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临床试验/NCT07121426
NCT07121426已完成不适用

Effects of Lower Limb Intensive Functional Training on Gait and Balance in Spastic Diplegic Cerebral Palsy Children

University of Lahore2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2023年1月22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
82
试验地点
2
主要终点
Gross motor function measure

研究概览

简要总结

The goal of this Randomized control trial was to evaluate the outcome of limb intensive functional training (LIFT) on gait and balance in spastic diplegic cerebral palsy children with age 3-7 years.

The main questions this study has answered were:

  • To access the improvement in children's gait and balance by providing interventions in clinical setting/ standardized environment and then at home environment. This study will check does the improvement in capacity level also improve their performance level in spastic diplegic CP children after getting targeted, activity focused and therapeutic interventions.
  • Researcher will compare the effects of intervention on both groups. Control group will receive Conventional physical therapy and traditional gait training at clinical setting while Experimental group will receive LIFT and conventional physical therapy at home settings provided by their caregivers. Both group will receive intervention 5days/week for 20 consecutive weeks.

详细描述

GMFCS level 3 and MAS level 2 children were eligible to participate in study and Gross Motor Functional Measure (GMFM-88) was used to access Motor Capacity. 10-meter walk test, timed up and go test and 30 sec chair rise tests was used to access Motor Performance.

Method and Procedures of the research were explained to the patients earlier to data collection. Any query was explicated on the spot.

Group A: The Control group received conventional physical therapy (Stretching followed by Strengthening program and traditional gait training) at clinical setting.63 Stretching muscles were hip flexors, hip adductors, hamstrings and calf and stretching applied for 30 sec with 30 sec rest for 3-5 times for each muscle group with in pain limit followed by strengthening exercise for week muscle which includes the strengthening of anti-gravity muscles of lower limb they are: Quadriceps, Gluteus maximus and soleus performed in 3 groups. Each group contain 10 rep for each week muscle group. Conventional Physical therapy applied 5 days/week for consecutive 20 weeks. They were also guided to perform activities at home but they're unbound to do the designed activities freely.

Group B: The experimental group received Lower limb intensive functional training (LIFT) at home environment and conventional physical therapy at clinical setting. LIFT was provided at home environment for 3 hours/day, 5days/week for 5 months.31 A log book was maintained and the goals and strategies were guided to child's parents. 3 hours' treatment was performed in intervals at different time of the day. LIFT helped child in motor learning, skill progression and resistance training to target the strength, proprioception and coordination impairments of the lower extremities.64 Motor learning was based on Strength domain (Cycling) and progression from smooth to rough surface. Balance and Coordination domain involves activities such as (ball kicking with alternate legs and Static standing) and progression was done by increasing accuracy and complexity. Proprioception domain (Vertical jumping, sit to stand and cursing) while knee-immobilizers applied if needed and progression number of repetitions and sets was increased over time. Skill progression was used to challenge the LIFT and make it intensive enough to obtain changes in motor skills and function. AFO's were required during therapy session if needed.

Caregiver were provided proper guidelines before implementing the treatment at home. 3 training sessions was given prior to treatment. A log book was also provided to get the structured record of the treatment. Further videos and mode of tele-rehabilitation was used for supervision and guidance throughout the study. Therapist closely monitored the activities by checking daily logs.

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
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with Spastic diplegic CP with aged 3-7 years Children of both gender Children with MAS level-2 Children with GMFCS level-3 The ability of caregivers to provide one-on-one attention to the child during dailyactivities

排除标准

  • Visual problems preventing performance of interventions and testing tasks59 Any orthopedic or neuro-surgery done in last 1 year60 Children with any other neurological conditions61 Children with uncontrolled seizures62

结局指标

主要结局

Gross motor function measure

时间窗: at baseline and after 20 weeks

GMFM-88 version and clause C, D and E will be used in this study.

次要结局

  • 10 Meter Walk Test (10mwt)(at baseline and after 20 weeks)
  • Timed Up and Go Test (Tug)(at baseline and after 20 weeks)
  • 30-sec chair rise test(at baseline and after 20 weeks)

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Sponsor

研究点 (2)

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