跳至主要内容
临床试验/CTRI/2025/03/082254
CTRI/2025/03/082254尚未招募3 期

Effect of Cage Therapy on Trunk Control in Children with Spastic Cerebral Palsy

Imtisenla Tzudir1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年3月17日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
Trunk Control Measurement Scale, Trunk Impairment Scale.

研究概览

简要总结

The lack of comparative studies between conventional therapy and cage therapy in relation to their effectiveness in  spastic cerebral palsy emphasise the requirement for research. To improve the  trunk control  for spastic cerebral palsy children to improve their daily living.

Aims

To study the effectiveness of cage therapy on trunk control in SDCP children

Objectives

Primary Objective

To study the effectiveness  of cage therapy on trunk control as measured by Trunk Instability Scale  (TIS) in SDCP children

To study the effectiveness of cage therapy on trunk control by Trunk Control Measurement Scale Score (TCMS) in SDCP children

 Secondary Objective

To study the effectiveness of cage therapy on balance as measured by Pediatric Balance Scale (PBS) in SDCP children.

 Hypothesis

 Null Hypothesis

The will be no significant difference in  trunk control and balance between cage therapy and conventional therapy in SDCP children

 Alternate Hypothesis

There will be significant difference in trunk control and balance between cage therapy and conventional therapy in SCP children

Procedure

The treatment protocol will be for  6weeks,  6 sessions per week with a time duration of 60 minutes

 GROUP A Conventional Therapy  (Control group)

GROUP B Cage therapy ( Study group)

 The control group received the following exercise protocol for a duration of 60 minutes where manual assistance was provided by the therapist

Exercise protocol for week 1 to  week 3

 Passive stretching of both the lower limbs- 3 reps with 10 sec hold

Quadruped  position with reaching out activities  10 reps, 2 sets with 30 seconds rest in between

Kneeling position along with peg board activity 5 reps, 2 sets with 30 seconds rest in between.

Half kneeling with trunk rotation  5 reps (on each leg), 2 sets with 30 seconds rest

in between

Sit to stand 10 repetitions, 3 sets with 30 seconds rest in between.

Sitting with lateral and forward reaching activity  6 reps, 3 sets

Sitting with flexion and extension of lower trunk 6 reps, 3 sets

 Exercise protocol for week 3 to week 6

 Passive stretching of both the lower limbs 3 reps with 10 seconds hold

Standing with eyes open  15 minutes

Standing on a balance board and perform  activities such as throwing a ball into a

basket ring placed in front of the child10 minutes

Weight shift from side to side, forward and backward 5 times on each side

Standing and kicking a ball 5 times on each side

 The study group will receive spider cage therapy for a duration 60 minutes  where the child will adapt different posture. Functional activities that can be performed are

Exercise protocol for week 1 to  week 3

 Passive stretching of both the lower limbs 3 reps with 10 sec hold

Quadruped  position with reaching out activities  10 reps, 2 sets with 30 seconds

rest in between

Kneeling position along with peg board activity  5 reps, 2 sets with 30 seconds rest

in between

Half kneeling with trunk rotation  5 reps (on each leg), 2 sets with 30 seconds rest

in between

Sit to stand 10 repetitions, 3 sets with 30 seconds rest in between

Sitting with lateral and forward reaching activity 6 reps, 3 sets

Sitting with flexion and extension of lower trunk 6 reps, 3 sets

 Exercise protocol for week 3 to week 6

 Passive stretching of both the lower limbs 3 reps with 10 seconds hold

Standing with eyes open 15 minutes

Standing on a balance board and perform  activities such as throwing a ball into a

basket ring placed in-front of the child 10 minutes

Weight shift from side to side, forward an backward 5 times on each side

Standing and kicking a ball 5 times on each side

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Diagnosis of Spastic Diplegic Cerebral Palsy (SDCP)
  • GMFCM III and IV
  • TCMS score of 9.

排除标准

  • Severe disability
  • Uncontrolled seizures
  • Waiting for orthopedic surgery
  • Hearing deficits
  • Any cardiac anomalies affecting exercise tolerance
  • Usage of botulinum toxin A injection within three months prior to study.

结局指标

主要结局

Trunk Control Measurement Scale, Trunk Impairment Scale.

时间窗: Baseline, post 3rd week, post 6th week

次要结局

  • Pediatric Balance Scale(Baseline, post 3rd week, post 6th week)

研究者

发起方
Imtisenla Tzudir
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Imtisenla Tzudir

Amity Institute of Health Allied Sciences

研究点 (1)

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