Training Balance Among People With Neurodevelopmental Disabilities (TAPAS)

Training Anticipatory Postural Adjustments Among People With Neurodevelopmental Disabilities

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.

Study Overview

• Status: Terminated
• Conditions: Cerebral Palsy; Down Syndrome; Autism; Balance; Posture
• Intervention / Treatment: Other: Training with weighted ball

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: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Hartford, Connecticut, United States, 06117
      • University of Hartford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle activation timing	Evaluation in change in muscle activation timing of anterior tibialis, soleus, gastroc, rectus femoris, biceps femoris, rectus abdominis using electromyography	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 Measures

Outcome Measure	Measure Description	Time Frame
Muscle amplitude response	Evaluation in change in amplitude of anterior tibialis, soleus, gastroc, rectus femoris, biceps femoris, rectus abdominis using electromyography	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.

Collaborators and Investigators

• Sponsor: University of Hartford
• Collaborators: Universita di Verona
• Investigators: Principal Investigator: Mary E Gannotti, PT, PhD, University of Hartford

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Brain Damage, Chronic; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Cerebral Palsy; Down Syndrome
• Other Study ID Numbers: PRO19020012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No