Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-28 @ 8:48 AM
Study NCT ID:
NCT06109350
Status:
UNKNOWN
Last Update Posted:
2023-10-31
First Post:
2023-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Physical Therapy Intervention on Motor Performance in Bhutanese Preterm Infants
Sponsor:
JDWNRH
Organization:
Study Overview
Official Title:
The Effect of Modified Supporting Play, Exploration and Early Development on Motor Performance in Bhutanese Preterm Infants- Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: