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

Infant, Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06109350
• Other study ID #: IRB/Approval/PN/2023/002/564
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: JDWNRH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 34 Weeks

Eligibility

Inclusion Criteria:

• Infants born between 28 -34 weeks of gestation

• Medically stable and off ventilator at the time of discharge from the hospital

• Parents who consent to come for follow up

Exclusion Criteria:

• Cortical blindness or retinopathy of prematurity causing blindness

• Musculoskeletal/congenital abnormalities

• Brain injuries including intra-ventricular hemorrhage (grade 3 and above), hypoxic ischemic encephalopathy and hydrocephalus

• Genetic syndrome

• Family who do not consent

• Parent with physical and psychological problems

• Infants with medical devices such as NG tube and gastrostomy

• Infants who have undergone major surgery

Related Conditions & MeSH terms

• Infant, Premature

Intervention

Other:
• Supporting play exploration and early developmental intervention(SPEEDI)
SPEEDI will be performed by the parents
• Standard care
Standard care will be performed by the parents

Locations

Country	Name	City	State
Bhutan	Jigme Dorji Wangchuck National Referral Hospital(JDWNRH)	Thimphu

Sponsors (1)

Lead Sponsor	Collaborator
JDWNRH

Country where clinical trial is conducted

Bhutan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare the compliance of the parents	Parental compliance will be measured by the ability of the parent to correctly demonstrate the home program activity when they come for follow up visit .	1, 2, and 3 months
Primary	Compare the motor performance using Test for Infant Motor Performance(TIMP)	TIMP is a validated tool to measure the motor performance from 34 weeks post menstrual age through 4 months corrected age. The 42 items on the test provides comprehensive assessment of head and trunk control and arms and legs movement. The total score of TIMP ranges from 0-142 with higher scores representing better motor outcome and lower score representing motor delay.	40 weeks, 1, 2, and 3 months of corrected age
Secondary	Compare the neurodevelopment using Rapid Neurodevelopment Assessment(RNDA)	RNDA is a validated tool to assess the neurodevelopment from birth to 2 years. It used to assess developmental domains such as primitive reflex, gross motor, fine motor, vision, hearing, speech, cognition and behavior. The assessment can be interpreted into four categories which are no, mild, moderate and severe impairment.	40 weeks, 1, 2, and 3 months of corrected age