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CTRI Number  CTRI/2024/01/061680 [Registered on: 22/01/2024] Trial Registered Prospectively
Last Modified On: 15/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Enhancing Performance in Children with Tight Muscles from Lifting weights Exercise 
Scientific Title of Study   Effect of Progressive Resisted Exercise and Functional Progressive Resisted Exercises on Functional Outcome 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  Dr Sapna Dhiman PT 
Designation  Assistant Professor 
Affiliation  Delhi Pharmaceutical Sciences and Research University 
Address  Room no. 610, 6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University Mehrauli - Badarpur Rd, opp. Sainik Farm, Sector 3, Tughlakabad, New Delhi, 110017

South
DELHI
110017
India 
Phone  8588055147  
Fax    
Email  sapnaphysio@dpsru.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sapna Dhiman PT 
Designation  Assistant Professor 
Affiliation  Delhi Pharmaceutical Sciences and Research University 
Address  Room no. 610, 6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University Mehrauli - Badarpur Rd, opp. Sainik Farm, Sector 3, Tughlakabad, New Delhi, 110017

South
DELHI
110017
India 
Phone  8588055147  
Fax    
Email  sapnaphysio@dpsru.edu.in  
 
Details of Contact Person
Public Query
 
Name  Radhika 
Designation  Post Graduate Student 
Affiliation  Delhi Pharmaceutical Sciences and Research University 
Address  Room no. 608, Delhi Pharmaceutical Sciences and Research University, School of Physiotherapy,Gate Number 1, Mehrauli - Badarpur Rd, opp. Sainik Farm, Sector 3.

South
DELHI
110017
India 
Phone  8368876469  
Fax    
Email  mittalradhika10@gmail.com  
 
Source of Monetary or Material Support  
School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University New Delhi, 110017 
 
Primary Sponsor  
Name  School of Physiotherapy, Delhi Institute of Pharmaceutical Sciences and Research University 
Address  Gate Number 1, Mehrauli - Badarpur Rd, opp. Sainik Farm, Sector 3, Tughlakabad, New Delhi, Delhi 110017 
Type of Sponsor  Research institution 
 
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 Sapna Dhiman PT  School of physiotherapy clinic  Room no.1 Ground Floor of School of Physiotherapy Gate Number 1, Mehrauli - Badarpur Rd, opp. Sainik Farm, Sector 3, Tughlakabad, New Delhi, 110017
South
DELHI 
8588055147

sapnaphysio@dpsru.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Students research development committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P949||Disorder of muscle tone of newborn, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A (Progressive resisted exercise group)  The progressive resisted exercise will be done for 45 minutes, 3 times a week for 6 weeks (Knee extension, calf raise, Knee flexion). Subjects will be evaluated pre and post-intervention. For every 2 weeks progression of weight by 10% increases. 
Intervention  Group B (Functional progressive resisted exercises)  The Functional progressive resisted exercise will be done for 45 minute 3 times a week for 6 weeks (Sit to stand, half-kneeling to standing up, and Side step-up). Subjects will be evaluated pre and post-intervention. For every 2week the progression of weight by 10% increases.  
Comparator Agent  Group C (Control group)  No exercise will be given only monitoring the individual  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Age group between 6 to 12 years.
2. Child with spastic cerebral palsy.
3. Children have sufficient co-operation and cognition to follow instructions.
4. Children with GMFCS levels between 1 and 3.
 
 
ExclusionCriteria 
Details  1. Child having unstable seizures.
2. Received treatment for spasticity and any surgical procedure up to 3 months before study.
3. Any botulinum toxic type A injection before study.
4. Children suffering from other disease that interfere with physical activity.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Range of motion -goniometer
2. Isometric strength-handheld dynamometer
3. 10m walk test
4. Gross Motor Function Measurment-88 
Baseline (P0)
After 6 week (P1) 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   24/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/01/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Subjects are selected on the basis of inclusion and exclusion criteria. The will be screened based on gross motor function classification system (GMFCS). The subjects that came under level 1 to level 3 will be recruited for the study.

Then the subject will be divided into 2 groups randomly by using the chit method. The individual 8 RM test was used to determine the training load for each exercise. About 80% of 1 RM is equivalent to 8 RM. Once the kids were comfortable with the training program and could complete the exercise, the 8 RM test processes were started accurately. The child began by figuring out the 8 RM. for three repetitions (without load) to practice the proper performance: every repetition needed to be carried out by a whole (potential) range of motion, Next, two three-repeat warm-up trials were conducted at 50% and 70% of the anticipated eight repetition maximum, respectively. The predicted 8 RM is determined by the child’s weight. After the third and actual test trial, the youngster was told to continue at 100% of the estimated 8 RM until they reached a maximum of 10 repetitions or until they temporarily became exhausted physically. If two consecutive repetitions were executed improperly, the trial was terminated. Repetitions that were conducted correctly were not counted.(16)

The heavy load for the 1-RM test was initially set at 100% to 150% of the subject’s body weight, based on the subject’s functional level and performance in the light and medium practice trials. Unless the medium weight practice trials were particularly demanding, those in GMFCS levels I and II often began at 150% body weight. In such case, the starting load was lowered to 125% body weight. When testing, those in GMFCS level III often began at 100% to 125% of their body weight, unless the assessor thought the person could begin at a higher load. Following each successful press, testing loads were increased by 10% to 20% in accordance with guidelines provided by the American College of Sports Medicine for evaluating lower extremity muscles.

Estimated 1RM = Load Lifted (lb)/ [1.0278 − (0.0278 × Repetitions Lifted)(17)

The protocol will be done for 45 min 3 times a week for 6 weeks subjects will be evaluated pre and post intervention. For every 2week progression of weight by 10% increases.

 
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