The Middle East "Stepping Forward" Project (MESF)

Cerebral Palsy Clinical Trial

— MESF  

Official title:

Improving Treatment of People With Movement Disorders in the Middle East

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01466296
• Other study ID #: HT 5283 152/09
• Secondary ID: Yad Hanadiv 5106
• Status: Recruiting
• Phase: Phase 2
• First received: September 5, 2011
• Last updated: November 3, 2011
• Start date: October 2010
• Est. completion date: April 2012

Study information

• Verified date: November 2011
• Source: Assaf-Harofeh Medical Center
• Contact: Simona Bar-Haim, PhD
• Phone: +972 8 9778280
• Email: adi-star[@]013.net
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthIsrael: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 69 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Paresis
• Poststroke/CVA Paresis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	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.		No
Secondary	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.		No
Secondary	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.		No
Secondary	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.		No