On Track: Monitoring Development of Children With Cerebral Palsy or Gross Motor Delay
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|ClinicalTrials.gov Identifier: NCT02391948|
Recruitment Status : Completed
First Posted : March 18, 2015
Results First Posted : April 19, 2019
Last Update Posted : April 19, 2019
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.
|Condition or disease|
Trained therapist assessors will measure the primary and secondary impairments (i.e., balance, range of motion limitations, and strength) on 5 occasions (6-months apart over 2 years). Parents will complete questionnaires to track changes in the child's endurance, health conditions, and participation in self-care and recreation activities, at the same data collection points. The researchers will use these 5 data collection points to develop reference percentiles and will present the data so that therapists can assist families to determine if children with CP are developing as expected, better than expected, or more poorly than expected, depending on their functional ability levels.
The researchers will create longitudinal developmental curves for impairments, health conditions, and participation variables by estimating the average pattern of change, important individual variations in the pattern of change between children, and the degree of consistency over time within children. Establishment of longitudinal developmental curves will provide easily understood and useful tools for families and service providers to discuss questions about how well their children are doing in relationship to other children with CP of similar functional ability levels. The researchers will then utilize service data collected from parents and children's progress on the longitudinal developmental curves to develop recommendations for rehabilitation service provision for children with CP across functional ability levels. Having this information should assist with collaborative decision-making among family members and service providers that efficiently utilizes rehabilitation services to meet families' goals.
An additional sub-study is to collect direct physical activity measurements from a sub-set of the children in the larger study. These data will be examined in relationship to other measures of endurance and participation.
|Study Type :||Observational|
|Actual Enrollment :||724 participants|
|Official Title:||Developmental Trajectories of Impairments, Health, and Participation of Children With Cerebral Palsy|
|Actual Study Start Date :||July 1, 2013|
|Actual Primary Completion Date :||August 31, 2016|
|Actual Study Completion Date :||March 31, 2017|
- Early Clinical Assessment of Balance (ECAB) [ Time Frame: up to 24-months ]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.
- Spinal Alignment and Range of Motion Measure (SAROMM) [ Time Frame: up to 24-months ]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.
- Functional Strength Assessment (FSA) [ Time Frame: up to 24-months ]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.
- Six and One-minute Walk Test (6MWT, 1MWT) [ Time Frame: up to 24-months ]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.
- Early Activity Scale for Endurance (EASE) [ Time Frame: up to 24-months ]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.
- Child Health Conditions Questionnaire [ Time Frame: up to 24-months ]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.
- Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation [ Time Frame: up to 24-months ]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.'
- Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care [ Time Frame: up to 24-months ]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.
- Services Questionnaire [ Time Frame: up to 24-months ]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.
- Percentage of All Participants According to Gross Motor Function Classification System (GMFCS) [ Time Frame: Baseline ]The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations; II: Walks with limitations; III: Walks using a hand-held mobility device; IV: Self-mobility with limitations; may use powered mobility; and V: Transported in manual wheelchair. Descriptors for the five levels vary by age of the child. Children were classified by consensus between parents and assessing therapists by comparing the child's functional movement ability to descriptors for each level of classification.
- Manual Ability Classification System (MACS) [ Time Frame: Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline) ]The MACS is a classification system based on functional hand movement ability. MACS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions for each level are: I: Handles objects easily & effectively; II: Handles most objects with somewhat reduced quality and/or speed; III: Handles objects with difficulty, needs help to prepare and/or modify activities; IV: Handles a limited selection of easily managed objects; and V: Does not handle objects and has severely limited ability to perform even simple actions.
- Communication Function Classification System (CFCS) [ Time Frame: Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline) ]The CFCS is a classification system based on functional communication ability. CFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions for each level are: I: Effective sender/receiver with familiar/unfamiliar partners; II: Effective but slower paced sender and/or receiver with familiar/unfamiliar partners; III: Effective sender & receiver with familiar partners; IV: Inconsistent sender and/or receiver with familiar partners; and V: Seldom effective sender & receiver with familiar partners.
- Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides) [ Time Frame: up to 24-months ]For participants who were ambulatory (GMFCS levels I, II, III), walking activity performance was measured within the context of daily life with a monitor called the StepWatch. It is a small (70 x 50 x 20 mm; 38 g), waterproof, self-contained device that is worn on the left ankle. Participants wore the StepWatch on their ankle (inside a knit cuff) each day for a seven-day sample. Specific variables reported are an intensity measure, average number of strides per day faster than 30 per minute (moderate to high intensity strides) for the seven-day sample.
- Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day [ Time Frame: up to 24-months ]For participants who were ambulatory (GMFCS levels I, II, III), walking activity performance was measured within the context of daily life with a monitor called the StepWatch. It is a small (70 x 50 x 20 mm; 38 g), waterproof, self-contained device that is worn on the left ankle. Participants wore the StepWatch on their ankle (inside a knit cuff) each day for a seven-day sample. Specific variables reported are an an amount measure, average number of single leg strides per day for the seven-day sample.
- Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity [ Time Frame: up to 24-months ]Participants wore a 3-dimensional accelerometer (Actigraph wGT3X) on their dominant wrist for a seven-day sample. Specific variables reported are number of minutes time spent in moderate/vigorous physical activity for a seven-day sample. The wrist mounted Actigraph counts were converted to waist worn activity counts.
- Physical Activity Measurement: Actigraph: Average Physical Activity [ Time Frame: up to 24-months ]Participants wore a 3-dimensional accelerometer (Actigraph wGT3X) on their dominant wrist for a seven-day sample. Specific variables reported are average physical activity in raw activity counts per minute for a seven-day sample. The wrist mounted Actigraph counts were converted to waist worn activity counts.
- 1 Minute to 6 Minute Push Test (1MPT, 6MPT) [ Time Frame: up to 24-months ]The 1MPT to 6MPT are submaximal, clinical exercise tests, in which the total distance propelled in a manual wheelchair in 1-minute and 6-minutes, under controlled conditions, are measured for children who use a manual wheelchair for mobility (GMFCS level II, III, IV), the 1MPT/6MPT was conducted indoors or outdoors on a large, flat, hard terrain. A surveyor's measure wheel was used to calculate the total distance wheeled and a stopwatch to keep track of the allocated time. Standardized directions were used to encourage the child to wheel as far as possible. Distances wheeled (# of feet) are reported for a small number of participants within the Physical Activity sub-study.
- 1 Stroke Push Test (1SPT) [ Time Frame: up to 24-months ]The 1SPT is a clinical exercise test, in which the distance rolled in a manual wheelchair, under controlled conditions, with one push using both hands if possible is measured. Within this study a subsample of children who used a manual wheelchair for mobility (GMFCS levels III, IV) were tested on this measure. A surveyor's measure wheel will be used to calculate the total distance (# of feet) wheeled. Standardized directions are used to encourage the child to wheel as far as possible.
- Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY) [ Time Frame: up to 24-months ]The PEM-CY environment section is a caregiver completed 45-item questionnaire about the facilitators and barriers that might impact the child's participation in the home, school, and community environments. Twenty-five items include ratings on things that help or make it harder for the child to participate in activities in each environment (4-point scale from "not an issue" to "usually makes harder"). Twenty items include ratings of the availability of supports for the child's participation in each environment (4-point scale from "not needed" to "usually no"). Caregivers can also write in what family members do that help the child participate. A percentage score representing support for participation for each setting is calculated. The higher the percentage the more support the environment provides for the child's participation within the setting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391948
|United States, Georgia|
|Atlanta, Georgia, United States, 30341|
|United States, Oklahoma|
|University of Oklahoma|
|Oklahoma City, Oklahoma, United States, 73117|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19102|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|University of Western Ontario|
|London, Ontario, Canada, N6G 1H1|
|Principal Investigator:||Sarah Westcott McCoy, PhD, PT||University of Washington|