NCT06109350

The Effect of Physical Therapy Intervention on Motor Performance in Bhutanese Preterm Infants

The Effect of Modified Supporting Play, Exploration and Early Development on Motor Performance in Bhutanese Preterm Infants- Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: JDWNRH · Academic / Other
• Sex: All
• Age: 28 Weeks – 34 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this randomized controlled trial is to assess if physical therapy intervention works well to improve motor performance in Bhutanese preterm infants.The main question the study aims to answer is: Will physical therapy intervention improve the motor performance of preterm infants at 3 months of corrected age when compared to the preterm infants receiving standard care of parental education? In this study the motor performance of the preterm infants receiving physical therapy intervention and standard care will be compared.

Detailed description

After receiving parental consent, preterm infants meeting the eligibility criteria will be enrolled for the study. 28 preterm infants will be enrolled and followed up from 40 weeks till 3 months of corrected age. The preterm infants in the intervention group will receive modified supporting play, exploration and early development intervention(SPEEDI) and the standard group will receive standard care. The intervention for both groups will be provided by the physical therapists. The SPEEDI intervention should be carried out by the parent for at least 20mins/day for 5 days in a week. The parent will be asked to bring the infants for monthly follow up. The motor performance of the preterm infants from this two groups will be assessed at 40 weeks, 1, 2 and 3 months of corrected age. The measurement tool that will be used to assess the preterm infants are Test for Infant Motor Performance(TIMP) and Rapid Neurodevelopment Assessment(RNDA). The assessment will be performed by therapist who will be blinded to the group allocation. The end point of the study is at 3 months of corrected age.

Conditions

• Infant, Premature

Interventions

Type	Name	Description
OTHER	Supporting play exploration and early developmental intervention(SPEEDI)	SPEEDI will be performed by the parents
OTHER	Standard care	Standard care will be performed by the parents

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2023-10-31
• Last updated: 2023-10-31

Locations

1 site across 1 country: Bhutan