Movement-based Infant Intervention

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT03082313
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 27.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The objective is to pilot test the effectiveness of an evidence-based intervention to promote positive neurodevelopmental outcomes in infants at risk for developmental delay. The intervention promotes movement experience from 3 months to sitting onset.

Condition or Disease	Intervention/Treatment	Phase
Infant Development; Infant,Premature; Infant, Very Low Birth Weight; Infant, Small for Gestational Age; Infant Conditions	Behavioral: Movement Intervention	N/A

Detailed Description

Aim: Our purpose was to assess daily leg movement rate before and after a caregiver-provided in-home intervention for infants at risk for developmental disability. We also assessed adherence and quality of caregiver-child interaction.

Methods: Twelve infants, at risk for developmental disabilities, and their caregivers participated in an intervention focused on increasing leg movements. Intervention started between 3- and 6-months cor- rected age and ended once the infant was able to sit independently or at 9 months corrected age, whichever occurred first. Infants were assessed monthly.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Movement-based Intervention to Promote Positive Neurodevelopmental Outcomes in Infants at Risk for Developmental Delay
• Actual Study Start Date: Sep 1, 2017
• Actual Primary Completion Date: Dec 17, 2019
• Actual Study Completion Date: Dec 17, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Movement intervention The intervention promotes movement experience from 3 months to sitting onset in infants at risk for developmental delay (AR). The goal of the intervention is to increase amount and type of infant leg movement experience above 1200 movements per hour of awake time.

Behavioral: Movement Intervention; At each visit, the caregiver will be reminded of the infant's movement rate from the last visit. The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time. Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant. The intervention will be based upon the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care.

Outcome Measures

Primary Outcome Measures

1. Movement Rate [post intervention (intervention duration ranged from 2-6 months)]

   leg movements produced per hour of awake time, assessed using wearable sensors

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 9 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Infants will be 3 months of adjusted age at the first visit, +/- 10 days. Infants will be defined as at risk if they qualify for high risk infant follow up care as defined by California Children's Services.

Exclusion Criteria:

• Infants with congenital malformations of the legs will be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Infant Neuromotor Control Laboratory	Los Angeles	California	United States	90089

Sponsors and Collaborators

• University of Southern California

Investigators

• Principal Investigator: Beth A Smith, PT, PhD, University of Southern California

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 10, 2018

More Information

Publications

None provided.

• Responsible Party: Beth A. Smith, Assistant Professor of Research, University of Southern California
• ClinicalTrials.gov Identifier: NCT03082313
• Other Study ID Numbers: HS-16-00959
• First Posted: Mar 17, 2017
• Last Update Posted: Apr 5, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Beth A. Smith, Assistant Professor of Research, University of Southern California: infant; leg movement; wearable sensors; early intervention
• Additional relevant MeSH terms: Birth Weight

Study Results

Participant Flow

Arm/Group Title	Movement Intervention
Arm/Group Description	The intervention promotes movement experience from 3 months to sitting onset in infants at risk for developmental delay (AR). The goal of the intervention is to increase amount and type of infant leg movement experience above 1200 movements per hour of awake time. Movement Intervention: At each visit, the caregiver will be reminded of the infant's movement rate from the last visit. The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time. Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant. The intervention will be based upon the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care.
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Movement Intervention
Arm/Group Description	The intervention promotes movement experience from 3 months to sitting onset in infants at risk for developmental delay (AR). The goal of the intervention is to increase amount and type of infant leg movement experience above 1200 movements per hour of awake time. Movement Intervention: At each visit, the caregiver will be reminded of the infant's movement rate from the last visit. The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time. Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant. The intervention will be based upon the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care.
Overall Participants	12
Age (Count of Participants)
<=18 years	12 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	4 33.3%
Male	8 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 75%
Not Hispanic or Latino	3 25%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 8.3%
Asian	1 8.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	4 33.3%
More than one race	0 0%
Unknown or Not Reported	6 50%
Region of Enrollment (participants) [Number]
United States	12 100%
leg movement rate (average leg movements per hour awake) [Median (Full Range) ]
Median (Full Range) [average leg movements per hour awake]	1294

Outcome Measures

1. Primary Outcome

Title	Movement Rate
Description	leg movements produced per hour of awake time, assessed using wearable sensors
Time Frame	post intervention (intervention duration ranged from 2-6 months)

Outcome Measure Data

Analysis Population Description

all infants enrolled in the study

Arm/Group Title	Movement Intervention
Arm/Group Description	The intervention promotes movement experience from 3 months to sitting onset in infants at risk for developmental delay (AR). The goal of the intervention is to increase amount and type of infant leg movement experience above 1200 movements per hour of awake time. Movement Intervention: At each visit, the caregiver will be reminded of the infant's movement rate from the last visit. The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time. Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant. The intervention will be based upon the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care.
Measure Participants	12
Median (Full Range) [average leg movements per hour awake]	1278

Adverse Events

Time Frame	across the duration of each infants' participation (range 2-6 months)
Arm/Group Title	Movement Intervention
Arm/Group Description	The intervention promotes movement experience from 3 months to sitting onset in infants at risk for developmental delay (AR). The goal of the intervention is to increase amount and type of infant leg movement experience above 1200 movements per hour of awake time. Movement Intervention: At each visit, the caregiver will be reminded of the infant's movement rate from the last visit. The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time. Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant. The intervention will be based upon the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care.
All Cause Mortality
	Movement Intervention
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	Movement Intervention
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Movement Intervention
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.