| 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
|
|
|
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
|
|
|
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
|
|
|
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. |