Back to resultsTraining Balance Among People With Neurodevelopmental Disabilities (TAPAS)
Primary Purpose
Posture, Balance, Cerebral Palsy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training with weighted ball
Sponsored by
About this trial
This is an interventional treatment trial for Posture
Eligibility Criteria
Inclusion Criteria:
Participants
- Able to stand without assistance
- Diagnosis of cerebral palsy, Down Syndrome, or Autism Spectrum Disorder
- Able to stop weighted ball without falling
- Able to follow directions
Controls
- Able to stand without assistance
- No neurodeveloopmental disability
- Able to stop weighted ball without falling
- Able to follow directions
Exclusion Criteria:
- Pregnancy
- Unable to maintain standing when stopping a ball on a rope
Sites / Locations
- University of Hartford
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Training
Arm Description
Training 4 sessions over a one week time period of 180 catches/stops with a medicine ball.
Outcomes
Primary Outcome Measures
Muscle activation timing
Evaluation in change in muscle activation timing of anterior tibialis, soleus, gastroc, rectus femoris, biceps femoris, rectus abdominis using electromyography
Secondary Outcome Measures
Muscle amplitude response
Evaluation in change in amplitude of anterior tibialis, soleus, gastroc, rectus femoris, biceps femoris, rectus abdominis using electromyography
Full Information
NCT ID
NCT04293120
First Posted
February 10, 2020
Last Updated
May 26, 2021
Sponsor
University of Hartford
Collaborators
Universita di Verona
1. Study Identification
Unique Protocol Identification Number
NCT04293120
Brief Title
Training Balance Among People With Neurodevelopmental Disabilities
Acronym
TAPAS
Official Title
Training Anticipatory Postural Adjustments Among People With Neurodevelopmental Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID restrictions prevented recruitmetn
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hartford
Collaborators
Universita di Verona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a case control pilot study to investigate the impact of a short-term intervention on training anticipatory postural adjustments in a population of people with neurodevelopmental disabilities.
Detailed Description
Data will be collected by using a weighted pendulum to provide a posterior perturbation to test subjects' postural reactions pre and post-intervention. Intervention will include four sessions of weighted ball tosses/weighted tether ball stops to improve muscle activation patterns and efficiency. EMG sensors, 3D motion analysis, and force plates will be used to collect the necessary data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posture, Balance, Cerebral Palsy, Autism, Down Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case control, matched on gender, age, and BMI
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training
Arm Type
Experimental
Arm Description
Training 4 sessions over a one week time period of 180 catches/stops with a medicine ball.
Intervention Type
Other
Intervention Name(s)
Training with weighted ball
Intervention Description
Participants will stop or catch a weighted ball
Primary Outcome Measure Information:
Title
Muscle activation timing
Description
Evaluation in change in muscle activation timing of anterior tibialis, soleus, gastroc, rectus femoris, biceps femoris, rectus abdominis using electromyography
Time Frame
Pre-intervention muscle activation timing will be assessed on the initial visit. Post-intervention muscle activation timing will be assessed immediately after the fourth training session, at most, 7 days later.
Secondary Outcome Measure Information:
Title
Muscle amplitude response
Description
Evaluation in change in amplitude of anterior tibialis, soleus, gastroc, rectus femoris, biceps femoris, rectus abdominis using electromyography
Time Frame
Pre-intervention muscle amplitude response will be assessed on the initial visit. Post-intervention muscle amplitude response will be assessed immediately after the fourth training session, at most, 7 days later.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants
Able to stand without assistance
Diagnosis of cerebral palsy, Down Syndrome, or Autism Spectrum Disorder
Able to stop weighted ball without falling
Able to follow directions
Controls
Able to stand without assistance
No neurodeveloopmental disability
Able to stop weighted ball without falling
Able to follow directions
Exclusion Criteria:
Pregnancy
Unable to maintain standing when stopping a ball on a rope
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E Gannotti, PT, PhD
Organizational Affiliation
University of Hartford
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hartford
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Training Balance Among People With Neurodevelopmental Disabilities
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