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临床试验/CTRI/2021/06/034399
CTRI/2021/06/034399已完成不适用

A Pilot Study to evaluate the efficacy of Robotic Biofeedback-based upper limb rehabilitation in children with Hemiplegic Cerebral Palsy

Armed Forces Medical Research Cell2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月7日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
To compare the efficacy of robotic biofeedback based rehabilitation for upper limb with that of conventional physiotherapy in 5to 18 year old children and adolescents with hemiplegic CP with Gross Motor Function Classification Scale Scores between I to III as measured by change in grip strength of affected hand at one year of initiation of therapy

研究概览

简要总结

Cerebral palsy (CP) is a common neurodevelopmental  disorder of childhood, occurring secondary to a static insult to the developing fetal or infant brain (1).The worldwide prevalence of CP is 2 to 2.5 per1000 live births (1). Hemiparetic CP comprises of about one third of the total cases of CP (2).The incidence of hemiparetic CP in North India is noted to be 13.8% among all CP children (3). Multiple forms of physical therapy are practised for CP rehabilitation , each one having its unique pros and cons (4).Existence of these different schools of therapy indicates the absence of a universally effective management technique in CP.

Biofeedback-based therapy is a recent concept wherein children with CP are allowed to  interact with virtual events that motivate them to perform certain movements and undergo motor rehabilitation (5).Activity based therapy and robot assisted rehabilitation are two other contemporary concepts in rehabilitation.Activity based therapy utilizes the principle of neuroplasticity whereby functional rehabilitation is achieved through repetitive performance of activities(6). Robotic upper limb rehabilitation is the technique of  application of computer-controlled robotic devices for  goal directed task-specific functioning (7).Biofeedback is the provision of external sensory inputs about a particular movement or action that is being done during rehabilitation (8).Biofeedback  keeps the patient motivated and engaged in structured activity as well as provides real-time inputs for corrective action/modification of his or her action (9).Though there have been reports of positive effects of  robotic rehabilitation in children with CP, there is nouniversally accepted common protocol related to the technique  Current literature review does not mention any Indian trial on robotic rehabilitation in hemiparetic CP. Hence this is a novel research area.

CP is commonly encountered not only in the pediatric out-patient departments(OPD) of our service hospitals but also in Neurology OPDs since increasing number of these children are transitioning to adult care owing to standardized medical practices. Robotic upper limb rehabilitation with biofeedback appears promising in this regard in being a novel, effective,feasible,user-friendly  therapeutic regimen  which may revolutionize rehabilitation medicine. All children enrolled in the study shall receive physical therapy and hence , would be benefitted. T-lhe therapy is highly unlikely to cause any adverse effects to the patients other than the extremely rare known risks of physical therapy, the chances of occurrence of which would be remote as the programme would be supervised by a certified physical medicine and rehabilitation specialist. If found effective, mass scale implementation of this therapeutic model in our hospitals as well as  rehabilitation centres would be suggested ,which would prove economical in the long run .

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children of either sex aged 5 to 18 years clinically diagnosed to have hemiplegic cerebral palsy Gross Motor Functional Classification System Score or GMFCS Score either I to 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 who have received botulinum toxin injection in upper limb in the past one year prior to enrolment Children who have undergone orthopaedic corrective surgery in the past one year prior to enrolment Children with concomitant chronic systemic illnesses that can interfere with execution of intervention or physiotherapy Children with any acute illness that can interfere with execution of intervention or physiotherapy.

结局指标

主要结局

To compare the efficacy of robotic biofeedback based rehabilitation for upper limb with that of conventional physiotherapy in 5to 18 year old children and adolescents with hemiplegic CP with Gross Motor Function Classification Scale Scores between I to III as measured by change in grip strength of affected hand at one year of initiation of therapy

时间窗: 12 months

次要结局

  • To compare the change in following scores between 5 to18 year old children and adolescents with hemiplegic CP with GMFCS I to III receiving robotic biofeedback based rehabilitation for one year with those receiving conventional physiotherapy for one year(Quality of Upper Extremity Skills Test Scores or QUEST scores at 12 months and 15 months of initiation of therapy)

研究者

发起方
Armed Forces Medical Research Cell
申办方类型
Government funding agency

研究点 (2)

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