Training Balance Among People With Neurodevelopmental Disabilities

NCT04293120 | Terminated

• 1 other identifier: PRO19020012
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Posture; Balance; Cerebral Palsy; Autism; Down Syndrome

Outcome Measures

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

  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

  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.

Study Arms (1)

Training

EXPERIMENTAL

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

Other: Training with weighted ball

Interventions

Training with weighted ball OTHER

Participants will stop or catch a weighted ball

Training

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Unable to maintain standing when stopping a ball on a rope

Sponsors & Collaborators

• University of Hartford: lead
• Universita di Verona: collaborator

Study Sites (1)

University of Hartford

West Hartford, Connecticut, 06117, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Autistic Disorder; Down Syndrome

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Mary E Gannotti, PT, PhD

  University of Hartford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Case control, matched on gender, age, and BMI

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: March 3, 2020
• Study Start: February 10, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)