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临床试验/NCT07248735
NCT07248735招募中不适用

Effects of Constraint Induced Movement Therapy With and Without Robotic Glove on Dexterity and Hand Grip Strength in Children With Hemiplegic Cerebral Palsy

Riphah International University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年10月29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
34
试验地点
1
主要终点
Grip Strength Test

研究概览

简要总结

This study investigates the impact of CIMT, with and without robotic gloves, on hand dexterity and grip strength in children with hemiplegic CP, aiming to enhance motor skills and promote independence in daily activities. Conducted as a randomized controlled trial at DHQ Hospital, Mandi Bahauddin, the study involves two groups of children aged 6-12 with hemiplegic CP. One group of 17 children will receive CIMT alone with standard treatment, while the other 17 will receive CIMT combined with robotic glove assistance. The robotic glove device aids in flexion, extension, and individual finger movements, providing support for both isolated and coordinated finger actions. Each therapy session will last six hours and be held three to five days a week over four to eight weeks.

详细描述

Hemiplegic cerebral palsy (CP) often affects one side of the body, limiting functional abilities. Constraint-Induced Movement Therapy (CIMT) is a common intervention where the unaffected hand is restricted to encourage the use of the affected hand. Recently, the addition of robotic gloves has been proposed to improve outcomes, as they offer mechanical support and feedback to the affected hand. This study investigates the impact of CIMT, with and without robotic gloves, on hand dexterity and grip strength in children with hemiplegic CP, aiming to enhance motor skills and promote independence in daily activities. Conducted as a randomized controlled trial at DHQ Hospital, Mandi Bahauddin, the study involves two groups of children aged 6-12 with hemiplegic CP. One group of 17 children will receive CIMT alone with standard treatment, while the other 17 will receive CIMT combined with robotic glove assistance. The robotic glove device aids in flexion, extension, and individual finger movements, providing support for both isolated and coordinated finger actions. Each therapy session will last six hours and be held three to five days a week over four to eight weeks.

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

  • •Children aged 6-12 years with Hemiplegic CP.
  • •Both Genders will be included.
  • •Fulfilling the CIMT criteria i.e. Up to 20 Degree Wrist Extension, up to 10 Degree
  • •Thumb Abduction and Up to 10 Degree Finger Extension.
  • •GMFCS level of 1 and
  • •MAC Grade 2 and
  • •Ability to understand and follow simple instructions.

排除标准

  • •Severe cognitive impairment or intellectual disability.
  • •Presence of other neurological disorders such as epilepsy.
  • •Children currently participating in other intensive physical therapy programs.

研究组 & 干预措施

Group A

Active Comparator

Experimental group

干预措施: CIMT with robotic glove (Other)

Group B

Active Comparator

Control group

干预措施: CIMT with standard rehabilitation (Other)

结局指标

主要结局

Grip Strength Test

时间窗: 4-8 weeks

The grip strength test and pinch strength is used to assess function of the hand using dynamometer. Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength

Box and Block Test

时间窗: 4-8 weeks

The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. The BBT is composed of a wooden box divided in two EFFECTS OF CIMT WITH AND WITHOUT ROBOTIC GLOVES IN CHILDREN WITH HEMIPLEGIC CP 11 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

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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