Improving Treatment of People With Movement Disorders in the Middle East
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 10 meter walk test (10MWT)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 69 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for CP group:
- •Diagnosis of cerebral palsy
- •Predominantly spastic type of CP with distribution of diplegia / tetraplegia
- •Age: 14 - 20 yr
- •GMFCS (gross motor function classification system) at levels II & 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.
- •Exclusion criteria for CP group:
- •Candidates for orthopedic surgical or any 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 muscle-skeletal system.
- •Inclusion Criteria:
- •Inclusion criteria for HP group:
- •Stroke survivors in chronic stage (1 year or more following stroke
- •Age: 40 - 65 yr
- •Mild to moderate gait with ability to ambulate > 10m with or without assistive device
- •Cognitive level sufficient to comprehend and cooperate in tests and training
- •Mini-mental state examination (MMSE) score > 24 6: Receive medical clearance from their family physician.
排除标准
- •Exclusion criteria for HP group:
- •Dementia (Mini-Mental Score < 24)
- •Severe aphasia
- •Heart failure
- •Other medical conditions that preclude participation in low-intensity treadmill walking
结局指标
主要结局
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.
次要结局
- 6 Minuets Walk Test (6MinWT)
- Mechanical Efficiency
- WHOQOL-BREF
- Berg Balance Scale (BBS)
研究者
Fany Tusia
Primary Investigator: Professor Eli Lahat
Assaf-Harofeh Medical Center