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

Motor Coordination or Function; Developmental Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355417
• Other study ID #: HM20012008
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: March 20, 2019

Study information

• Verified date: March 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 20, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 59 Months to 107 Months

Eligibility

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)

Related Conditions & MeSH terms

• Developmental Disabilities
• Motor Coordination or Function; Developmental Disorder

Intervention

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).

Locations

Country	Name	City	State
United States	Children's Hospital of Richmond at VCU	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in motor coordination: Jumping Jacks	Amount of correct jumps in specified time frame (10 seconds)	Baseline to 10 weeks
Primary	Change in motor coordination: Finger to Nose Touching	Amount of correct touches in specified time frame (10 seconds)	Baseline to 10 weeks
Primary	Change in motor coordination: Single Leg Stance Balance	Time held in seconds	Baseline to 10 weeks
Secondary	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
Secondary	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
Secondary	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