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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03355417
Enrollment
3
Registered
2017-11-28
Start date
2018-03-12
Completion date
2019-03-20
Last updated
2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor Coordination or Function; Developmental Disorder

Brief 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).

Interventions

OTHEROT-SI

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).

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study will use a non-concurrent multiple baseline design (MBD) where subjects will serve as their own control

Eligibility

Sex/Gender
ALL
Age
59 Months to 107 Months
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in motor coordination: Jumping JacksBaseline to 10 weeksAmount of correct jumps in specified time frame (10 seconds)
Change in motor coordination: Finger to Nose TouchingBaseline to 10 weeksAmount of correct touches in specified time frame (10 seconds)
Change in motor coordination: Single Leg Stance BalanceBaseline to 10 weeksTime held in seconds

Secondary

MeasureTime frameDescription
Change in Sensory Processing Measure-Home FormBaseline to 10 weeksA standardized set of questionnaires used for rating a child's sensory processing issues, motor planning (praxis), and social participation.
Change in Bruinincks-Oseretsky Test of Motor Proficiency (BOT-2) Short-FormBaseline to 10 weeksA 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.
Change in Goal Attainment ScalingBaseline to 10 weeksGoal 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026