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CTRI Number  CTRI/2025/03/082254 [Registered on: 13/03/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Therapeutic Exercises for Children with Cerebral Palsy  
Scientific Title of Study   Effect of Cage Therapy on Trunk Control in Children with Spastic Cerebral Palsy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Imtisenla Tzudir 
Designation  PG Scholar 
Affiliation  Amity Institute of Health Allied Sciences  
Address  Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University Sector 125 Noida 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  8787547228  
Fax    
Email  Imtisenla.tzudir@s.amity.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Gupta  
Designation  Associate Professor  
Affiliation  Amity Institute of Health Allied Sciences  
Address  Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University Sector 125 Noida 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9810280418  
Fax    
Email  ngupta4@amity.edu  
 
Details of Contact Person
Public Query  
Name  Ruchika Kalra 
Designation  Teaching Associate  
Affiliation  Amity Institute of Health Allied Sciences  
Address  Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University Sector 125 Noida 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9718417185  
Fax    
Email  rkalra1@amity.edu  
 
Source of Monetary or Material Support  
Reborn Physiotherapy and Neuro Rehabilitation Advance Pediatric and Neuro Rehab Center Shakti Khand-4, Indirapuram Ghaziabad-201014 
 
Primary Sponsor  
Name  Imtisenla Tzudir  
Address  Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University Noida Uttar Pradesh  
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Himandri Kapil   Reborn Physiotheapy and Neuro Rehabilitation Advance Pediatric and Neuro Rehab Center   Plot No. 649, Ground Floor, Shakti Khand-4, Near Kailash Mansarovar Bhawan, Indirapuram, Ghaziabad 201014, Ghaziabad UTTAR PRADESH
Ghaziabad
UTTAR PRADESH 		 9560809242

himandri.k@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional NTCC Committee Amity Institute of Health Allied Sciences, Amity University Noida Uttar Pradesh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cage therapy   Cage Therapy or the "Universal Exercise Unit," which could be an effective intervention to enhance physical function. This unique approach utilises a cage-like specially designed structure with belts, weights, and bungee cords that provide resistance based on the position of the cords and also dependent on the condition of the patient. It directly tackles the underlying muscle and postural dysfunction associated with the condition  
Comparator Agent  Conventional Therapy   In conventional therapy exercise like strengthening, stretching and balance activities of the lower limb are followed  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Diagnosis of Spastic Diplegic Cerebral Palsy (SDCP)
2. GMFCM III and IV
3. TCMS score of 9
 
 
ExclusionCriteria 
Details  1. Severe disability
2. Uncontrolled seizures
3. Waiting for orthopedic surgery
4. Hearing deficits
5. Any cardiac anomalies affecting exercise tolerance
6. Complicated systemic disorders
7. Usage of botulinum toxin A injection within three months prior to study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Trunk Control Measurement Scale, Trunk Impairment Scale.  Baseline, post 3rd week, post 6th week  
 
Secondary Outcome  
Outcome  TimePoints 
Pediatric Balance Scale   Baseline, post 3rd week, post 6th week  
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   17/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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



 



 
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