跳至主要内容
临床试验/NCT00940706
NCT00940706Unknown1 期

"Promotion of a Physically Active Lifestyle in Large Populations of Children and Teenagers With Cerebral Palsy in the Middle East"

Assaf-Harofeh Medical Center2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年3月最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
120
试验地点
2
主要终点
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.

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Physical activity in groups

Experimental

Exercises of physical activity

干预措施: Physical activity in groups (Other)

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

干预措施: Monitoring physical activity (Behavioral)

Treadmill

Active Comparator

Treadmill with safety adaptations for handicapped persons

干预措施: TreadMill (Device)

结局指标

主要结局

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.

时间窗: stage I - 15 months stage II - 27 months

次要结局

  • 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)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fany Tusia

Proffesor Eli Lahat Primary Investigator

Assaf-Harofeh Medical Center

研究点 (2)

Loading locations...

相似试验

Promotion of a Physically Active Lifestyle in... | 临床试验