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

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 Overview

• Status: Completed
• Conditions: Motor Coordination or Function; Developmental Disorder
• Intervention / Treatment: Other: OT-SI

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Children's Hospital of Richmond at VCU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OT-SI; Occupational therapy using a sensory integration approach	Other: OT-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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): March 20, 2019
• Study Completion (Actual): March 20, 2019

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• Other Study ID Numbers: HM20012008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No