Early exposure to toy on motor development in high risk babies

Not yet recruiting

• Conditions: Pre-term infants

• Registration Number: CTRI/2022/01/039604
• Lead Sponsor: Mrunmayi Sandip Gadre

Brief Summary

This study is a randomized controlled trial to study the impact of early exposure to play materials on motor development in high risk infants. Baseline assessment will be taken by using PDMS-2 as an outcome measure. All the participants will be screened and recruited according to the inclusion and exclusion criteria. The sample size is total 36 which will be divided into 2 groups, 18 in control group and 18 in experimental group. The intervention given to both the groups will be for 8 weeks. Post assessment will be done after 8 weeks using PDMS-2.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-01-19
• Study Start: 2022-01-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Infants in the corrected age of 5 months 0 day to 6 months 30 days.
• The parent-infant dyad is a permanent resident of Belagavi city.
• Both the genders Parents willing to participate in the study.

Exclusion Criteria

• History of or diagnosed with any birth defect or congenital abnormality.
• Recent surgeries in 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peabody Developmental Motor Scales -Second Edition (PDMS-2)	Baseline and after 6 weeks

Trial Locations

Locations (1)

KLES Dr. Prabhakar Kore hospital; 🇮🇳 Belgaum, KARNATAKA, India

KLES Dr. Prabhakar Kore hospital

🇮🇳Belgaum, KARNATAKA, India

Mrunmayi Gadre

Principal investigator

9822164497

gadremrunmayi477@gmail.com