A Randomized Control Trial to Compare the Efficacy of Caregiver Directed Home Based HABIT With and Without Tele-rehabilitation in Cerebral Palsy Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1) To compare the manual ability (ABILHAND-Kids) of caregiver directed home based HABIT with and without Tele-rehabilitation in CP children.
研究概览
简要总结
Cerebral palsy (CP) is a group of permanent, but often changing disorders of movement and or posture motor function, which are due to a non-progressive lesion or abnormality of the developing immature brain(1).Worldwide incidence range between 2 and 2.5 per 1000 live births(2). Prevalence of CP in India ranges between 21 to 173 per 100 (3). The etiology of CP is multifactorial and it can be injury to developing brain during prenatal ,natal and post natal eg:-congenital, genetic, inflammatory ,infectious, anoxic, traumatic and metabolic(4). Some authors recommended to use a simplified classifications like unilateral or bilateral with indicating upper limb or lower limb is involvement(5).CP can be classified according to topography and tone. Topographically, they are classified as monoplegia, hemiplegia, quadriplegia and diplegia(2). By tone, CP is classified into spastic, hypotonic, mixed, ataxic and dyskinetic (2) .
The comorbidities associated with CP include speech and language disorders, intellectual disability, visual disability, hearing disability, motor impairment and epilepsy(6).
For assessing the level of physical ability, various tools can be used. The commonly used measures are Gross Motor Function Classification System (GMFCS) for gross motor and Manual Ability Classification System (MACS) for hand functions in Cerebral Palsy children. GMFCS & MACS enable health professionals to quantify motor function and manual ability, establish therapeutic goals and improve the communication with relatives or caregivers(7). The children who can ambulate with or without assistive devices categorized under the first three GMFCS levels(8).Other scales like functional mobility(FMS) scale are also used. Mobility is rated for three distances in this scale representative of the home (5 m), school (50 m), and community (500 m) settings. These distances were chosen based on clinical judgment and are used as a guide, not as the exact same distances. For each distance a rating of 1–6 is given depending on the assistance or help required, ranging from wheelchair (1) to independent without devices on all surfaces (6).(9)
CP causes lots of challenges to not only the affected persons but also the family, which can be economical, psychological and social especially in low and middle income settings. Most of the time therapies for CP children are provided by trained therapists at specified centres, which add to the burden of caregivers. So caregiver driven home based rehabilitation is more appropriate.
Greater than 80% of children with CP have an upper extremity involvement, which can significantly affect the child’s activities of daily living (ADL) and quality of life. Due to damage to the motor cortex and corticospinal tract, children with CP faces difficulties in precise grasping and fine motor control and can develop an abnormal movement of hand (10).
Rehabilitation literature review indicates that the most effective interventions in CP children are motor learning-based interventions delivered at high intensity and which focus on function(11). One of such intensive therapy studied extensively is constraint-induced movement therapy (CIMT). Recent evidence has shown that children with CP could benefit from CIMT for unimanual hand ability. CIMT focuses on the practice and exercises of the involved hand, and it restrains the use of the non-involved hand during treatment (focuses only on the affected hand). This may be not practical for children to perform ADL, since most ADL tasks require use of two hands working together for activities such as opening bottles, dressing etc. Bimanual therapy is a general term for repetitive task practice using both the hands, rather than one hand, to complete functional activities. It is a child-friendly technique without the physical constraint of the less-affected hand (10).
Hand-arm bimanual intensive therapy (HABIT) is a form of intensive bimanual child friendly training effective in improving the amount and quality of involved upper-extremity use. HABIT is an example of such intensive therapy. In HABIT affected hand or most affected hand used as assisting hand in intervention(11).
The HABIT involves prioritization of the bimanual coordination skills of hands, and it also maintains the intensive quality of constraint therapy. The structured practice includes two specific types: one is the whole-task practice (e.g.,
performing the activity for at least 15 to 20 minutes) and the other is the part-task practice (e.g., practicing target movements repeatedly) (9).
Tele-rehabilitation is defined as the set of instruments and protocols aimed at prescribing rehabilitation at a distance. This can be an appropriate strategy to address health issues in low and middle-income countries and remote areas with limited access rehabilitation centre (12). Tele-rehabilitation benefits the children with physical disabilities to be in contact with their rehabilitation specialist, and maintain improvements, and it could simultaneously reduce the burden on parents.
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Eliasson A-C, Krumlinde-Sundholm L, Rösblad B, Beckung E, Arner M, Öhrvall A-M, et al. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006;48(7):549–54.
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Hand Arm Bimanual Intensive Training • The Brain Recovery Project [cited 2021 Apr 5]. https://www.brainrecoveryproject.org/wp content/uploads/2020/01/H-HABIT-Training-Manual-Hx-2.pdf
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Burgess A, Boyd RN, Ziviani J, Sakzewski L. A systematic review of upper limb activity measures for 5-to 18-year-old children with bilateral cerebral palsy. Aust Occup Ther J. 2019;66(5):552–67.
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Arnould C, Penta M, Renders A, Thonnard J-L. ABILHAND-Kids: a measure of manual ability in children with cerebral palsy. Neurology. 2004;63(6):1045–52.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •Children with cerebral palsy between 6 years and 18 years.
- •Ability to actively grasp an object on table with affected hand.
- •Ability to follow two-step instructions and complete testing.
- •(Child can listen and follow the command) 4) Caregiver to provide one-to-one attention to the child during home training activities.
- •To score grades of 2 to 4 on MACS grading, and 1 to 4 on GMFCS.
- •Ability to use devices smart phone, desktop and make video call by parent.
排除标准
- •Child unable to follow two-step instructions.
- •Normal upper limb function, Grade 1in MACS.
- •Visual problems preventing performance of intervention/testing tasks.
- •Caregivers unable to attend the entire duration of intervention.
- •Non-availability of the caregiver.
- •Botoulinum toxin injection in the upper limb in past 6 months.
结局指标
主要结局
1) To compare the manual ability (ABILHAND-Kids) of caregiver directed home based HABIT with and without Tele-rehabilitation in CP children.
时间窗: baseline at 0week, 9 and 12 weeks of follow up.
次要结局
- 1) To compare the manual ability (MACS) of caregiver directed home based HABIT with and without Tele-rehabilitation in CP children. 2) To compare the gross motor function (GMFCS E&R) of caregiver directed home based HABIT with and without Tele-rehabilitation in CP children. 3) To compare family burden using Family burden questionnaire of caregiver directed home based HABIT with and without Tele-rehabilitation in CP children.(baseline at 0week, 9 and 12 weeks of follow up.)
