Motor Coordination or Function; Developmental DisorderNCT03355417
A Multiple Baseline Design Study to Investigate the Effectiveness of OT-SI Using an Intensive Intervention Model
A study testing OT-SI in people with Motor Coordination or Function; Developmental Disorder, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The investigators hypothesize that children completing 30 sessions of occupational therapy using a sensory integration approach (OT-SI) will demonstrate positive changes in outcome measures related to motor coordination, functional performance and sensory processing (changes pre-post test). Read more about this study
- Who is it for?
- Ages 59 to 107 months
- Conditions the study is for
- Motor Coordination or Function; Developmental Disorder
- What is being tested?
- OT-SI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2018to 20 Mar 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 59 to 107 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a medical diagnosis of "lack of coordination" or "other coordination impairment"
- Children and caregivers able to communicate verbally in English
- Sensory processing impairments as determined by scores in the SPM-H form (screening). Scores must fall in the "definite dysfunction" range in one of three categories (Body Awareness, Balance \& Motion, or Planning \& Ideas), OR fall in the "some problems" range in 2/3 areas.
Who cannot join
- Diagnosed with autism spectrum disorder or other significant psychological impairment (e.g. bipolar disorder)
- Receiving occupational therapy services at CHoR or another therapy site for more than 3 months
- Significant motor impairment (e.g., cerebral palsy)
- Significant language impairment (e.g., non-verbal, or aphasia)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23220
About this study
The investigators hypothesize that children completing 30 sessions of occupational therapy using a sensory integration approach (OT-SI) will demonstrate positive changes in outcome measures related to motor coordination, functional performance and sensory processing (changes pre-post test).
- Being tested
- OT-SI
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT-SIOther
Occupational therapy using a sensory integration approach (OT-SI) 3x per week for 10 weeks. A typical session will be 1 hour (total of 3 hours per week).
| Study group | Role | What they receive |
|---|---|---|
| OT-SI | Experimental | Occupational therapy using a sensory integration approach Receives: Other: OT-SI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor coordination: Jumping Jacks
Amount of correct jumps in specified time frame (10 seconds)
Measured: Baseline to 10 weeks
Change in motor coordination: Finger to Nose Touching
Amount of correct touches in specified time frame (10 seconds)
Measured: Baseline to 10 weeks
Change in motor coordination: Single Leg Stance Balance
Time held in seconds
Measured: Baseline to 10 weeks
Secondary outcomes (3)
Change in Sensory Processing Measure-Home Form
A standardized set of questionnaires used for rating a child's sensory processing issues, motor planning (praxis), and social participation.
Measured: Baseline to 10 weeks
Change in Bruinincks-Oseretsky Test of Motor Proficiency (BOT-2) Short-Form
A standardized assessment that uses goal-directed motor activities to measure a wide array of gross and fine motor skills in individuals 4-21 years old.
Measured: Baseline to 10 weeks
Change in Goal Attainment Scaling
Goal Attainment Scaling (GAS) is a way to develop individual goals for a patient that can be measured over the course of intervention using a standardized scale. Goals are rated on a 5-point scale and criteria for each level is established prior to starting treatment. While each patient has individual goals that are meaningful to him/her and his/her family, the outcome measurement scale is standardized so that it can be used for statistical analysis with other patients' goals. The expected level of outcome is established at initial goal setting, and 0 is used to rate an outcome where a patient achieves the expected level. If patient achieves a better than expected outcome, the score can be +1 (somewhat better) or +2 (much better). If patient achieves a worse outcome than expected, the score can be -1 (somewhat worse) or -2 (much worse). GAS goals are identified during semi-structured interview with patient and/or caregivers, and 3-4 goals are set and weighted by importance.
Measured: Baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start12 Mar 2018
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study will use a non-concurrent multiple baseline design (MBD) where subjects will serve as their own control
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacey Reynolds, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355417
- Sponsor's protocol ID
- HM20012008
- Status last verified
- Mar 2019
- First submitted
- 20 Nov 2017
- Last updated
- 1 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Baseline Design Study to Investigate the Effectiveness of OT-SI Using an Intensive Intervention Model
- ClinicalTrials.gov ID
- NCT03355417
- Acronym / sponsor ID
- HM20012008
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 28 Nov 2017 (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 investigators hypothesize that children completing 30 sessions of occupational therapy using a sensory integration approach (OT-SI) will demonstrate positive changes in outcome measures related to motor coordination, functional performance and sensory processing (changes pre-post test).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will use a non-concurrent multiple baseline design (MBD) where subjects will serve as their own control
| Arm | Type | Receives |
|---|---|---|
| OT-SI | Experimental | Other: OT-SIOccupational therapy using a sensory integration approach |
Who may qualify
- Ages
- 59 to 107 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Have a medical diagnosis of "lack of coordination" or "other coordination impairment"
- Children and caregivers able to communicate verbally in English
- Sensory processing impairments as determined by scores in the SPM-H form (screening). Scores must fall in the "definite dysfunction" range in one of three categories (Body Awareness, Balance \& Motion, or Planning \& Ideas), OR fall in the "some problems" range in 2/3 areas.
Key exclusion criteria (4 listed)
- Diagnosed with autism spectrum disorder or other significant psychological impairment (e.g. bipolar disorder)
- Receiving occupational therapy services at CHoR or another therapy site for more than 3 months
- Significant motor impairment (e.g., cerebral palsy)
- Significant language impairment (e.g., non-verbal, or aphasia)
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 |
|---|---|---|
| OT-SIOccupational therapy using a sensory integration approach (OT-SI) 3x per week for 10 weeks. A typical session will be 1 hour (total of 3 hours per week). | Other | OT-SI |
Primary outcome
Change in motor coordination: Jumping Jacks
Time frame: Baseline to 10 weeks
Amount of correct jumps in specified time frame (10 seconds)
Change in motor coordination: Finger to Nose Touching
Time frame: Baseline to 10 weeks
Amount of correct touches in specified time frame (10 seconds)
Change in motor coordination: Single Leg Stance Balance
Time frame: Baseline to 10 weeks
Time held in seconds
3 secondary outcomes
Change in Sensory Processing Measure-Home Form
Time frame: Baseline to 10 weeks
Change in Bruinincks-Oseretsky Test of Motor Proficiency (BOT-2) Short-Form
Time frame: Baseline to 10 weeks
Change in Goal Attainment Scaling
Time frame: Baseline to 10 weeks
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 1 Apr 2019.
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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.
Stacey Reynolds, PhD principal investigator
Virginia Commonwealth 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 OT-SI in people with Motor Coordination or Function; Developmental Disorder, run by Virginia Commonwealth 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 3 inclusion and 4 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 1 Apr 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?
Change in motor coordination: Jumping Jacks (time frame: Baseline to 10 weeks). The study lists 3 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 1 Apr 2019.