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Clinical Trials/CTRI/2024/01/061680
CTRI/2024/01/061680
Not yet recruiting
Phase 2

Effect of Progressive Resisted Exercise and Functional Progressive Resisted Exercises on Functional Outcome in Children with Spastic Cerebral Palsy

School of Physiotherapy, Delhi Institute of Pharmaceutical Sciences and Research University1 site in 1 country30 target enrollmentStarted: January 24, 2024Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
School of Physiotherapy, Delhi Institute of Pharmaceutical Sciences and Research University
Enrollment
30
Locations
1
Primary Endpoint
1. Range of motion -goniometer

Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

Ages
6.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age group between 6 to 12 years.
  • Child with spastic cerebral palsy.
  • Children have sufficient co-operation and cognition to follow instructions.
  • Children with GMFCS levels between 1 and 3.

Exclusion Criteria

  • Child having unstable seizures.
  • Received treatment for spasticity and any surgical procedure up to 3 months before study.
  • Any botulinum toxic type A injection before study.
  • Children suffering from other disease that interfere with physical activity.

Outcomes

Primary Outcomes

1. Range of motion -goniometer

Time Frame: Baseline (P0) | After 6 week (P1)

2. Isometric strength-handheld dynamometer

Time Frame: Baseline (P0) | After 6 week (P1)

3. 10m walk test

Time Frame: Baseline (P0) | After 6 week (P1)

4. Gross Motor Function Measurment-88

Time Frame: Baseline (P0) | After 6 week (P1)

Secondary Outcomes

  • NA(NA)

Investigators

Sponsor
School of Physiotherapy, Delhi Institute of Pharmaceutical Sciences and Research University
Sponsor Class
Research institution
Responsible Party
Principal Investigator
Principal Investigator

Dr Sapna Dhiman PT

Delhi Pharmaceutical Sciences and Research University

Study Sites (1)

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