A Prospective Study (RCT) to Evaluate the Efficacy of an Individualized Comprehensive Home-Centred Activity Based Therapy for Children With Diplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change in distance covered as measured by 6 minute walk test (in metres)
研究概览
简要总结
Activity based therapy is gaining interest for rehabilitation of children with cerebral palsy (CP). A home-based comprehensive programme structured on the principles of activity based therapy seems to hold promise in the field of rehabilitation of children with diplegic CP.This may reduce morbidity as well as promote better quality of life in these children . In this backdrop our study has been planned with an aim to evaluate the efficacy of a comprehensive home-centred activity based programme for children with diplegic CP.
详细描述
Study settings:
This study will be conducted on children enrolled in the Outpatient Clinic of Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh and the associated Outpatient Department of PRAYAAS (A project of Indian Council for Child Welfare) located at Dakshin Marg, Sector 38 B, Chandigarh which is a rehabilitation centre for children with cerebral palsy where the neurology unit of the department provides outreach services.
Study Period:
Oct 2014 to Dec 2015
Study population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of either sex aged 5 to 12 years clinically diagnosed to have spastic diplegic cerebral palsy .
- •GMFCS either II or III
- •Minimum visual acuity of 6/60
- •Ability to follow simple single step commands
- •Either parent should be willing and capable of following instructions and maintaining activity log.
排除标准
- •Children with fixed contractures and deformities in lower limbs affecting stance and gait.
- •Children who have received botulinum toxin injection or undergone orthopaedic corrective surgery in the past one year.
- •Children with concomitant chronic systemic illnesses that can interfere with execution of physiotherapy or activity based therapy.
- •Children with any acute illness.
研究组 & 干预措施
Group A
Individualized comprehensive home centred activity based programme. Simple activities would be advised on the basis of child's individual characteristics and parental expectations. These would include but would not be limited to (a) Standing up from squatting position to catch an object of interest.
(b) Squatting from standing position to pick an object of interest. (c) Walking to reach an object of interest. (d) Climbing up steps to get an object of interest. (e) Climbing down steps to keep the above object of interest. (f) Cycling (g) Kicking a football (h) Dancing
干预措施: Individualized comprehensive home centred activity based programme (Other)
Group B
Conventional Physiotherapy Conventional physiotherapy would include and would not be limited to
- Passive stretching exercises for spasticity reduction
- Gait exercises
- Walking on treadmill
- Lower limb strengthening exercises
- Exercises for balance improvenet
干预措施: Individualized comprehensive home centred activity based programme (Other)
结局指标
主要结局
Change in distance covered as measured by 6 minute walk test (in metres)
时间窗: six months
The test is performed on a quadrangular ,plain floor which has a marked rectangular area,the perimeter of which is thirty four metres.Subject and his/her attendant is initially given demonstration and then he/she is made to walk along the marked surface continuously for six minutes and the same is videographed..The distance covered is measured and recorded.
次要结局
- Change in Modified tardieu Scale Score(3 months; 6 months)
- Change in 10metres fast walk score(baseline, 3 months; 6 months)
- Change in Gross Motor Function Measure 88 D & E Scores (GMFM-88 D & E)(3 months; 6 months)
- Change in Cerebral Palsy Quality of Life (Primary Care Giver ) Score (CPQoL)(3 months; 6 months)
- Change in Modified Ashworth Scale Score(3 months; 6 months)
研究者
DR J N GOSWAMI
Senior Resident
Post Graduate Institute of Medical Education and Research, Chandigarh