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Training Balance Among People With Neurodevelopmental Disabilities (TAPAS)

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ClinicalTrials.gov Identifier: NCT04293120
Recruitment Status : Terminated (COVID restrictions prevented recruitmetn)
First Posted : March 3, 2020
Last Update Posted : June 1, 2021
Sponsor:
Collaborator:
Universita di Verona
Information provided by (Responsible Party):
Mary Gannotti, University of Hartford

Tracking Information
First Submitted Date  ICMJE February 10, 2020
First Posted Date  ICMJE March 3, 2020
Last Update Posted Date June 1, 2021
Actual Study Start Date  ICMJE February 10, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
Muscle activation timing [ 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. ]
Evaluation in change in muscle activation timing of anterior tibialis, soleus, gastroc, rectus femoris, biceps femoris, rectus abdominis using electromyography
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
Muscle amplitude response [ 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. ]
Evaluation in change in amplitude of anterior tibialis, soleus, gastroc, rectus femoris, biceps femoris, rectus abdominis using electromyography
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Training Balance Among People With Neurodevelopmental Disabilities
Official Title  ICMJE Training Anticipatory Postural Adjustments Among People With Neurodevelopmental Disabilities
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Case control, matched on gender, age, and BMI
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Posture
  • Balance
  • Cerebral Palsy
  • Autism
  • Down Syndrome
Intervention  ICMJE Other: Training with weighted ball
Participants will stop or catch a weighted ball
Study Arms  ICMJE Experimental: Training
Training 4 sessions over a one week time period of 180 catches/stops with a medicine ball.
Intervention: Other: Training with weighted ball
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 26, 2021)
3
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2020)
20
Actual Study Completion Date  ICMJE August 31, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Participants

  1. Able to stand without assistance
  2. Diagnosis of cerebral palsy, Down Syndrome, or Autism Spectrum Disorder
  3. Able to stop weighted ball without falling
  4. Able to follow directions

Controls

  1. Able to stand without assistance
  2. No neurodeveloopmental disability
  3. Able to stop weighted ball without falling
  4. Able to follow directions

Exclusion Criteria:

  1. Pregnancy
  2. Unable to maintain standing when stopping a ball on a rope
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04293120
Other Study ID Numbers  ICMJE PRO19020012
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mary Gannotti, University of Hartford
Study Sponsor  ICMJE University of Hartford
Collaborators  ICMJE Universita di Verona
Investigators  ICMJE
Principal Investigator: Mary E Gannotti, PT, PhD University of Hartford
PRS Account University of Hartford
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP