Children With Neurodevelopmental DisordersNCT05443763
Exploring the Experiences and Outcomes of a Summer Intensive Therapy Program- Mixed Methods Study
A study testing An interdisciplinary intensive therapy program in people with Children With Neurodevelopmental Disorders, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of an interdisciplinary intensive therapy program for ambulatory and non-ambulatory children with neurodevelopmental disorders across the ICF and to explore caregiver experiences and perspectives of the program. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Children With Neurodevelopmental Disorders
- What is being tested?
- An interdisciplinary intensive therapy program
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2022to 1 Sep 2022
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children receiving therapy through Children's Therapy Center's Tiger Intensive Program and their caregivers from May 23, 2022, to Aug 19, 2022.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Therapy Center--MU Healthcare
Columbia, Missouri, 65201
About this study
The purpose of this study is to assess the effectiveness of an interdisciplinary intensive therapy program for ambulatory and non-ambulatory children with neurodevelopmental disorders across the ICF and to explore caregiver experiences and perspectives of the program.
Read the detailed description
The purpose of this study is to assess the effectiveness of an interdisciplinary intensive therapy program for ambulatory and non-ambulatory children with neurodevelopmental disorders across the ICF and to explore caregiver experiences and perspectives of the program. Research questions include: 1.) What are the effects of an intensive program on postural control and functional mobility for children with neurodevelopmental disorders? 2.) What are the effects of an intensive therapy program on dual tasking for children with neurodevelopmental disorders? 3.) What are the perceptions of caregivers of a multidisciplinary intensive therapy program for their children with neurodevelopmental disorders? Data will be gathered before and after the intensive program as part of usual care and ambulatory children will be further assessed in the motion analysis lab. Caregivers will complete a questionnaire about satisfaction with services and also a 4 question open-ended question survey about their experience with intensive therapy.
- Being tested
- An interdisciplinary intensive therapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An interdisciplinary intensive therapy programOther
Children will receive physical, occupation, and/or speech therapy 1-3 hours/day each for 4-5 days/week x 4 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrumented Gait Analysis
3D gait analysis in gait lab
Measured: before intensive therapy episode of care, approximately 4 weeks
Instrumented Gait Analysis
3D gait analysis in gait lab
Measured: after intensive therapy episode of care, approximately 4 weeks
Center of pressure measure
COP measure during balance task
Measured: after intensive therapy episode of care, approximately 4 weeks
Center of pressure measure
COP measure during balance task
Measured: before intensive therapy episode of care, approximately 4 weeks
Measures of processes of care (MOPC)
Questionnaire to assess satisfaction with therapy services
Measured: after intensive therapy episode of care, an average of 4 weeks
Timed up and go
TUG assessment--timed assessment including standing from a chair, walking a distance and returning to the chair
Measured: before intensive therapy episode of care, an average of 4 weeks
Timed up and go
TUG assessment--timed assessment including standing from a chair, walking a distance and returning to the chair
Measured: fter intensive therapy episode of care, an average of 4 weeks
Modified Clinical Test of Sensory Integration and Balance
mCISIB--balance test in 4 conditions
Measured: after intensive therapy episode of care, an average of 4 weeks
Modified Clinical Test of Sensory Integration and Balance
mCISIB--balance test in 4 conditions
Measured: before intensive therapy episode of care, an average of 4 weeks
Pediatric Balance Scale
PBS-balance test
Measured: before intensive therapy episode of care, an average of 4 weeks
Pediatric Balance Scale
PBS-balance test
Measured: after intensive therapy episode of care, an average of 4 weeks
Functional Gait Assessment (FGA)
Assesses functional gait performance
Measured: before intensive therapy episode of care, an average of 4 weeks
Functional Gait Assessment (FGA)
Assesses functional gait performance
Measured: after intensive therapy episode of care, an average of 4 weeks
Segmental Assessment of Trunk Control (SATCo)
Assessment of trunk control
Measured: before intensive therapy episode of care, an average of 4 weeks
Segmental Assessment of Trunk Control (SATCo)
Assessment of trunk control
Measured: after intensive therapy episode of care, an average of 4 weeks
Survey
4 open-ended questions about caregiver/child experience with intensive therapy program
Measured: after intensive therapy episode of care, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start23 May 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort study of children receiving intensive therapy and their caregivers
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Hall, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443763
- Sponsor's protocol ID
- 2090791
- Status last verified
- Jun 2022
- First submitted
- 18 May 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Experiences and Outcomes of a Summer Intensive Therapy Program- Mixed Methods Study
- ClinicalTrials.gov ID
- NCT05443763
- Acronym / sponsor ID
- 2090791
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 5 Jul 2022 (actual)
- 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 study is to assess the effectiveness of an interdisciplinary intensive therapy program for ambulatory and non-ambulatory children with neurodevelopmental disorders across the ICF and to explore caregiver experiences and perspectives of the program.
Detailed description
The purpose of this study is to assess the effectiveness of an interdisciplinary intensive therapy program for ambulatory and non-ambulatory children with neurodevelopmental disorders across the ICF and to explore caregiver experiences and perspectives of the program. Research questions include: 1.) What are the effects of an intensive program on postural control and functional mobility for children with neurodevelopmental disorders? 2.) What are the effects of an intensive therapy program on dual tasking for children with neurodevelopmental disorders? 3.) What are the perceptions of caregivers of a multidisciplinary intensive therapy program for their children with neurodevelopmental disorders? Data will be gathered before and after the intensive program as part of usual care and ambulatory children will be further assessed in the motion analysis lab. Caregivers will complete a questionnaire about satisfaction with services and also a 4 question open-ended question survey about their experience with intensive therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Cohort study of children receiving intensive therapy and their caregivers
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children receiving therapy through Children's Therapy Center's Tiger Intensive Program and their caregivers from May 23, 2022, to Aug 19, 2022.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| An interdisciplinary intensive therapy programChildren will receive physical, occupation, and/or speech therapy 1-3 hours/day each for 4-5 days/week x 4 weeks. | Other | – |
Primary outcome
Instrumented Gait Analysis
Time frame: before intensive therapy episode of care, approximately 4 weeks
3D gait analysis in gait lab
Instrumented Gait Analysis
Time frame: after intensive therapy episode of care, approximately 4 weeks
3D gait analysis in gait lab
Center of pressure measure
Time frame: after intensive therapy episode of care, approximately 4 weeks
COP measure during balance task
Center of pressure measure
Time frame: before intensive therapy episode of care, approximately 4 weeks
COP measure during balance task
Measures of processes of care (MOPC)
Time frame: after intensive therapy episode of care, an average of 4 weeks
Questionnaire to assess satisfaction with therapy services
Timed up and go
Time frame: before intensive therapy episode of care, an average of 4 weeks
TUG assessment--timed assessment including standing from a chair, walking a distance and returning to the chair
Timed up and go
Time frame: fter intensive therapy episode of care, an average of 4 weeks
TUG assessment--timed assessment including standing from a chair, walking a distance and returning to the chair
Modified Clinical Test of Sensory Integration and Balance
Time frame: after intensive therapy episode of care, an average of 4 weeks
mCISIB--balance test in 4 conditions
Modified Clinical Test of Sensory Integration and Balance
Time frame: before intensive therapy episode of care, an average of 4 weeks
mCISIB--balance test in 4 conditions
Pediatric Balance Scale
Time frame: before intensive therapy episode of care, an average of 4 weeks
PBS-balance test
Pediatric Balance Scale
Time frame: after intensive therapy episode of care, an average of 4 weeks
PBS-balance test
Functional Gait Assessment (FGA)
Time frame: before intensive therapy episode of care, an average of 4 weeks
Assesses functional gait performance
Functional Gait Assessment (FGA)
Time frame: after intensive therapy episode of care, an average of 4 weeks
Assesses functional gait performance
Segmental Assessment of Trunk Control (SATCo)
Time frame: before intensive therapy episode of care, an average of 4 weeks
Assessment of trunk control
Segmental Assessment of Trunk Control (SATCo)
Time frame: after intensive therapy episode of care, an average of 4 weeks
Assessment of trunk control
Survey
Time frame: after intensive therapy episode of care, an average of 4 weeks
4 open-ended questions about caregiver/child experience with intensive therapy program
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 24 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An interdisciplinary intensive therapy program in people with Children With Neurodevelopmental Disorders, run by University of Missouri-Columbia 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 24 Mar 2023. 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?
Instrumented Gait Analysis (time frame: before intensive therapy episode of care, approximately 4 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2023.