Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MERC M29-023 | Other Grant/Funding Number | USA AID MERC M29-023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ben-Gurion University of the Negev | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity in groups | Experimental | Exercises of physical activity |
|
| 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 |
|
| Treadmill | Active Comparator | Treadmill with safety adaptations for handicapped persons |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TreadMill | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Stage II
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Simona Bar-Haim, PhD | Assaf-Harofeh Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofeh Medical Center | Ẕerifin | 70300 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30922152 | Derived | 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. | |
| 24506509 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005080 | Exercise Test |
| D015444 | Exercise |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Physical activity in groups | Other | 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 activity | Behavioral | Activity monitoring with accelerometers |
|
|
| Shkedy 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. |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D003710 | Demography |
| D011154 | Population Characteristics |