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Completed

NCT Number: NCT03355417

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).

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Key information

Conditions

Motor Coordination or Function; Developmental Disorder Developmental Disabilities Mental Disorders Neurodevelopmental Disorders

Age range

59 month–107 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23220, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Primary outcomes

  1. Change in motor coordination: Jumping Jacks

    Time frame: Baseline to 10 weeks

    Amount of correct jumps in specified time frame (10 seconds)

  2. Change in motor coordination: Finger to Nose Touching

    Time frame: Baseline to 10 weeks

    Amount of correct touches in specified time frame (10 seconds)

  3. Change in motor coordination: Single Leg Stance Balance

    Time frame: Baseline to 10 weeks

    Time held in seconds

Secondary outcomes

  1. Change in Sensory Processing Measure-Home Form

    Time frame: Baseline to 10 weeks

    A standardized set of questionnaires used for rating a child's sensory processing issues, motor planning (praxis), and social participation.

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

    Time frame: Baseline to 10 weeks

    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.

  3. Change in Goal Attainment Scaling

    Time frame: Baseline to 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2017
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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