Cerebral Palsy Clinical Trial
Official title:
Developmental Trajectories of Impairments, Health, and Participation of Children With Cerebral Palsy
NCT number | NCT02391948 |
Other study ID # | 43611 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2013 |
Est. completion date | March 31, 2017 |
Verified date | January 2019 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 724 |
Est. completion date | March 31, 2017 |
Est. primary completion date | August 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Months to 12 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Western Ontario | London | Ontario |
United States | Mercer University | Atlanta | Georgia |
United States | University of Oklahoma | Oklahoma City | Oklahoma |
United States | Drexel University | Philadelphia | Pennsylvania |
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Patient-Centered Outcomes Research Institute |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides) | 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. | up to 24-months | |
Other | Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day | 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. | up to 24-months | |
Other | Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity | 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. | up to 24-months | |
Other | Physical Activity Measurement: Actigraph: Average Physical Activity | 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. | up to 24-months | |
Other | 1 Minute to 6 Minute Push Test (1MPT, 6MPT) | 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. | up to 24-months | |
Other | 1 Stroke Push Test (1SPT) | 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. | up to 24-months | |
Other | Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY) | 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. | up to 24-months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Percentage of All Participants According to Gross Motor Function Classification System (GMFCS) | 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. | Baseline | |
Secondary | Manual Ability Classification System (MACS) | 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. | Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline) | |
Secondary | Communication Function Classification System (CFCS) | 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. | Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05317234 -
Genetic Predisposition in Cerebral Palsy
|
N/A | |
Recruiting |
NCT05576948 -
Natural History of Cerebral Palsy Prospective Study
|
||
Completed |
NCT04119063 -
Evaluating Wearable Robotic Assistance on Gait
|
Early Phase 1 | |
Completed |
NCT03264339 -
The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy
|
N/A | |
Completed |
NCT05551364 -
Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy
|
N/A | |
Completed |
NCT03902886 -
Independent Walking Onset of Children With Cerebral Palsy
|
||
Recruiting |
NCT05571033 -
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
|
N/A | |
Not yet recruiting |
NCT04081675 -
Compliance in Children With Cerebral Palsy Supplied With AFOs
|
||
Completed |
NCT02167022 -
Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy
|
N/A | |
Completed |
NCT04012125 -
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy
|
N/A | |
Enrolling by invitation |
NCT05619211 -
Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities
|
Phase 1 | |
Completed |
NCT04489498 -
Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
|
||
Completed |
NCT03677193 -
Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy
|
N/A | |
Recruiting |
NCT06450158 -
Robot-assisted Training in Children With CP
|
N/A | |
Completed |
NCT04093180 -
Intensive Neurorehabilitation for Cerebral Palsy
|
N/A | |
Completed |
NCT02909127 -
The Pediatric Eating Assessment Tool
|
||
Not yet recruiting |
NCT06377982 -
Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy
|
Phase 1 | |
Not yet recruiting |
NCT06007885 -
Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.
|
N/A | |
Not yet recruiting |
NCT03183427 -
Corpus Callosum Size in Patients With Pineal Cyst
|
N/A | |
Active, not recruiting |
NCT03078621 -
Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy
|
Phase 1/Phase 2 |