Back to resultsA Multiple Baseline Design Study to Investigate the Effectiveness of OT-SI Using an Intensive Intervention Model
Primary Purpose
Motor Coordination or Function; Developmental Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OT-SI
Sponsored by
About this trial
This is an interventional treatment trial for Motor Coordination or Function; Developmental Disorder
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)
Sites / Locations
- Children's Hospital of Richmond at VCU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OT-SI
Arm Description
Occupational therapy using a sensory integration approach
Outcomes
Primary Outcome Measures
Change in motor coordination: Jumping Jacks
Amount of correct jumps in specified time frame (10 seconds)
Change in motor coordination: Finger to Nose Touching
Amount of correct touches in specified time frame (10 seconds)
Change in motor coordination: Single Leg Stance Balance
Time held in seconds
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03355417
First Posted
November 20, 2017
Last Updated
March 29, 2019
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03355417
Brief Title
A Multiple Baseline Design Study to Investigate the Effectiveness of OT-SI Using an Intensive Intervention Model
Official Title
A Multiple Baseline Design Study to Investigate the Effectiveness of OT-SI Using an Intensive Intervention Model
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
March 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Coordination or Function; Developmental Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study will use a non-concurrent multiple baseline design (MBD) where subjects will serve as their own control
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OT-SI
Arm Type
Experimental
Arm Description
Occupational therapy using a sensory integration approach
Intervention Type
Other
Intervention Name(s)
OT-SI
Intervention Description
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 Outcome Measure Information:
Title
Change in motor coordination: Jumping Jacks
Description
Amount of correct jumps in specified time frame (10 seconds)
Time Frame
Baseline to 10 weeks
Title
Change in motor coordination: Finger to Nose Touching
Description
Amount of correct touches in specified time frame (10 seconds)
Time Frame
Baseline to 10 weeks
Title
Change in motor coordination: Single Leg Stance Balance
Description
Time held in seconds
Time Frame
Baseline to 10 weeks
Secondary Outcome Measure Information:
Title
Change in Sensory Processing Measure-Home Form
Description
A standardized set of questionnaires used for rating a child's sensory processing issues, motor planning (praxis), and social participation.
Time Frame
Baseline to 10 weeks
Title
Change in Bruinincks-Oseretsky Test of Motor Proficiency (BOT-2) Short-Form
Description
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.
Time Frame
Baseline to 10 weeks
Title
Change in Goal Attainment Scaling
Description
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.
Time Frame
Baseline to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
59 Months
Maximum Age & Unit of Time
107 Months
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey Reynolds, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Richmond at VCU
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Multiple Baseline Design Study to Investigate the Effectiveness of OT-SI Using an Intensive Intervention Model
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