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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infant, Premature
• Intervention / Treatment: Other: Supporting play exploration and early developmental intervention(SPEEDI); Other: Standard care

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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bhutan
  • Thimphu, Bhutan, 11001
    • Jigme Dorji Wangchuck National Referral Hospital(JDWNRH)
    • Contact: Dinesh Pradhan, MD; Phone Number: +97517999472; Email: dinesh.bhutan@gmail.com
    • Principal Investigator: Karma Lhaki, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supporting play exploration and early development intervention; Preterm infants will receive supporting play exploration and early developmental intervention till 3 months of corrected age.	Other: Supporting play exploration and early developmental intervention(SPEEDI); SPEEDI will be performed by the parents
Active Comparator: Standard care; Preterm infants will receive standard care mostly including health education till 3 months of corrected age.	Other: Standard care; Standard care will be performed by the parents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: JDWNRH
• Investigators: Principal Investigator: Karma Lhaki, JDWNRH

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB/Approval/PN/2023/002/564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data will be shared after de identification
• IPD Sharing Time Frame: Data will be maintained securely for at least five years after completion of study and shared.
• IPD Sharing Access Criteria: To gain access to data, data requestor can email to principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No