Trial Outcomes & Findings for Efficacy of the START-Play Program for Infants With Neuromotor Disorders (NCT NCT02593825)
NCT ID: NCT02593825
Last Updated: 2024-03-18
Results Overview
Bayley Scales of Infant Development III, cognitive scale; raw scores used to reflect change over time and absolute growth (rather than standard scores) Range: Minimum =20 points; Maximum=60 Higher score = better outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
Baseline, at end of 3 month intervention, and at 12 months post-baseline
Results posted on
2024-03-18
Participant Flow
Participant milestones
| Measure |
START-Play Intervention
Intervention incorporating cognitive factors \& focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.
START-Play intervention: The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill; the focus is not on a "normal
|
Business as Usual
Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.
Business as usual: May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
|
|---|---|---|
|
Intervention
STARTED
|
67
|
67
|
|
Intervention
COMPLETED
|
57
|
55
|
|
Intervention
NOT COMPLETED
|
10
|
12
|
|
Follow-up
STARTED
|
57
|
55
|
|
Follow-up
COMPLETED
|
57
|
55
|
|
Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
START-Play Intervention
Intervention incorporating cognitive factors \& focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.
START-Play intervention: The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill; the focus is not on a "normal
|
Business as Usual
Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.
Business as usual: May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
|
|---|---|---|
|
Intervention
Lost to Follow-up
|
10
|
12
|
Baseline Characteristics
Efficacy of the START-Play Program for Infants With Neuromotor Disorders
Baseline characteristics by cohort
| Measure |
START-Play
n=57 Participants
Received the START-Play intervention in addition to their usual early intervention and care
|
Business-as-Usual
n=55 Participants
Received only the usual early intervention and services required due to delays
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Months of age (adjusted for prematurity)
|
10.93 Months
STANDARD_DEVIATION 2.63 • n=5 Participants
|
10.67 Months
STANDARD_DEVIATION 2.57 • n=7 Participants
|
10.8 Months
STANDARD_DEVIATION 2.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Bayley Scales of Infant Development III, Cognitive
|
29.25 units on a scale
STANDARD_DEVIATION 7.14 • n=5 Participants
|
28.4 units on a scale
STANDARD_DEVIATION 6.45 • n=7 Participants
|
28.83 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, at end of 3 month intervention, and at 12 months post-baselinePopulation: All assessments were video recorded and stored for later scoring by researchers masked to group assignment.
Bayley Scales of Infant Development III, cognitive scale; raw scores used to reflect change over time and absolute growth (rather than standard scores) Range: Minimum =20 points; Maximum=60 Higher score = better outcome
Outcome measures
| Measure |
START-Play Intervention
n=57 Participants
Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.
START-Play intervention: The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.
|
Business as Usual
n=55 Participants
Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.
Business as usual: May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
|
|---|---|---|
|
Bayley Scales of Infant Development III
Full group, 3 mo results
|
35.9 score on a scale
Standard Deviation 7.2
|
33.6 score on a scale
Standard Deviation 7.1
|
|
Bayley Scales of Infant Development III
Severely delayed, 3 mo results
|
31.7 score on a scale
Standard Deviation 7.7
|
29.4 score on a scale
Standard Deviation 6.4
|
|
Bayley Scales of Infant Development III
Mildly delayed, 3 mo
|
39.3 score on a scale
Standard Deviation 4.6
|
37.3 score on a scale
Standard Deviation 5.4
|
|
Bayley Scales of Infant Development III
Full group, 12 mo results
|
44.63 score on a scale
Standard Deviation 12.23
|
43.28 score on a scale
Standard Deviation 12.05
|
|
Bayley Scales of Infant Development III
severly delayed, 12 month
|
36.6 score on a scale
Standard Deviation 10.94
|
35.11 score on a scale
Standard Deviation 10.37
|
|
Bayley Scales of Infant Development III
mildly delayed, 12 mo
|
52 score on a scale
Standard Deviation 8.06
|
49.95 score on a scale
Standard Deviation 8.87
|
SECONDARY outcome
Timeframe: Baseline, at end of 3 month intervention, and at 6 and 12 months after baselinePopulation: caregiver and infants with motor delays
Play and interaction of parent and child, coding of behavior frequency and type of interaction; coded as a total percentage of time the parent provided cognitive opportunities
Outcome measures
| Measure |
START-Play Intervention
n=57 Participants
Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.
START-Play intervention: The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.
|
Business as Usual
n=55 Participants
Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.
Business as usual: May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
|
|---|---|---|
|
Change in Modified Parent Child Interaction-Dyadic Mini Code
Baseline
|
.22 percentage of time
Standard Deviation .26
|
.19 percentage of time
Standard Deviation .22
|
|
Change in Modified Parent Child Interaction-Dyadic Mini Code
3 months post baseline
|
.46 percentage of time
Standard Deviation .32
|
.34 percentage of time
Standard Deviation .31
|
|
Change in Modified Parent Child Interaction-Dyadic Mini Code
6 months post baseline
|
.49 percentage of time
Standard Deviation .32
|
.46 percentage of time
Standard Deviation .32
|
|
Change in Modified Parent Child Interaction-Dyadic Mini Code
12 months post baseline
|
.65 percentage of time
Standard Deviation .31
|
.62 percentage of time
Standard Deviation .30
|
SECONDARY outcome
Timeframe: Baseline, at end of 3 month intervention, and at 12 months after baselinePopulation: Compared full group pre and post intervention, and then sub-groups of mild and severe Also examined these groups in sub-groups of mildly delayed (\<2.5 Standard Deviations below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5SD below the mean on motor Bayley score at baseline)
behavioral coding of play and hand use, coded from videotape; Coding software used to time contacts during standard reaching task during 5 minute reaching at shoulder level and below.
Outcome measures
| Measure |
START-Play Intervention
n=57 Participants
Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.
START-Play intervention: The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.
|
Business as Usual
n=55 Participants
Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.
Business as usual: May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
|
|---|---|---|
|
Change in Frequency (Number) of Toy Contacts
Full group, 3 mo results
|
13.1 occurrences
Standard Deviation 8.7
|
13 occurrences
Standard Deviation 7.9
|
|
Change in Frequency (Number) of Toy Contacts
Severely delayed, 3 mo results
|
7.2 occurrences
Standard Deviation 4.8
|
9.3 occurrences
Standard Deviation 7.5
|
|
Change in Frequency (Number) of Toy Contacts
Mildly delayed, 3 mo
|
18.2 occurrences
Standard Deviation 8
|
16.5 occurrences
Standard Deviation 6.7
|
|
Change in Frequency (Number) of Toy Contacts
Full group, 12 months
|
16.46 occurrences
Standard Deviation 9.48
|
15.03 occurrences
Standard Deviation 8.93
|
|
Change in Frequency (Number) of Toy Contacts
severly delayed, 12 month
|
13.64 occurrences
Standard Deviation 10.98
|
9.78 occurrences
Standard Deviation 7.26
|
|
Change in Frequency (Number) of Toy Contacts
mildly delayed, 12 months
|
19.43 occurrences
Standard Deviation 6.65
|
20.28 occurrences
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Baseline, at end of 3 month intervention, and at 12 months after baselinecoding number seconds of videotaped hand use during play; timing coded in a video coding software for behavioral analysis Higher score=better
Outcome measures
| Measure |
START-Play Intervention
n=57 Participants
Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.
START-Play intervention: The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.
|
Business as Usual
n=55 Participants
Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.
Business as usual: May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
|
|---|---|---|
|
Change in Duration (Time) of Toy Contacts
Baseline
|
38.20 seconds
Standard Deviation 30.88
|
42.28 seconds
Standard Deviation 30.70
|
|
Change in Duration (Time) of Toy Contacts
3 months post baseline
|
44.93 seconds
Standard Deviation 29.84
|
47.38 seconds
Standard Deviation 28.88
|
|
Change in Duration (Time) of Toy Contacts
12 months post baseline
|
46.87 seconds
Standard Deviation 28.25
|
44.35 seconds
Standard Deviation 26.36
|
SECONDARY outcome
Timeframe: Baseline, at end of 3 month intervention, and at 12 months after baselinePopulation: Analyzed full group, and separately the mildly delayed group and the significantly delayed group
Gross motor skills in the sitting subsection of the Gross Motor Function Measure (GMFM) Minimum value=4 Maximum value=60 Higher scores=better outcome
Outcome measures
| Measure |
START-Play Intervention
n=57 Participants
Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.
START-Play intervention: The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.
|
Business as Usual
n=55 Participants
Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.
Business as usual: May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
|
|---|---|---|
|
Change in Gross Motor Function Measure, Sitting Subscale
Full group, 3 mo results
|
35 score on a scale
Standard Deviation 14.2
|
31.3 score on a scale
Standard Deviation 14.7
|
|
Change in Gross Motor Function Measure, Sitting Subscale
Severely delayed, 3 mo results
|
26.3 score on a scale
Standard Deviation 13
|
20.9 score on a scale
Standard Deviation 9.5
|
|
Change in Gross Motor Function Measure, Sitting Subscale
Mildly delayed, 3 mo
|
41.9 score on a scale
Standard Deviation 10.9
|
40.6 score on a scale
Standard Deviation 12.1
|
|
Change in Gross Motor Function Measure, Sitting Subscale
Full group, 12 mo results
|
47.13 score on a scale
Standard Deviation 15.95
|
44.88 score on a scale
Standard Deviation 17.54
|
|
Change in Gross Motor Function Measure, Sitting Subscale
severely delayed, 12 month
|
38.26 score on a scale
Standard Deviation 18.37
|
32.72 score on a scale
Standard Deviation 19.72
|
|
Change in Gross Motor Function Measure, Sitting Subscale
mildly delayed, 12 mo
|
55.28 score on a scale
Standard Deviation 6.63
|
54.39 score on a scale
Standard Deviation 6.58
|
SECONDARY outcome
Timeframe: Baseline, at end of 3 month intervention, and at 6 and 12 months after baselinePopulation: Compared full group and also sub-groups of mild or severely delayed children separately
Infant growth and development indicator of problem solving skills, adapted for children with motor deficits Modified to Assessment of Problem-Solving in Play (APSP) Minimum=30 Maximum=120 Higher=better outcome
Outcome measures
| Measure |
START-Play Intervention
n=57 Participants
Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.
START-Play intervention: The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.
|
Business as Usual
n=55 Participants
Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.
Business as usual: May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
|
|---|---|---|
|
Change in Early Problem Solving Indicator (EPSI)
Full group, 3 mo results
|
64.5 score on a scale
Standard Deviation 27.9
|
59.2 score on a scale
Standard Deviation 30.4
|
|
Change in Early Problem Solving Indicator (EPSI)
Severely delayed, 3 mo results
|
57.7 score on a scale
Standard Deviation 31.1
|
46.9 score on a scale
Standard Deviation 30.9
|
|
Change in Early Problem Solving Indicator (EPSI)
Mildly delayed, 3 mo
|
70 score on a scale
Standard Deviation 24.3
|
70.2 score on a scale
Standard Deviation 25.9
|
|
Change in Early Problem Solving Indicator (EPSI)
Full group, 12 mo results
|
90.71 score on a scale
Standard Deviation 42.66
|
81.95 score on a scale
Standard Deviation 41.92
|
|
Change in Early Problem Solving Indicator (EPSI)
severely delayed, 12 month
|
71.98 score on a scale
Standard Deviation 41.6
|
61.92 score on a scale
Standard Deviation 42.67
|
|
Change in Early Problem Solving Indicator (EPSI)
mildly delayed, 12 mo
|
107.95 score on a scale
Standard Deviation 36.5
|
97.63 score on a scale
Standard Deviation 34.68
|
SECONDARY outcome
Timeframe: Baseline, at end of 3 month intervention, and at 12 months after baselinePopulation: infants with severe motor delays
Looking while contacting toy, frequency of either unimanual or bimanual contact while looking at toy
Outcome measures
| Measure |
START-Play Intervention
n=25 Participants
Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.
START-Play intervention: The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.
|
Business as Usual
n=25 Participants
Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.
Business as usual: May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
|
|---|---|---|
|
Change in Reaching (Change in Looking and Hand Contact of Toy)
Baseline
|
4.06 occurrences
Standard Deviation .88
|
5.96 occurrences
Standard Deviation 1.81
|
|
Change in Reaching (Change in Looking and Hand Contact of Toy)
12 months post baseline
|
10.83 occurrences
Standard Deviation 1.99
|
7.69 occurrences
Standard Deviation 2.56
|
|
Change in Reaching (Change in Looking and Hand Contact of Toy)
3 months post baseline
|
7.45 occurrences
Standard Deviation 1.21
|
7.14 occurrences
Standard Deviation 1.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change over 3 monthsPopulation: Infants with severe delays
Angle of forward trunk lean in sitting position
Outcome measures
| Measure |
START-Play Intervention
n=25 Participants
Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.
START-Play intervention: The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.
|
Business as Usual
n=25 Participants
Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.
Business as usual: May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
|
|---|---|---|
|
Change in Postural Measure of Trunk Angle
|
10.93 degrees
Standard Deviation 10.93
|
11.64 degrees
Standard Deviation 8.23
|
Adverse Events
START-Play
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Business-as-Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Regina Harbourne, Primary Investigator
Duquesne University
Phone: 4026570538
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place