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临床试验/NCT05358028
NCT05358028Unknown不适用

Comparison of Hand Arm Bimanual Intensive Technique With and Without Lower Extremity on Functional Status of Hemiplegic Cerebral Palsy

Riphah International University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
six minute walk test

研究概览

简要总结

The aim of this study is to determine the functional status of upper extremity using HABIT & HABIT-ILE. And to compare the effects of HABIT with and without lower extremity technique on functional status of hemiplegic cerebral palsy

详细描述

Hemiplegic cerebral palsy children have impairments in bimanual coordination above and beyond their unilateral impairments .Hand-arm bimanual intensive therapy tends to show a constructive impact on hand function in children with hemi paretic cerebral palsy.

Hand-Arm Bimanual Intensive Therapy (HABIT) designed for children with unilateral CP, which when combines bimanual upper extremity training with activities involving the trunk and lower extremities making it HABIT-ILE.

A bimanual training program that continuously focusses on postural control and lower limb functional activity is all covered in HABIT-ILE Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) involves the concepts of motor skill learning and intensive training to both the UE and LE.

However it is not known that whether combined upper and lower extremity training in an intensive protocol is more efficacious or not thus Rationale of this study would be to figure out that if an intensive protocol is devised involving upper and lower extremities both would it be more product full or not. This study would be significant in a way that we know cerebral palsy is a lifelong challenging condition for both children and their caregivers thus new and emerging treatments can be fruitful for progression.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed cases of hemiplegic cerebral palsy
  • GMFCS level 2,3,4
  • Ashworth scale 0-2

排除标准

  • History of recent orthopedic surgery
  • History of seizures
  • Visual impairment

结局指标

主要结局

six minute walk test

时间窗: 6 weeks

The object of this test is to walk as far as possible for 6 minutes. the patient will walk back and forth in this hallway. Six minutes is a long time to walk, so the patient will be exerting. he will probably get out of breath or become exhausted. patients are permitted to slow down, to stop, and to rest as necessary. he may lean against the wall while resting, but resume walking as soon as patients are able. the patient will be walking back and forth around the cones. the patient should pivot briskly around the cones and continue back the other way without hesitation Predictive equation for males: 6 Minute Walk Distance (m) = 867 - (5.71 age, yrs) + (1.03 height, cm) Predictive equation for females: 6 Minute Walk Distance(m) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22 BMI).

Assisting hand Assessment scale

时间窗: 6 weeks

AHA assesses the child's spontaneous and regular way of handling objects during play in natural settings, and is therefore a measure of usual everyday performance. AHA is appropriate to use for children with hemiplegic cerebral palsy (CP). 22 items consisting of observable actions, e.g. manipulates, varies grips, releases, and holds. The session is recorded and scored based on the 22 items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective). The range of sum scores is 22-88 points.

Box And Block

时间窗: 6 weeks

The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. Clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Score each hand separately. Higher scores are indicative of better manual dexterity. During the performance of the BBT, the evaluator should be aware of whether the client's fingertips are crossing the partition. Blocks should be counted only when this condition is respected. Furthermore, if two blocks are transferred at once, only one block will be counted.

Gross motor function measure

时间窗: 6 week

The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. SCORING KEY 0 = does not initiate 1. = initiates 2. = partially completes 3. = completes NT = Not tested

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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