VIRTUAL REALITY TECHNOLOGY FOR UPPER EXTREMITY REHABILITATION OF CHILDREN WITH UNILATERAL CEREBRAL PALSY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- rang of motion
研究概览
简要总结
The VRapeutic (Full-immersive game-based therapy) is new therapeutic Egyptian software. It has the potential to provide intensive, repetitive, and task-oriented training. It may increase children's motivation, enjoyment, active social participation. Children with UCP may experience varieties of associated health conditions as difficulty of movement, instability of postural balance, difficulty of motor planning and control which impact on UE function.
详细描述
Ethical statement this study was approved by institutional Review Board of the faculty of physical therapy ,cairo university .Egypt (no.P.T.REC/012/004237) .
Study Design A prospective randomized controlled trial of pre-post study design with two months follow-up evaluation will be used.
Sample size estimation
will be conducted to determine the number of recruited children. G*POWER statistical software (version 3.1.9.2) will be used using α=0.05, power 80% allocation ratio N2/N1 =1.
Randomization The selected children will be assigned by simple randomization via closed envelopes into two equal groups (control and study); the envelope will be contained a letter indicating whether the child will be assigned to the control or to the study group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
A prospective randomized controlled trial of pre-post study design with two months follow-up evaluation will be used.
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Their ages will range from of 6 to 10 years.
- •Both genders will be included.
- •Their degree of spasticity will range from 1 to 1+ according to the Modified Ashworth Scale (Meseguer et al., 2018).
- •Their motor function will be at level I according to Gross Motor Function Classification System (Palisano et al., 2008).
- •They will be able to understand and follow the instructions.
排除标准
- •Exclusion Criteria:
- •Children will be excluded from the study if they have any of the following criteria:
- •Epilepsy.
- •Visual or hearing problems.
- •Musculoskeletal fixed deformity in upper limbs, lower limbs or spine.
- •Orthopedic surgery on the involved UE.
- •Botulinum toxin therapy for the affected UE within the past 6 months or within the study period.
结局指标
主要结局
rang of motion
时间窗: period of treatment will be 2 succssive months
The IMU sensors will be used to detect changes in angular displacement of child arm, forearm (which allow 3D analysis of movements in three planes X.Y.Z), speed and direction. Placement of Sensors: Two sensors will be placed on the affected side, one around the arm distal to shoulder joint and the other around the forearm distal to elbow joint. The third sensor will be placed around the trunk. The child will be in standing position with head in neutral position, trunk erect. The examiner will ask the child to perform functional task in form of (reaching forward toward targets placed on wall in multilevel, hand over head).
• ABILHAND-Kids questionnaire
时间窗: period of treatment will be 2 succssive months
will be administrated on an interview basis, the child will be asked to estimate their perception of the level of difficulty that faces during the performance of each activity in the list on a three-point ordinal scale of impossible, difficult, easy. Activities will be presented in random order to avoid any systematic effect. Activities not attempted in the last 3 months are not scored and are entered as missing responses (tick the question mark).
次要结局
未报告次要终点
研究者
Amira Mahmoud Abd-elmonem
principle investigator
Cairo University