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TerminatedNCT04293120TAPASUpdated Jun 1, 2021

Training Balance Among People With Neurodevelopmental Disabilities

An interventional study of Training with weighted ball in Posture, Balance and Cerebral Palsy, sponsored by University of Hartford. Terminated at 1 site in United States. Open to participants aged 8 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-01.

Sponsored by University of Hartford · Not applicable, Interventional, and Treatment

Why this study was terminated
COVID restrictions prevented recruitmetn
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
8 Years to 25 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Posture
  • Balance
  • Cerebral Palsy
  • Autism
  • Down Syndrome
03

In context

Cerebral Palsy

1,852 studies on the registry are indexed under Cerebral Palsy; 437 are open to participants now.

This study's enrollment of 3 is below the median of 34 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

University of Hartford is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  1. Pregnancy
  2. Unable to maintain standing when stopping a ball on a rope
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Training

    Training 4 sessions over a one week time period of 180 catches/stops with a medicine ball.

    Other: Training with weighted ball

Interventions

  • OtherTraining with weighted ball

    Participants will stop or catch a weighted ball

06

What researchers measure

Primary outcomes

  1. Muscle activation timing

    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 outcomes

  1. Muscle amplitude response

    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.

07

Study locations

1 site
  • University of Hartford
    West Hartford, Connecticut 06117, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04293120
Lead sponsor
University of Hartford
Collaborators
Universita di Verona
Responsible party
Mary Gannotti (Professor, University of Hartford) — Principal investigator
First posted
Mar 3, 2020
Start date
Feb 10, 2020
Primary completion
Aug 31, 2020
Completion
Aug 31, 2020
Last update
Jun 1, 2021

Study contacts

Mary E Gannotti, PT, PhD
principal investigator · University of Hartford

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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