Motor Coordination or Function; Developmental DisorderCAN-DoNCT02673658
Project for Cognitive Advancement in Infants With Neuromotor Disorders
A study testing Motor + problem solving and body weight support training in people with Motor Coordination or Function; Developmental Disorder, run by Duquesne University at 1 site in United States.
Trial summary
The purpose of this longitudinal study is to examine the ongoing interaction between the domains of cognitive and motor development in infants with neuromotor disability, and to compare outcomes of two groups of infants receiving two different types of home-based, parent-delivered physical therapy intervention, in… Read more about this study
- Who is it for?
- Ages 7 to 36 months
- Conditions the study is for
- Motor Coordination or Function; Developmental Disorder
- What is being tested?
- Motor + problem solving and body weight support training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 14 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with a diagnosis of a neuromotor disorder such as cerebral palsy, or a birth history and developmental history indicative of cerebral palsy (prematurity, intraventricular hemorrhage, periventricular leukomalacia) will be selected for this study. The infants will be at Gross Motor Function Classification Scale (GMFCS) levels I, II, or III, because infants at levels IV and V would be unlikely to reach the level of sitting independence to enter the study. Additional behavioral inclusion criteria are: between the ages of 9 months and 3 years at the time of entry into the study; the child should already be independent in prop sitting (sitting with arm support) for at least 1 minute, and be able to lift one arm up in sitting (after being placed in sitting) to reach for a toy placed directly in front of them without losing balance
Who cannot join
- blindness, dislocated hip, pending orthopedic or neurologic surgery which would interrupt the time period of the intervention, additional diagnosis that affects the neuromuscular system such as spina bifida. A child would not qualify for the study if sitting skills were mature. Mature sitting is operationally defined as: the ability to sit independently without using the arms for support for five minutes or more without falling; reaching for toys using both hands at once without disrupting balance; moving in and out of the sitting position independently.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project for Cognitive Advancement in Infants With Neuromotor DisOrders:The CAN-DO Project
The purpose of this longitudinal study is to examine the ongoing interaction between the domains of cognitive and motor development in infants with neuromotor disability, and to compare outcomes of two groups of infants receiving two different types of home-based, parent-delivered physical therapy intervention, in order to determine which intervention is more effective in advancing cognitive as well as motor development. Knowledge of the effectiveness of two types of intervention will lead to improved early intervention for children with developmental disabilities, as well as future studies to examine ongoing outcomes.
Read the detailed description
This longitudinal study will examine the ongoing interaction between the domains of cognitive and motor development in infants with neuromotor disability, as well as compare differences between groups of infants receiving two types of intervention.
The specific aims for this study are:
- To measure the changes of the head, trunk and pelvis as the primary orienting segments of the body during the achievement of sitting and the transition to crawling in infants with neuromotor disability.
- Describe the changes in problem-solving and cognitive abilities of infants with neuromotor disability as they transition to stable sitting and then to crawling.
- Using eye-tracking technology, quantify the evolution of focused attention in infants with neuromotor disability as the motor skills of sitting and the transition to crawling emerge.
- Compare motor skill, visual attention and cognitive change as sitting and crawling emerge between groups of infants with neuromotor disabilities receiving two different interventions, and determine the effects of distinctly different paradigms: one that focuses simply on building motor skill, and the other that builds motor and cognition together.
This is a longitudinal study, with between group comparisons to determine the effectiveness of the intervention, and within group comparisons to determine change over time. Measures will occur in the home at baseline, at the end of month 1 of intervention, the end of month 2, the end of month 3, and at a 9 month follow-up visit, for a total of 5 measurement times. Each session will take approximately 1 hour each time. Because we want to look at the child's movement and posture, the child should be clothed in either an undergarment or a bathing suit that allows a view of their trunk, legs and arms during the 5 measurement sessions. We will video the child's movement and posture and play doing two standardized infant tests during these measurement sessions. The child will sit on the floor as independently as they can and reach for toys and move through as many developmental postures as they can (crawling, pulling to stand, moving in and out of sitting). The parent will always be next to their child during measurement sessions.
Children will participate in one of the parent-delivered interventions for 3-months after being randomized to one of two groups. Both intervention groups are parent-delivered interventions, with differing goals and differing training. Parents will be trained in one of the following approaches:
Motor-based problem solving approach or the body weight support (BWS) approach.
In both of the above approaches, parents will receive weekly, one-hour sessions at home for updates and training from a physical therapist to advance the program for individual infants. Thus, there will be a total of 12 sessions with a therapist. Each program is individualized because no two infants will have exactly the same skill set. This individualization of programs is standard practice for early intervention. Generally, the suggestions will follow standard developmental guidelines, with sequencing of skills presented in the order of normal development. Both of these approaches are currently used in early intervention for young children with developmental disabilities, but we do not know which is more effective, or if either approach is effective.
- Being tested
- Motor + problem solving, body weight support training
- Keywords
- infant development, early intervention
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor + problem solvingBehavioural
Developmental motor tasks incorporating cognitive concepts such as object permanence
body weight support trainingBehavioural
Mobility tasks to change positions or move the body with assistance to initiate movement
| Study group | Role | What they receive |
|---|---|---|
| Motor + problem solving | Active comparator | This method focuses on spontaneous movement (rather than facilitated movement). Self-initiated, functionally directed movement is emphasized. Intervention includes guidance and cues, which gently call the child's attention to the support surface, and a set-up of the environment for small increments of movement so that the child can solve a movement problem. Passive movements are not used. Each small increment of movement to advance sitting skill or other motor skills is paired with a specific object or toy that challenges a cognitive concept for spatial problem solving. In this approach, the parent will adjust toys and supports to encourage changes of position from sitting, to transitions in and out of sitting to crawling or standing, but will not assist the child physically. Receives: Behavioral: Motor + problem solving |
| Body weight support training | Active comparator | In this approach, infants will be supported physically by their parents to take steps, sit, crawl, or reach, in practice sessions focused simply on the motor skill. Toys or problem solving will not be part of this intervention, but the child will be assisted (lifted by the parent) through movement to improve strength and learn specific movements and new positions. The child will be able to perform as much of the movement as possible, but the parents will initiate the activity if the child does not initiate, and the parent will lift the child passively through the task if the child is unable to move. Receives: Behavioral: body weight support training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure
Longitudinal Gross Motor Function Measure change measures from baseline to: 1 month, 2 months, 3 months and 9 months post baseline
Measured: baseline, 1 month, 2 month, 3 months, up to 9 months post baseline
Secondary outcomes (2)
Visual attention - time to switch between 2 targets, and look time
Longitudinal eye tracking change measures from baseline to: 1 month, 2 months, 3 months and 9 months post baseline
Measured: baseline, 1 month, 2 month, 3 months, up to 9 months post baseline
Early Problem Solving Indicator
Longitudinal Early Problem Solving Indicator change measures from baseline to:,
1 month, 2 months, 3 months and 9 months post baseline
Measured: baseline, 1 month, 2 month, 3 months, up to 9 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startOct 2015
- Primary completion15 Dec 2018
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor Coordination or Function; Developmental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Sponsor
- Investigators
- Regina T Harbourne, PhD, Principal investigator, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673658
- Sponsor's protocol ID
- 4100068712 Project 1
- Acronym
- CAN-Do
- Status last verified
- Feb 2019
- First submitted
- 29 Jan 2016
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: No plan to make individual participant data available
Publications
Harbourne RT, Berger SE. Embodied Cognition in Practice: Exploring Effects of a Motor-Based Problem-Solving Intervention. Phys Ther. 2019 Jun 1;99(6):786-796. doi: 10.1093/ptj/pzz031.
PubMed 30810750
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project for Cognitive Advancement in Infants With Neuromotor DisOrders:The CAN-DO Project
- ClinicalTrials.gov ID
- NCT02673658
- Acronym / sponsor ID
- CAN-Do / 4100068712 Project 1
- Keywords
- infant development, early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- Oct 2015
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this longitudinal study is to examine the ongoing interaction between the domains of cognitive and motor development in infants with neuromotor disability, and to compare outcomes of two groups of infants receiving two different types of home-based, parent-delivered physical therapy intervention, in order to determine which intervention is more effective in advancing cognitive as well as motor development. Knowledge of the effectiveness of two types of intervention will lead to improved early intervention for children with developmental disabilities, as well as future studies to examine ongoing outcomes.
Detailed description
This longitudinal study will examine the ongoing interaction between the domains of cognitive and motor development in infants with neuromotor disability, as well as compare differences between groups of infants receiving two types of intervention.
The specific aims for this study are:
- To measure the changes of the head, trunk and pelvis as the primary orienting segments of the body during the achievement of sitting and the transition to crawling in infants with neuromotor disability.
- Describe the changes in problem-solving and cognitive abilities of infants with neuromotor disability as they transition to stable sitting and then to crawling.
- Using eye-tracking technology, quantify the evolution of focused attention in infants with neuromotor disability as the motor skills of sitting and the transition to crawling emerge.
- Compare motor skill, visual attention and cognitive change as sitting and crawling emerge between groups of infants with neuromotor disabilities receiving two different interventions, and determine the effects of distinctly different paradigms: one that focuses simply on building motor skill, and the other that builds motor and cognition together.
This is a longitudinal study, with between group comparisons to determine the effectiveness of the intervention, and within group comparisons to determine change over time. Measures will occur in the home at baseline, at the end of month 1 of intervention, the end of month 2, the end of month 3, and at a 9 month follow-up visit, for a total of 5 measurement times. Each session will take approximately 1 hour each time. Because we want to look at the child's movement and posture, the child should be clothed in either an undergarment or a bathing suit that allows a view of their trunk, legs and arms during the 5 measurement sessions. We will video the child's movement and posture and play doing two standardized infant tests during these measurement sessions. The child will sit on the floor as independently as they can and reach for toys and move through as many developmental postures as they can (crawling, pulling to stand, moving in and out of sitting). The parent will always be next to their child during measurement sessions.
Children will participate in one of the parent-delivered interventions for 3-months after being randomized to one of two groups. Both intervention groups are parent-delivered interventions, with differing goals and differing training. Parents will be trained in one of the following approaches:
Motor-based problem solving approach or the body weight support (BWS) approach.
In both of the above approaches, parents will receive weekly, one-hour sessions at home for updates and training from a physical therapist to advance the program for individual infants. Thus, there will be a total of 12 sessions with a therapist. Each program is individualized because no two infants will have exactly the same skill set. This individualization of programs is standard practice for early intervention. Generally, the suggestions will follow standard developmental guidelines, with sequencing of skills presented in the order of normal development. Both of these approaches are currently used in early intervention for young children with developmental disabilities, but we do not know which is more effective, or if either approach is effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor + problem solving | Active comparator | Behavioral: Motor + problem solvingThis method focuses on spontaneous movement (rather than facilitated movement). Self-initiated, functionally directed movement is emphasized. Intervention includes guidance and cues, which gently call the child's attention to the support surface, and a set-up of the environment for small increments of movement so that the child can solve a movement problem. Passive movements are not used. Each small increment of movement to advance sitting skill or other motor skills is paired with a specific object or toy that challenges a cognitive concept for spatial problem solving. In this approach, the parent will adjust toys and supports to encourage changes of position from sitting, to transitions in and out of sitting to crawling or standing, but will not assist the child physically. |
| Body weight support training | Active comparator | Behavioral: body weight support trainingIn this approach, infants will be supported physically by their parents to take steps, sit, crawl, or reach, in practice sessions focused simply on the motor skill. Toys or problem solving will not be part of this intervention, but the child will be assisted (lifted by the parent) through movement to improve strength and learn specific movements and new positions. The child will be able to perform as much of the movement as possible, but the parents will initiate the activity if the child does not initiate, and the parent will lift the child passively through the task if the child is unable to move. |
Who may qualify
- Ages
- 7 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with a diagnosis of a neuromotor disorder such as cerebral palsy, or a birth history and developmental history indicative of cerebral palsy (prematurity, intraventricular hemorrhage, periventricular leukomalacia) will be selected for this study. The infants will be at Gross Motor Function Classification Scale (GMFCS) levels I, II, or III, because infants at levels IV and V would be unlikely to reach the level of sitting independence to enter the study. Additional behavioral inclusion criteria are: between the ages of 9 months and 3 years at the time of entry into the study; the child should already be independent in prop sitting (sitting with arm support) for at least 1 minute, and be able to lift one arm up in sitting (after being placed in sitting) to reach for a toy placed directly in front of them without losing balance
Key exclusion criteria (1 listed)
- blindness, dislocated hip, pending orthopedic or neurologic surgery which would interrupt the time period of the intervention, additional diagnosis that affects the neuromuscular system such as spina bifida. A child would not qualify for the study if sitting skills were mature. Mature sitting is operationally defined as: the ability to sit independently without using the arms for support for five minutes or more without falling; reaching for toys using both hands at once without disrupting balance; moving in and out of the sitting position independently.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor + problem solvingDevelopmental motor tasks incorporating cognitive concepts such as object permanence | Behavioural | Motor + problem solving |
| body weight support trainingMobility tasks to change positions or move the body with assistance to initiate movement | Behavioural | Body weight support training |
Primary outcome
Gross Motor Function Measure
Time frame: baseline, 1 month, 2 month, 3 months, up to 9 months post baseline
Longitudinal Gross Motor Function Measure change measures from baseline to: 1 month, 2 months, 3 months and 9 months post baseline
2 secondary outcomes
Visual attention - time to switch between 2 targets, and look time
Time frame: baseline, 1 month, 2 month, 3 months, up to 9 months post baseline
Early Problem Solving Indicator
Time frame: baseline, 1 month, 2 month, 3 months, up to 9 months post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Derived from this study: PubMed 30810750Harbourne RT, Berger SE. Embodied Cognition in Practice: Exploring Effects of a Motor-Based Problem-Solving Intervention. Phys Ther. 2019 Jun 1;99(6):786-796. doi: 10.1093/ptj/pzz031.
- Individual participant dataSharing planned: Undecided. No plan to make individual participant data available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina T Harbourne, PhD principal investigator
Duquesne University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor + problem solving and body weight support training in people with Motor Coordination or Function; Developmental Disorder, run by Duquesne University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure (time frame: baseline, 1 month, 2 month, 3 months, up to 9 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02673658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.