Cerebral Palsy (CP)Phase 1NCT00940706
Promotion of a Physically Active Lifestyle in Cerebral Palsy
A Phase 1 study testing TreadMill, Physical activity in groups and Monitoring physical activity in people with Cerebral Palsy (CP), run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- TreadMill, Physical activity in groups and Monitoring physical activity
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Promotion of a Physically Active Lifestyle in Large Populations of Children and Teenagers With Cerebral Palsy in the Middle East"
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:
- 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.
- 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.
- 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.
- 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.
Read the detailed description
Stage I: Design A cross sectional research design.
Study participants for stage I: A total of 400 teenagers with CP will be monitored in this stage. All partners of this project will obtain approval for experiments on human subjects from their local committees. Each subject (or parents/guardians for the participation of minor subjects) will be able to sign an informed voluntary consent form, consistent with the Helsinki Declaration, after reading a detailed explanation and having an oral Q/A session with the investigator.
Recruitment: Prospective focused direct mailing or personal contacts will be initiated with the parents/guardians of children with CP who are ambulatory. Subsequent screening will be done by phone interview.
Participants at each center/country. 100 teenagers with CP, age 14-20 yr (50 age 14-17 yr and 50 age 18-20 yr). GMFCS levels II; III and IV.
Measurements:
Stage I:
The ActivePal accelerometer is a research instrument for long-term assessment of ambulatory activity during day-to-day life. Baseline functional status will be measured before interventions, including a completion of a socio-economical questionnaire.
Stage II: Randomized control trial of three training programs to improve the physical activity level and comparison between low and high costs interventions.
Study participants for Stage II. Thirty teenagers with CP at each center (total number of 120 at the four centers) will be matched according to age and GMFCS level (II and III) and randomly assign to one of three treatment programs. Subjects will be recruited from those in the first stage of the project. All partners of this project will obtain approval from their local committees. Each subject (or parents/guardians for the participation of a minor subject) will sign an informed voluntary consent form, consistent with the Helsinki Declaration, after reading a detailed explanation letter and having an oral Q/A session with the investigator.
Measurements:
2-Treadmill training measures will include total training time, step length, and with the split treadmill the velocity gap will also be recorded during each session 3-The gross motor function measure (GMFM) with dimensions D and E (standing, walking, running, jumping) will be used 4-Mechanical efficiency will be measured by the stair-climbing test.
Statistical analysis:
Repeated measures analysis of variance (ANOVA) will be used to determine the effects and compare the three treatment methods. The repeated measures factor will be the pre-post measurements and the grouping factors will be the functional levels (GMFCS) and treatment methods. Differences between pre-post measurements among the three methods will also be tested by one-way ANOVA. A p-value of < 0.05 will be considered significant.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- TreadMill, Physical activity in groups, Monitoring physical activity
- Keywords
- Cerebral Palsy, Activity monitoring, Treadmill, Group training, Physical active life style
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreadMillDevice
Also called TreadMill active focus physical training program
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.
Physical activity in groupsOther
Also called Motor activity
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.
Monitoring physical activityBehavioural
Also called Physical activity monitoring
Activity monitoring with accelerometers
| Study group | Role | What they receive |
|---|---|---|
| Physical activity in groups | Experimental | Exercises of physical activity Receives: Other: Physical activity in groups |
| Activity monitoring with accelerometers | Experimental | Each subject will wear the accelerometer 24 hours a day for 4 days The activity will be recorded and analyzed Receives: Behavioral: Monitoring physical activity |
| Treadmill | Active comparator | Treadmill with safety adaptations for handicapped persons Receives: Device: TreadMill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: before; after; 6 month after the comletion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startMar 2010
- Primary completionApr 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Principal investigator, Fany Tusia, Assaf-Harofeh Medical Center
- Investigators
- Simona Bar-Haim, PhD, Study director, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940706
- Sponsor's protocol ID
- 481987103/09
- Other IDs
- MERC M29-023
- Status last verified
- Jul 2009
- First submitted
- 15 Jul 2009
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30922152Shkedy 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.
PubMed 24506509
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Promotion of a Physically Active Lifestyle in Large Populations of Children and Teenagers With Cerebral Palsy in the Middle East"
- ClinicalTrials.gov ID
- NCT00940706
- Acronym / sponsor ID
- 481987103/09
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Cerebral Palsy, Activity monitoring, Treadmill, Group training, Physical active life style
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Mar 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 16 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
Detailed description
Stage I: Design A cross sectional research design.
Study participants for stage I: A total of 400 teenagers with CP will be monitored in this stage. All partners of this project will obtain approval for experiments on human subjects from their local committees. Each subject (or parents/guardians for the participation of minor subjects) will be able to sign an informed voluntary consent form, consistent with the Helsinki Declaration, after reading a detailed explanation and having an oral Q/A session with the investigator.
Recruitment: Prospective focused direct mailing or personal contacts will be initiated with the parents/guardians of children with CP who are ambulatory. Subsequent screening will be done by phone interview.
Participants at each center/country. 100 teenagers with CP, age 14-20 yr (50 age 14-17 yr and 50 age 18-20 yr). GMFCS levels II; III and IV.
Measurements:
Stage I:
The ActivePal accelerometer is a research instrument for long-term assessment of ambulatory activity during day-to-day life. Baseline functional status will be measured before interventions, including a completion of a socio-economical questionnaire.
Stage II: Randomized control trial of three training programs to improve the physical activity level and comparison between low and high costs interventions.
Study participants for Stage II. Thirty teenagers with CP at each center (total number of 120 at the four centers) will be matched according to age and GMFCS level (II and III) and randomly assign to one of three treatment programs. Subjects will be recruited from those in the first stage of the project. All partners of this project will obtain approval from their local committees. Each subject (or parents/guardians for the participation of a minor subject) will sign an informed voluntary consent form, consistent with the Helsinki Declaration, after reading a detailed explanation letter and having an oral Q/A session with the investigator.
Measurements:
2-Treadmill training measures will include total training time, step length, and with the split treadmill the velocity gap will also be recorded during each session 3-The gross motor function measure (GMFM) with dimensions D and E (standing, walking, running, jumping) will be used 4-Mechanical efficiency will be measured by the stair-climbing test.
Statistical analysis:
Repeated measures analysis of variance (ANOVA) will be used to determine the effects and compare the three treatment methods. The repeated measures factor will be the pre-post measurements and the grouping factors will be the functional levels (GMFCS) and treatment methods. Differences between pre-post measurements among the three methods will also be tested by one-way ANOVA. A p-value of < 0.05 will be considered significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical activity in groups | Experimental | Other: Physical activity in groupsExercises of physical activity |
| Activity monitoring with accelerometers | Experimental | Behavioral: Monitoring physical activityEach subject will wear the accelerometer 24 hours a day for 4 days The activity will be recorded and analyzed |
| Treadmill | Active comparator | Device: TreadMillTreadmill with safety adaptations for handicapped persons |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreadMillAlso: TreadMill active focus physical training programEach 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. | Device | Treadmill |
| Physical activity in groupsAlso: Motor activityEach 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. | Other | Physical activity in groups |
| Monitoring physical activityAlso: Physical activity monitoringActivity monitoring with accelerometers | Behavioural | Activity monitoring with accelerometers |
Primary outcome
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.
Time frame: stage I - 15 months stage II - 27 months
1 secondary outcome
The gross motor function measure (GMFM) with dimensions D and E (standing, walking, running, jumping) will be used.
Time frame: before; after; 6 month after the comletion of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2011.
- Derived from this study: PubMed 30922152Bar-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.
- Derived from this study: PubMed 24506509Shkedy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simona Bar-Haim, PhD study director
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TreadMill, Physical activity in groups and Monitoring physical activity in people with Cerebral Palsy (CP), run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: stage I - 15 months stage II - 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00940706, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2011; AzTrials last refreshed its copy on 26 Oct 2026.