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

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.'

Time frame: up to 24-months

Population: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).

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.

Time frame: up to 24-months

Population: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).

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.

Time frame: up to 24-months

Population: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).

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.

Time frame: up to 24-months

Population: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).

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.

Time frame: up to 24-months

Population: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).

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.

Time frame: up to 24-months

Population: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).

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.

Time frame: up to 24-months

Population: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow.

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.

Time frame: up to 24-months

Population: The available N for 6MWT at 12M (highest #) is represented under Overall # Analyzed. For each time point, there are 2 rows for age. Of the available N at each time point (see Participant Flow), the Walk Test was given only to GMFCS Level I, II, or III age 3yrs+. The 1MWT was given to a smaller subset of children in the Physical Activity Sub-Study.

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.

Time frame: up to 24-months

Population: The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).

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.

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)

Population: 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.

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)

Population: 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 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.

Time frame: Baseline

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.

Time frame: up to 24-months

Population: The 1MPT and 6MPT were administered for exploratory purposes in the Physical Activity Measurement sub-study. The available N at each time point = 5 children or fewer. Not every child was tested at every time point.

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.

Time frame: up to 24-months

Population: This test was administered for exploratory purposes in the Physical Activity Measurement sub-study. The available N at each time point is 4 or fewer. Also there are two age levels reported at each assessment time and children fell into only one of the two age groups.

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.

Time frame: up to 24-months

Population: Caregiver PEM-CY data was collected on a subset of 79 children who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).

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.

Time frame: up to 24-months

Population: Actigraph data was collected on a subset of 79 children who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).

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.

Time frame: up to 24-months

Population: Actigraph data was collected on a subset of 79 children who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).

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.

Time frame: up to 24-months

Population: StepWatch data was collected on a subset of 50 children in GMFCS Level I, II or II who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).

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.

Time frame: up to 24-months

Population: StepWatch data was collected on a subset of 50 children in GMFCS Level I, II or II who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).