On Track: Monitoring Development of Children With Cerebral Palsy or Gross Motor Delay

NCT02391948 | Completed Results

• 1 other identifier: 43611
• Study Type: observational
• Target: 724
• Locations: 2 countries
• Sites: 5

Brief Summary

The On Track Study is a large multi-site collaboration involving researchers, therapists, families, and children with cerebral palsy (CP) from across Canada and the United States. The researchers need to better understand how young children who have difficulties with movement activities progress and develop in their balance abilities, fitness, strength, health, range of motion, self-care, everyday play, and activity participation. This study will determine how young children with cerebral palsy or gross motor delays progress in many aspects of their physical development and participation in daily life. The information collected from this study will help therapists and parents monitor if a child is developing as expected in his or her physical development and participation. Then, the health care professionals working with children can use the results of this study, in combination with the previously completed Move \& PLAY study results, to provide the services that are most beneficial and meaningful for each child and their family members.

Conditions

Cerebral Palsy

Keywords

Cerebral palsy; Gross motor delay

Outcome Measures

Primary Outcomes (9)

• Early Clinical Assessment of Balance (ECAB)

  The ECAB addresses postural control and balance across the developmental sequence. Part I has 7 items (with numbers 1,4,5,6,7 scored bilaterally): 1) lateral head righting, 2) head righting in extension, 3) head righting in flexion, 4) rotation in the trunk, 5) equilibrium reactions in sitting, 6) protective extension to the side, and 7) protective extension backwards. The items are scored on a scale of 0 = no response to 3 = complete \& consistent response. Part II has 6 items: 1) sitting with back unsupported but feet supported, 2) moving from sitting to standing, 3) standing unsupported with eyes closed, 4) standing unsupported with feet together, 5) turning 360 degrees in standing unsupported, 6) placing alternate foot on the step while standing unsupported. These items are scored on a variable scale, which is weighted due to the increased difficulty of the items. Part I and Part II item scores are summed for a total score between 0-100. A higher score represents better balance.

  up to 24-months

• Spinal Alignment and Range of Motion Measure (SAROMM)

  The SAROMM addresses joint range of motion, extensibility, and spinal alignment. The Spinal Alignment Subscale contains 4 items and the Range of Motion and Extensibility Subscale has 22 items. Each item is scored on a 5-point Likert scale, with 0 = normal alignment and range with active correction, 1 = normal alignment and range with passive correction, and 2, 3, and 4 indicating fixed deformities or contractures that are "mild", "moderate", or "severe" based on pre-specified cut points, and supported by photographs in the training manual. Scores are reported by calculating the average of scores across all 26 items. Scores range from 0-4. A lower score represents better range of motion and alignment.

  up to 24-months

• Functional Strength Assessment (FSA)

  The FSA addresses force production ability in the neck and trunk flexor and extensor and bilateral hip and knee extensor and shoulder flexor muscle groups. Each muscle group is rated on a five-point ordinal scale from 1 = only flicker of contraction or just initiates movement against gravity to 5 = full available range against gravity and strong resistance. Scores are reported by calculating the average of scores across all 8 items. Scores range from 1 to 5. A higher score represents better force production ability.

  up to 24-months

• Six and One-minute Walk Test (6MWT, 1MWT)

  The 6MWT and 1MWT are submaximal, clinical exercise tests, in which the total distance traveled in 1-minute and 6-minutes, under controlled conditions, are measured. Within this study, the 6MWT/1MWT was conducted indoors or outdoors on a large, flat, hard terrain for children who were 3 years or older and who were walking without another person's assistance (GMFCS I, II, III). A surveyor's measure wheel was used to calculate the total distance (# of feet) walked and a stopwatch to keep track of the allocated time. Standardized directions are used to encourage the child to walk as far as possible in the time.

  up to 24-months

• Early Activity Scale for Endurance (EASE)

  The EASE includes 4 activity-based items requiring parents to rate their children's levels of energy, the frequency and need for rest, and the average amount of time their children can engage in physical activity. Scoring for each item is on a Likert scale of 1-5 with the value of 1 = "Never" to 5 = "Always". The four questions include: 1) "my child's physical activity level is similar to other children his or her age," 2) "my child has a high physical energy level and rarely needs to take rests when moving himself or herself around during daily activities and play time," 3) "my child does enough activity so that he or she is breathing quickly or gets flushing in his or her face at least one time each day," and 4) "my child spends a lot of his or her play or free time doing activities that require lots of physical energy." Scores are reported by calculating the average across all 4 questions. Scores range from 1 to 5. A higher score represents better endurance for activity.

  up to 24-months

• Child Health Conditions Questionnaire

  The Child Health Conditions questionnaire is a caregiver-completed measure of the extent to which health problems influence children's activities. Parents respond "yes" or "no" as to whether the child has each of the 16 health problems listed. If the child does not have a problem, a score of 0 is imputed for the next part of the question. If the child has a problem, parents are asked to judge the extent to which the problem affects the child's daily activities. This is measured using an 8-point ordinal scale from 0="does not have the problem", 1= "not at all" to 7 = "to a very great extent". Scores reported are the Child Health Conditions Impact average scores calculated by averaging across all 16 items. Scores range form 0 to 7. A higher score represents a greater impact of health conditions on daily activities.

  up to 24-months

• Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation

  CEDL is a 40-item caregiver-completed questionnaire to estimate children's participation. Part 1 captures participation of the child in family/community and leisure/recreational activities. Part 1 is scored on two 5-point Likert scales: 1) how often a child participates (1=almost never to 4=very often), and 2) the degree of enjoyment (1=not at all to 5 a great deal). A Rasch analysis has converted scores into 0-100 scaled scores. A higher score represents a higher degree of 'leisure.'

  up to 24-months

• Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care

  CEDL is a 40-item caregiver-completed questionnaire to estimate children's participation. Part 2 measures self-care, defined as the degree that the child participates in daily feeding, dressing, bathing, and toileting. Part 2 is scored on a 5-point Likert scale from 1= 'does not do the activity' to 5= 'does the activity independently most of the time'. The scale distinguishes the need for physical assistance from a person, the ability to complete the activity under various conditions, and the amount of the activity able to complete. A Rasch analysis has converted scores into 0-100 scaled scores for both parts. A higher score represents a higher degree of self-care (Part 2) participation.

  up to 24-months

• Services Questionnaire

  The Services questionnaire is a caregiver-completed measure of the medical and rehabilitation services provided to the child in the period since the last data collection point. The variables used for the analysis of the relationship between services and four outcomes are reported. These data are: mean amount of physical, occupational, and speech and language therapy service sessions per year (recorded in 5 ordinal intensity times/year categories: 1=0-1, 2=2-30, 3=31-52, 4=53-155, 5=\>156), mean family centeredness across 14 items (scored in 5 ordinal categories: 1=not at all, 2=small, 3=moderate, 4=great, 5=very great extent), mean rating of parents' perceptions that services were meeting their children's needs (scored on ordinal scale 1=not at all, 2=small, 3=moderate, 4=great extent, 5=completely), mean rating of the extent to which therapy was focused into 8 categories (scored in same ordinal categories as family centeredness above). Higher scores indicate a great amount or extent.

  up to 24-months

Secondary Outcomes (3)

• Percentage of All Participants According to Gross Motor Function Classification System (GMFCS)

  Baseline

• Manual Ability Classification System (MACS)

  Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)

• Communication Function Classification System (CFCS)

  Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)

Other Outcomes (7)

• Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)

  up to 24-months

• Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day

  up to 24-months

• Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity

  up to 24-months

Eligibility Criteria

• Age: 18 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with cerebral palsy or gross motor delay and CP motor symptoms, ages 18 month to 12 years, and their parents.

You may qualify if:

• Families with a child who has a diagnosis of cerebral palsy or delayed motor development with muscle stiffness and difficulties with balance and moving.
• Certain geographical areas of Canada and the US.

You may not qualify if:

• Children will be excluded if they have: 1) Diagnosis other than cerebral palsy (such as autism, Down syndrome, spinal cord injury, acute head injury, muscle disorder, developmental syndrome, genetic disorder); 2) Gross motor delay without associated problems with muscle tone, balance, and active movement; 3) are wards of the state; and 4) Families who do not speak English, French, or Spanish will not be eligible to participate in this study.

Sponsors & Collaborators

• University of Washington: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (5)

Mercer University

Atlanta, Georgia, 30341, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73117, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Western Ontario

London, Ontario, N6G 1H1, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

This was a prospective observational cohort study not a randomized controlled trial. The Activity Performance sub-study included a smaller number of participants due to the extended week long data collection process.

Results Point of Contact

• Title: Sarah Westcott McCoy PT, PhD, FAPTA
• Organization: University of Washington

westcs@uw.edu

206-616-8601

Study Officials

• Sarah Westcott McCoy, PhD, PT

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Rehabilitation Medicine

Study Record Dates

• First Submitted: November 23, 2014
• First Posted: March 18, 2015
• Study Start: July 1, 2013
• Primary Completion: August 31, 2016
• Study Completion: March 31, 2017
• Last Updated: April 19, 2019
• Results First Posted: April 19, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); CA (1)