Promotion of a Physically Active Lifestyle in Cerebral Palsy
"Promotion of a Physically Active Lifestyle in Large Populations of Children and Teenagers With Cerebral Palsy in the Middle East"
2 other identifiers
interventional
120
1 country
1
Brief Summary
There is increasing evidence that physical activity during childhood and adolescence has an important impact on health and behavior outcomes. Lack of physical activity is currently a major concern for the total population and especially for children and adolescents. People with disabilities are at risk for the same health problems as the general population. Due to their disabilities, they have a higher risk for developing secondary conditions that may further affect their health and quality of life.The goals of this project are to develop and evaluate new approaches of treatment for children with cerebral palsy (CP) and to develop low cost tests for evaluating motor functions in natural environments. The overall aim is to raise awareness of, and promote, a physically active lifestyle for Middle East teenagers with disabilities due to CP by means of a collaborative Jordanian-Israeli-Palestinian-Moroccan applied research project. Specific objectives include:
- 1.Evaluation of baseline levels of physical activity in large populations of children and teenagers with CP in the communities of the participating countries by long-term monitoring by accelerometers.
- 2.Conducting a randomized clinical trial to compare the efficacy of an "experimental" physical training program with a treadmill training program in two groups. The experimental training program is based on results of recent motor control studies, as well as the "motor learning" approach to facilitate transfer and retention of learned walking activities.
- 3.Disability Advocacy through dissemination of activity focus programs, raising awareness, making use of new technologies and enhancing and developing the skills and training of personnel working with populations with CP.
- 4.Continuing the expansion of collaborative research efforts pertaining to children and teenagers with physical disabilities between Arab countries and Israel through sharing of skills and knowledge by exchange visits, meetings and seminars and joint training, pediatric physiotherapists and physical educators.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2010
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2009
CompletedFirst Posted
Study publicly available on registry
July 16, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedSeptember 28, 2011
July 1, 2009
2.1 years
July 15, 2009
September 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The ActivPal is a research-grade instrument for long-term assessment of ambulatory activity during day-to-day life. The ActivPal is a highly accurate, unobtrusive instrument worn on the ankle.
stage I - 15 months stage II - 27 months
Secondary Outcomes (1)
The gross motor function measure (GMFM) with dimensions D and E (standing, walking, running, jumping) will be used.
before; after; 6 month after the comletion of intervention
Study Arms (3)
Physical activity in groups
EXPERIMENTALExercises of physical activity
Activity monitoring with accelerometers
EXPERIMENTALEach subject will wear the accelerometer 24 hours a day for 4 days The activity will be recorded and analyzed
Treadmill
ACTIVE COMPARATORTreadmill with safety adaptations for handicapped persons
Interventions
Each subject will undergo 36 intervention sessions, 3 times a week, 12 weeks. Each session - up to 45 minutes TreadMill training: During each session the subject will first exercise with basic stretching and muscle strengthening and then walk on the treadmill. According to the subject's rate of improvement, a therapist will determine the rate of increase in the velocity and slope. The treating therapist will make a written report after each session.
Each subject will undergo 36 intervention sessions, 3 times a week, 12 weeks. Each session - up to 45 minutes. Activity Focus Training: this involves performing gross motor activities at exercise stations that involve repetitive, reciprocal and coordinated movements to facilitate strength and endurance conducted by physical therapists and instructing parents or other caregivers to be involved in the program. These activities are performed in a group, having a minimum of 6 children at one time.
Activity monitoring with accelerometers
Eligibility Criteria
You may qualify if:
- Diagnosis of cerebral palsy
- Predominantly spastic type of CP with diplegia / tetraplegia
- Age: 14 - 20 yr
- GMFCS (gross motor function classification system) at levels II and 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.
You may not qualify if:
- Candidates for orthopedic surgical or 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 musculoskeletal system
- Injury of lower extremity (reported fracture, sprain, strain) in the last 6 months
- Orthopedic or neurological surgery in the last 12 months
- Exercise induced asthma, cardiac problems and uncontrolled seizure disorders. Study Protocol. This stage will compare the efficacy of three training programs in increasing physical activity: a group physical activity program, a treadmill program and a split treadmill program.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assaf-Harofeh Medical Centerlead
- Ben-Gurion University of the Negevcollaborator
Study Sites (1)
Assaf Harofeh Medical Center
Ẕerifin, 70300, Israel
Related Publications (2)
Bar-Haim S, Aviram R, Shkedy Rabani A, Amro A, Nammourah I, Al-Jarrah M, Raanan Y, Loeppky JA, Harries N. Effects of Exercise Interventions on Habitual Physical Activity and Sedentary Behavior in Adolescents With Cerebral Palsy. Pediatr Exerc Sci. 2019 Nov 1;31(4):416-424. doi: 10.1123/pes.2018-0254. Epub 2019 Jun 27.
PMID: 30922152DERIVEDShkedy Rabani A, Harries N, Namoora I, Al-Jarrah MD, Karniel A, Bar-Haim S. Duration and patterns of habitual physical activity in adolescents and young adults with cerebral palsy. Dev Med Child Neurol. 2014 Jul;56(7):673-80. doi: 10.1111/dmcn.12394. Epub 2014 Feb 10.
PMID: 24506509DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Simona Bar-Haim, PhD
Assaf-Harofeh Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Proffesor Eli Lahat Primary Investigator
Study Record Dates
First Submitted
July 15, 2009
First Posted
July 16, 2009
Study Start
March 1, 2010
Primary Completion
April 1, 2012
Study Completion
September 1, 2013
Last Updated
September 28, 2011
Record last verified: 2009-07