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临床试验/NCT06846190
NCT06846190招募中不适用

Effects of Modified Constraint Induced Movement Therapy Versus Virtual Reality Training in Children With Hemiplegic Cerebral Palsy

Riphah International University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
CHEQ (Children's hand-use experience questionnaire)

研究概览

简要总结

Children with hemiplegic cerebral palsy (CP) are characterized by motor impairments mainly lateralized to one side of the body, with greater upper limb than lower limb involvement; these impairments may further limit the daily activities and school participation of children with hemiplegic CP. For the improvement of activity limitations in hemipelagic cerebral palsy children will take 20 hemiplegic cerebral palsy children with the age of 5-16 year all participants will be randomly assign and use modified Constraint induced movement therapy and virtual reality techniques.

mCIMT and Hot pack will be given to group I and unaffected hand will immobilized by a volar resting splint extending from finger tips to the proximal forearm. Use splint every day for at least 5 waking hours individualized, 18-hour program of mCIMT every other day, 3 times per week during a 4-week period. Each modified CIMT session continued for 1.5 hours will give to group I on the other hand VR and Hot pack will give to group II and 18-hour VR program, every other day, 3 times per week for 4 weeks will give Each VR session continued for 1.5 hours. Then evaluate both groups on follow up.

All the data will be collected from Rising Sun Institute by using ABILHAND-KIDS questionnaire and Children's hand-use experience questionnaire. The reliability and validity of tools and mentioned.

The duration of study will be 6-months. Data will be analyzed with the help of SPSS 27

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age range between 5 to 16 years of age.
  • •Medical diagnosis of spastic hemiparetic CP.
  • •At least 20◦wrist and 10◦ active finger extension from full flexion.
  • •More movement deficits in 1 upper extremity (less than 2.5 on the Amount of Use scale (AOU) on the Pediatric Motor Activity Log (PMAL)).
  • •Muscle tone less than 3 on the Modified Ashworth Scale.
  • •Normal or corrected-to-normal vision and hearing.
  • •Classified level I, II, or III of the Manual Ability Classification System ( MACS) for Children with CP

排除标准

  • •Health problems not associated with CP.
  • •Seizure hemispatial neglect.
  • •Orthopaedic surgery on the involved upper extremity.
  • •Botulinum toxin therapy for the affected upper extremity within the past 6 months or within the study period.
  • •Balance problems

研究组 & 干预措施

mCIMT group

Experimental

Clinical experimental: For group -I mCIMT at least 5 waking hours daily for 4 weeks 3 times per week during a 4-week period.

干预措施: mCIMT (Other)

VR Group

Active Comparator

Clinical experimental: For group -II VR 25 minutes of VR program, every other day, 3 times per week for 4 weeks.

干预措施: VR (Other)

结局指标

主要结局

CHEQ (Children's hand-use experience questionnaire)

时间窗: Baseline, 4th week and 8th week

CHEQ has been developed to capture children's perceived quality of performance when using the affected hand in these situations. CHEQ is an internet-based questionnaire containing 29 items (bimanual activities) presented one by one in random order. Test-retest reliability for the three CHEQ scale was: grasp efficacy, ICC=0.91; time taken, ICC=0.88; and feeling bothered, ICC=0.91. Total Maximum score of each component (quality, duration \& psycho-status) was 100 and total maximum score of hand use was 27. Higher the results showed improvement in hand function

ABILHAND-KIDS questionnaire

时间窗: Baseline, 4th week and 8th week

ABILHAND-KIDS questionnaire is a valuable tool to assess a child's unimanual and bimanual upper limb activities. The reliability of the ABILHANDS-Kids is good across different observers as a performance- and capacity-based rating method. Test-retest reliability was 0.92. Total Maximum score was 42, mid score was 21 and minimum score was 0. Higher scores showed improvement in activity level of hand use

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 (1)

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