A Multiple Baseline Design Study to Investigate the Effectiveness of OT-SI Using an Intensive Intervention Model

Study Overview
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Brief Summary
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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).

Official Title
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A Multiple Baseline Design Study to Investigate the Effectiveness of OT-SI Using an Intensive Intervention Model

Conditions
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Motor Coordination or Function; Developmental Disorder

Intervention / Treatment
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* Other: OT-SI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 59 Months
Maximum Age: 107 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OT-SI<br>Occupational therapy using a sensory integration approach | Other: OT-SI<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in motor coordination: Jumping Jacks | Amount of correct jumps in specified time frame (10 seconds) | Baseline to 10 weeks | 
| Change in motor coordination: Finger to Nose Touching | Amount of correct touches in specified time frame (10 seconds) | Baseline to 10 weeks | 
| Change in motor coordination: Single Leg Stance Balance | Time held in seconds | Baseline to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline to 10 weeks |