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Trial record 4 of 16 for:    cerebral palsy | United States, Washington

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Sarah Westcott McCoy, University of Washington
ClinicalTrials.gov Identifier:
NCT02391948
First received: November 23, 2014
Last updated: December 2, 2015
Last verified: December 2015
  Purpose

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
Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developmental Trajectories of Impairments, Health, and Participation of Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Early Clinical Assessment of Balance (ECAB) [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    The ECAB addresses postural control and balance across the developmental sequence. Part I has 7 items: 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 scale of 0 = cannot do to 4 = fully completes, and then 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 ] [ Designated as safety issue: No ]
    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. The Spinal Alignment Subscale Score is obtained by summing the 4 items; the Range of Motion and Extensibility Subscale Score is obtained by summing the 22 items. A total SAROMM score is obtained by summing the two subscale scores with scores ranging from 0 to 104 or by taking the average score across all items. A lower score represents better range of motion and alignment.

  • Functional Strength Assessment (FSA) [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    The FSA addresses force production ability in the neck and trunk flexor and extensor and hip and knee extensor muscle groups and the shoulder flexor muscle group. 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 can be interpreted by calculating the average of scores across all items. A higher score represents better force production ability.

  • One to Six-minute Walk Test (1MWT, 6MWT) [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    The 1MWT to 6MWT are submaximal, clinical exercise tests, in which the total distance in meters travelled in 1-minute and 6-minutes, under controlled conditions, are measured. Within this study, the 1MWT/6MWT will be conducted indoors or outdoors on a large, flat, hard terrain. A surveyor's measure wheel will be used to calculate the total distance 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.

  • Early Activity Scale for Endurance (EASE) [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    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." The maximum total score is 20. A higher score represents better endurance for activity.

  • Health Conditions Questionnaire [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    The Health Conditions questionnaire is a caregiver-completed measure of the extent to which health problems influence children's activities. Parents respond "yes" or "no" to each health problem listed, and if the child has a problem, parents are asked to judge the effect of the problem on the child's daily life using an 8-point ordinal scale from 1= "not at all" to 7 = "to a very great extent". A score of 0 is imputed if the child does not have the problem. Both the number and average effect of the health problems on activity level are calculated as the summary scores. A higher score represents a greater number of health conditions and a greater effect on the children's activity.

  • Child Engagement in Daily Life Measure [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    This is a 40-item caregiver-completed questionnaire to estimate the child's participation. Part One captures interaction with others and play; specifically, participation of the child in family/community life and leisure/recreational activities. This domain is scored on two 5-point Likert scales: 1) how often a child participates (very often to never), and 2) the degree of enjoyment (a great deal to not at all). Part Two measures self-care, defined as the degree that the child participates in daily feeding, dressing, bathing, and toileting. The 5-point Likert ratings for self-care activities range from 'does the activity independently most of the time' to 'does not do the activity'. 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. Summary scores are average Likert scale scores for each part. A higher score represents a higher degree of participation.

  • Services Questionnaire [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    The Services questionnaire is a caregiver-completed measure of the medical and rehabilitation services provided to the child, as well as major medical and surgical interventions in the 6-month period preceding each data collection point. These data can be summarized across the study period as: number of primary care visits, number of medical service visits, number of medical and surgical procedures, amount of physical, occupational, and speech and language therapy services, focus of therapy divided into categories of primary impairments, secondary impairments, activity, environment, self-care and recreational participation, child's adaptive behaviors and health and well-being, family-centeredness of therapy, number of community programs, coordination of care and parents' perceptions that their needs were being met. Summary scores by section vary based on the construct measured.


Secondary Outcome Measures:
  • Gross Motor Function Classification System (GMFCS) [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    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.

  • Manual Ability Classification System (MACS) [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    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: up to 24-months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Physical Activity Measurement: StepWatch [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    For participants who are ambulatory, walking activity performance will be 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 will wear the StepWatch on their ankle (inside a knit cuff) each day for a seven-day sample. Specific variables will be the average daily step counts and percent time walking in low, moderate, and high stride rates based on pediatric values for the seven-day sample.

  • Physical Activity Measurement: Actigraph [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    Participants will wear a 3-dimensional accelerometer (Actigraph wGT3X) on their dominant wrist for a seven-day sample. Specific variables measured will be physical activity in raw activity counts and amount of time spent in moderate/vigorous physical activity.

  • 1 minute to 6 minute push test (1MPT, 6MPT) [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    The 1MPT to 6MPT are submaximal, clinical exercise tests, in which the total distance propelled in a manual wheelchair in meters in 1-minute and 6-minutes, under controlled conditions, are measured. Within this study for children who use a manual wheelchair for mobility, the 1MPT/6MPT will be conducted indoors or outdoors on a large, flat, hard terrain. A surveyor's measure wheel will be used to calculate the total distance wheeled and a stopwatch to keep track of the allocated time. Standardized directions are used to encourage the child to wheel as far as possible.

  • 1 stroke push test (1SPT) [ Time Frame: up to 24-months ] [ Designated as safety issue: No ]
    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 use a manual wheelchair for mobility will be tested on this measure. A surveyor's measure wheel will be used to calculate the total distance 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 ] [ Designated as safety issue: No ]
    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 is given for each setting. The higher the percentage the more support the environment provides for the child's participation within the setting.


Estimated Enrollment: 600
Study Start Date: July 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Months to 11 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with cerebral palsy of gross motor delay, ages 18 month to 11 years, and their parents.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02391948

Locations
United States, Georgia
Mercer University
Atlanta, Georgia, United States, 30341
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73117
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19102
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6G 1H1
Sponsors and Collaborators
University of Washington
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Sarah Westcott McCoy, PhD, PT University of Washington
  More Information

Additional Information:
Responsible Party: Sarah Westcott McCoy, Professor, Rehabilitation Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT02391948     History of Changes
Other Study ID Numbers: 43611-B 
Study First Received: November 23, 2014
Last Updated: December 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Cerebral palsy
Gross motor delay

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 23, 2016