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Training Balance Among People With Neurodevelopmental Disabilities (TAPAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04293120
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Universita di Verona
Information provided by (Responsible Party):
Mary Gannotti, University of Hartford

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.

Condition or disease Intervention/treatment Phase
Posture Balance Cerebral Palsy Autism Down Syndrome Other: Training with weighted ball Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Case control, matched on gender, age, and BMI
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Training Anticipatory Postural Adjustments Among People With Neurodevelopmental Disabilities
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Training
Training 4 sessions over a one week time period of 180 catches/stops with a medicine ball.
Other: Training with weighted ball
Participants will stop or catch a weighted ball




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04293120


Contacts
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Contact: Mary E Gannotti, PT, PhD 860-768-5373 gannottimary@gmail.com
Contact: Holly Stevenson 860-768-5419 hstevenso@hartford.edu

Locations
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United States, Connecticut
University of Hartford Recruiting
West Hartford, Connecticut, United States, 06117
Contact: Mary E Gannotti, PT, PhD    860-768-5373    gannotti@hartford.edu   
Sponsors and Collaborators
University of Hartford
Universita di Verona
Investigators
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Principal Investigator: Mary E Gannotti, PT, PhD University of Hartford

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Responsible Party: Mary Gannotti, Professor, University of Hartford
ClinicalTrials.gov Identifier: NCT04293120    
Other Study ID Numbers: PRO19020012
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Palsy
Down Syndrome
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn