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

NCT03355417 | Completed

• 1 other identifier: HM20012008
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Motor Coordination or Function; Developmental Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in Sensory Processing Measure-Home Form

  Baseline to 10 weeks

• Change in Bruinincks-Oseretsky Test of Motor Proficiency (BOT-2) Short-Form

  Baseline to 10 weeks

• Change in Goal Attainment Scaling

  Baseline to 10 weeks

Study Arms (1)

OT-SI

EXPERIMENTAL

Occupational therapy using a sensory integration approach

Other: OT-SI

Interventions

OT-SI OTHER

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).

OT-SI

Eligibility Criteria

• Age: 59 Months - 107 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23220, United States

Location

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Stacey Reynolds, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 28, 2017
• Study Start: March 12, 2018
• Primary Completion: March 20, 2019
• Study Completion: March 20, 2019
• Last Updated: April 1, 2019

Record last verified: 2019-03

Locations

US (1)