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

NCT ID: NCT03355417

Last Updated: 2019-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2019-03-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OT-SI

Occupational therapy using a sensory integration approach

Group Type: EXPERIMENTAL

OT-SI

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 59 Months
• Maximum Eligible Age: 107 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacey Reynolds, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Children's Hospital of Richmond at VCU

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20012008

Identifier Type: -

Identifier Source: org_study_id