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Clinical Trials/CTRI/2024/02/063303
CTRI/2024/02/063303
Not yet recruiting
Phase 1

Effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation Techniques along with Virtual Game-based rehabilitation on overall balance in children with Spastic Diplegia-A Randomized Controlled Trial

NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India1 site in 1 country36 target enrollmentStarted: April 1, 2024Last updated:

Overview

Phase
Phase 1
Status
Not yet recruiting
Sponsor
NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
Enrollment
36
Locations
1
Primary Endpoint
1. Pelvic asymmetry through Palpation Meter Device (PALM)

Overview

Brief Summary

Aim of the study is to evaluate the effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation Techniques along with Exergaming based rehabilitation on static active and reactive sitting balance in children with Spastic CP. Primary Objective is to evaluate the effect of Pelvic Proprioceptive Neuromuscular Facilitation along with exergaming-based rehabilitation through Wii Fit on overall sitting balance in children with Spastic CP. To compare the effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation along with exergaming-based rehabilitation with conventional therapy on overall sitting balance in children with Spastic CP. Secondary Objective is toevaluate the effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation on pelvic asymmetry in children with Spastic CP. Scope of the study is Pelvic Proprioceptive Neuromuscular Facilitation along with game based rehabilitation can be an effective technique of rehabilitation in spastic CP children to improve their balance by targeting trunk control by effective Pelvic PNF and also game based rehabilitation in static, active and reactive balance training. Clinical implication of the study is, if the study is proved to be effective then training of pelvic control will become an active ingredient in treatment of children with cerebral palsy to improve static, active and reactive balance. Novelty:

Game based rehabilitation along with pelvic PNF will add additional benefits in Paediatric physiotherapy OPD and also in community rehabilitation setup. It adds to quality time spend by children in physiotherapy.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
4.00 Year(s) to 9.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Children diagnosed with Spastic CP of either gender 2) Children from 4 to 9 years of age 3) Children with pelvic asymmetry 4) Children with Gross Motor Functional Classification System level I to III 5) Children who can and cannot Sit Independently 6) Children who are able to follow commands (Pediatric MMSE greater than or equal to 22).

Exclusion Criteria

  • Children under botox medication in the last 6 months 2) Children who underwent any surgery involving spine and in past 6 months 3) Children having uncontrolled seizures since past 6 months 4) Children with fixed deformities or contractures in spine.

Outcomes

Primary Outcomes

1. Pelvic asymmetry through Palpation Meter Device (PALM)

Time Frame: On the day 1 and at the end of 6 weeks(Last day of 6th week)

2. Balance through Pediatric Balance Scale

Time Frame: On the day 1 and at the end of 6 weeks(Last day of 6th week)

3. trunk control through Segmental assessment of trunk control

Time Frame: On the day 1 and at the end of 6 weeks(Last day of 6th week)

4. Gross motor function through Gross Motor Function Measure GMFM-88

Time Frame: On the day 1 and at the end of 6 weeks(Last day of 6th week)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India
Sponsor Class
Other [Constituent Physiotherapy Institute of NITTE(Deemed to be University)]
Responsible Party
Principal Investigator
Principal Investigator

Dr Rakesh Krishna Kovela

Nitte Institute of Physiotherapy, NITTE(Deemed to be University).

Study Sites (1)

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