NCT05244083Enrolling By Invitation不适用
Effectiveness of the Mirror Therapy for Improving Bimanual Performance, Somatosensory Function of the Impaired Upper Limb and Quality of Life in Children With Unilateral Spastic Cerebral Palsy: A Randomised Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Bimanual Performance
研究概览
简要总结
- Background: Unilateral Spastic Cerebral Palsy (USPC) is caused by an injury in one brain hemisphere in the immature brain, and affects the contralateral side of the body, especially on the upper limb. It induces motor and somatosensory damages, that are closely related to the hand function. Evidence posits mirror therapy to be a therapy with potential effects on bimanual performance and somatosensory function, that may influence on quality of life. The aim of this study is to demonstrate the effectiveness of a motor program with mirror therapy in children with USCP in the improvement of the bimanual performance, the somatosensory function and quality of life compared with the same program without mirror.
- Methods: This study is a Randomised Clinical Trial. The participants are children with USCP aged between 8 and 12 years old classified in levels I and II in Manual Ability Classification System, recruited from Fundació Aspace Catalunya. The eligibility criteria are a) to not have had surgical interventions, botulinum toxin or shock waves 3 months before the study; b) to not be receiving intensive therapies on the upper limb; c) to not have attentional or behavioural difficulties; d) to not have moderate to high intellectual disability; e) to not have non-treated epilepsy; and f) to not have non-corrected visual problems. A total of 22 participants will be recruited for this study, and will be randomised in two groups: control and experimental, through the opaque envelope technique. The experimental group will perform a 5-week motor program consisting of 4 bimanual exercises with mirror therapy, to be done at home 30 minutes a day, 5 days a week, while the control group will perform the same program without the mirror. The assessments will be done by a blinded evaluator and will include bimanual performance (Children's Hand-use Experience Questionnaire), somatosensory function and quality of life (PedsQL™), and will be performed at the beginning, at the end of the intervention and 1-month follow-up.
- Discussion: Favourably results in this study may imply the implementation of a low-cost therapy, suitable to be done at home, and with no contraindications for children with USCP. Moreover, the suitability to be adapted and performed at home could increase the family implication and empowerment, increasing its confidence in the disability process.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To have been diagnosed with Unilateral Spastic Cerebral Palsy.
- •To be capable of following and understanding rules.
排除标准
- •To have had surgical interventions, botulinum toxin or shock waves 3 months before the study;
- •To be receiving intensive therapies on the upper limb;
- •To have attentional or behavioural difficulties;
- •To have moderate to high intellectual disability;
- •To have non-treated epilepsy;
- •To have non-corrected visual problems
研究组 & 干预措施
Experimental Group
Experimental
The experimental group will perform a 5-week motor program consisting of 4 bimanual exercises with mirror therapy, to be done at home 30 minutes a day, 5 days a week.
干预措施: Mirror Therapy (Other)
Control Group
Active Comparator
The control group will perform a 5-week motor program consisting of 4 bimanual exercises without mirror therapy, to be done at home 30 minutes a day, 5 days a week.
干预措施: Program without Mirror Therapy (Other)
结局指标
主要结局
Change in Bimanual Performance
时间窗: Baseline, at 5 weeks and at 9 weeks
How Bimanual Performance, assessed with Children's Hand-use Experience Questionnaire, changes by doing the intervention
次要结局
- Change in sterognosis of the impaired hand.(Baseline, at 5 weeks and at 9 weeks)
- Change in moving two-point discrimination of the impaired hand.(Baseline, at 5 weeks and at 9 weeks)
- Change in Tactile Registration of the impaired hand.(Baseline, at 5 weeks and at 9 weeks)
- Change in static two-point discrimination of the impaired hand.(Baseline, at 5 weeks and at 9 weeks)
- Change in single point localisation of the impaired hand.(Baseline, at 5 weeks and at 9 weeks)
- Change in double simultaneous of the impaired hand.(Baseline, at 5 weeks and at 9 weeks)
- Self-reported Quality of Life(Baseline, at 5 weeks and at 9 weeks)
研究者
Anna Ortega I Martínez
Principal Investigator
Universitat Internacional de Catalunya
研究点 (1)
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