PostureTAPASNCT04293120
Training Balance Among People With Neurodevelopmental Disabilities
A study testing Training with weighted ball in people with Posture and Balance, run by University of Hartford at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 8 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Posture, Balance, Cerebral Palsy
- What is being tested?
- Training with weighted ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 10Show fewer
- Able to stand without assistance
- No neurodeveloopmental disability
- Able to stop weighted ball without falling
- Able to follow directions
Who cannot join
- Pregnancy
- Unable to maintain standing when stopping a ball on a rope
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hartford
West Hartford, Connecticut, 06117
About this study
Official title: 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.
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.
- Conditions
- Posture, Balance, Cerebral Palsy, Autism, Down Syndrome
- Being tested
- Training with weighted ball
- Medical subject headings
- Cerebral Palsy, Autistic Disorder, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with weighted ballOther
Participants will stop or catch a weighted ball
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Training 4 sessions over a one week time period of 180 catches/stops with a medicine ball. Receives: Other: Training with weighted ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activation timing
Evaluation in change in muscle activation timing of anterior tibialis, soleus, gastroc, rectus femoris, biceps femoris, rectus abdominis using electromyography
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start10 Feb 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: COVID restrictions prevented recruitmetn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case control, matched on gender, age, and BMI
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hartford
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona
- Responsible party
- Principal investigator, Mary Gannotti, University of Hartford
- Investigators
- Mary E Gannotti, PT, PhD, Principal investigator, University of Hartford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293120
- Sponsor's protocol ID
- PRO19020012
- Acronym
- TAPAS
- Status last verified
- May 2021
- First submitted
- 10 Feb 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Anticipatory Postural Adjustments Among People With Neurodevelopmental Disabilities
- ClinicalTrials.gov ID
- NCT04293120
- Acronym / sponsor ID
- TAPAS / PRO19020012
- Conditions
- Posture, Balance, Cerebral Palsy, Autism, Down Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID restrictions prevented recruitmetn
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of HartfordUniversity, hospital or other
- Collaborators
- Universita di Verona
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case control, matched on gender, age, and BMI
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: Training with weighted ballTraining 4 sessions over a one week time period of 180 catches/stops with a medicine ball. |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Unable to maintain standing when stopping a ball on a rope
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training with weighted ballParticipants will stop or catch a weighted ball | Other | Training |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study was stopped early (reason given: COVID restrictions prevented recruitmetn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E Gannotti, PT, PhD principal investigator
University of Hartford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with weighted ball in people with Posture and Balance, run by University of Hartford at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID restrictions prevented recruitmetn). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.