
Description
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 Measure Information:
Title
6 Minuets Walk Test (6MinWT)
Description
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.
Title
Mechanical Efficiency
Description
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.
Title
WHOQOL-BREF
Description
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.
Title
Berg Balance Scale (BBS)
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simona Bar-Haim, PhD
Phone
+972 8 9778280
Email
adi-star@013.net
First Name & Middle Initial & Last Name or Official Title & Degree
Netta Harries, BPT
Phone
+972 8 9778280
Email
netaa@asaf.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli Lahat, MD Proffesor
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simona Bar-Haim, PhD
Phone
+972 8 9778280
Email
adi-star@013.net
First Name & Middle Initial & Last Name & Degree
Netta Harries, BPT
Phone
+972 8 9778280
Email
netaa@asaf.health.gov.il
First Name & Middle Initial & Last Name & Degree
Mark Belokopytov, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25113573
Citation
Harries N, Loeppky JA, Shaheen S, Al-Jarrah M, Molteni F, Hutzler Y, Bar-Haim S; MESF Project. A stair-climbing test for measuring mechanical efficiency of ambulation in adults with chronic stroke. Disabil Rehabil. 2015;37(11):1004-8. doi: 10.3109/09638288.2014.948131. Epub 2014 Aug 12.
Results Reference
derived

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The Middle East "Stepping Forward" Project (MESF)

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