CLINICAL TRIAL

Enriched Play Environment with Partial Body Weight Support Harness for Syndrome

Recruiting · < 18 · All Sexes · Seattle, WA

Use of Partial Body Weight Support Play Environment to Encourage Mobility and Exploration in Infants With Down Syndrome

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About the trial for Syndrome

Eligible Conditions
Syndrome · Down Syndrome (DS) · Down Syndrome · Trisomy · Body Weight

Treatment Groups

This trial involves 2 different treatments. Enriched Play Environment With Partial Body Weight Support Harness is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Enriched Play Environment with Partial Body Weight Support Harness
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Enriched Play Environment without Partial Body Weight Support Harness
OTHER

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A medical diagnosis of DS (any form)
Under 36 months old
You are able to sit independently. show original
One parent must be able to read proficiently enough in English to complete a written assessment. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through study completion, an average of 9 weeks.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through study completion, an average of 9 weeks..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Enriched Play Environment with Partial Body Weight Support Harness will improve 6 primary outcomes in patients with Syndrome. Measurement will happen over the course of Through study completion, an average of 9 weeks..

Change in gross motor performance using the Gross Motor Function Measure (GMFM-88) scores
THROUGH STUDY COMPLETION, AN AVERAGE OF 9 WEEKS.
The Gross Motor Function Measure-88 (GMFM) is a standardized, validated outcome measure in children with Down Syndrome used to assess progress in gross motor development domains of lying and rolling (score range 0-51), sitting (score range 0-60), crawling and kneeling (score range 0-42), standing (score range 0-39) and walking, running, and jumping (score range 0-72). Higher scores indicate better outcomes.
Change in Caregiver Perception of their Child's Mastery motivation using the Revised Dimensions of Mastery Questionnaire (DMQ-18) infant version
THROUGH STUDY COMPLETION, AN AVERAGE OF 9 WEEKS.
The Revised DMQ-18 has one general competence scale and six mastery motivation scales including: cognitive/object persistence, gross motor persistence, social persistence with adults, social persistence with children/peers, mastery pleasure, and negative reactions to challenge in mastery situations. It is completed by caregivers and has a score range of 41-205, with higher scores indicating greater mastery motivation.
Behavioral Observation Coding Metric 1
THROUGH STUDY COMPLETION, AN AVERAGE OF 9 WEEKS.
Frequency of exploratory behaviors will be documented via behavioral video coding from session video recordings.
Change in Movement Counts
THROUGH STUDY COMPLETION, AN AVERAGE OF 9 WEEKS.
Wrist and ankle mounted accelerometers (Actigraph GT3X+). The sensors will be placed on the child's right side wrist and ankle and covered with wrist bands. The sensors will be set to capture data in 1-second epochs during all play sessions.
Behavioral Observation Coding Metric 3
THROUGH STUDY COMPLETION, AN AVERAGE OF 9 WEEKS.
Body position of exploratory behaviors will be documented via behavioral video coding from session video recordings.
Behavioral Observation Coding Metric 2
THROUGH STUDY COMPLETION, AN AVERAGE OF 9 WEEKS.
Duration of exploratory behaviors will be documented via behavioral video coding from session video recordings.

Who is running the study

Principal Investigator
H. F.
Prof. Heather Feldner, Assistant Professor, School of Medicine Rehabilitation Medicine
University of Washington

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for down syndrome (ds)?

Down syndrome (ds) is the most common mental retardation syndrome in the world. It is more prevalent in males. The causes of the syndrome are multiple. The most common treatment is mental retardation therapy. Down syndrome (ds) is cured by early intervention.

Anonymous Patient Answer

How many people get down syndrome (ds) a year in the United States?

The actual rate of DS is much lower than the national rate, as reported by the US National Down Syndrome Congress: The true annual number of DS babies born in the US is estimated at about 200,000, less than 5% of all infants with Down syndrome in the UK and 8.5% of all DS children being born in the U.S..\n

Anonymous Patient Answer

Can down syndrome (ds) be cured?

Current treatment is effective in many respects but a significant proportion of patients experience significant relapse within two years. The outcome of treatment appears to be influenced by the type of medication used. The most effective treatment is a combination of medication to control symptoms and behaviour therapy. However, the effectiveness of medication alone is very limited and treatment in which behaviour, medication and psychotherapy all work together to achieve remission is the most favourable in terms of relapse rates.

Anonymous Patient Answer

What is down syndrome (ds)?

Down syndrome (ds) is a genetically complex disorder characterised by chromosomal rearrangements, which are often duplicated in mosaicing. The majority of cases are trisomy 21 and DYT6 is responsible for half of the DS population. Children and adults with phenotypically DS are at increased risk of developing mental disorders, which represent a major health care burden worldwide. The current understanding of the mechanisms that lead to the phenotype in DS as well as the treatment of psychiatric disorders for this population is in its infancy.

Anonymous Patient Answer

What are the signs of down syndrome (ds)?

Signs of ds include increased hair growth (gooseflesh), overgrowth of the ear-folds, large head, broad forehead (macrostomia), broad nose, broad chin, a flat nasal bridge, large, wrinkly eyes, deep-set eyes, short neck, narrow head width, small ear-folds, short upper arm and long legs and feet. The facial features of ds may have no relation to IQ and may signify a special type of intellectual disability. The physical manifestations of ds are not very specific; they are sometimes overlooked. Some of the features of ds may be due to its effects on the normal growth pattern of the brain.

Anonymous Patient Answer

What causes down syndrome (ds)?

It seems probable that genes, environmental factors, and a complex mix of factors, all influence the health of individuals with DS and their progeny. Because of the genetic variability of DS, many genetic syndromes and conditions have already been identified, yet few are universally prevalent in every individual with DS. DS may even be a sporadic (nonfamilial) condition of variable penetrance. To make appropriate decisions about prenatal treatment, genetic counseling, and the care of affected infants and children, we need to continue to evaluate and refine our understanding of the complex genetic factors that are probably responsible for the complex health issues of individuals with DS.

Anonymous Patient Answer

What are the latest developments in enriched play environment with partial body weight support harness for therapeutic use?

In a controlled study of preschoolers with Down syndrome with and without a specific intervention, in-room use of a harness system was not effective as a treatment for balance and physical function.

Anonymous Patient Answer

Have there been any new discoveries for treating down syndrome (ds)?

Only a few of new drugs for ds could be identified. Overall, there is a lack of effective new treatments for ds. There is a challenge in ds research in order to find a new drug for ds that has the best chance to succeed. There are many potential new drugs for repairing, repairing, or targeting enzymes. However, there are several possible side effects. It would benefit ds research in order to select the most effective drugs and to minimize side effects, using the best of current research.

Anonymous Patient Answer

What does enriched play environment with partial body weight support harness usually treat?

We conclude that these devices and programs can beneficially alter motor skills in children with DS. It can provide an increase in body weight, endurance, and postural stability and mobility tasks. There might be a benefit in maintaining social interaction levels and communication skills as well.

Anonymous Patient Answer

Is enriched play environment with partial body weight support harness safe for people?

Data from a recent study provides preliminary evidence that partial BWSTT harness is safe for use in non-impaired older adults. Data from a recent study warrant further research designed to inform the provision of this treatment to older adults.

Anonymous Patient Answer

How serious can down syndrome (ds) be?

Allowing patients with Down's syndrome to participate in a clinical trial provides a valuable method to obtain further and accurate information on some aspects of their condition. It also offers patients and parents with more options than the current information presented in the medical records. Such information may prove helpful in deciding to join a clinical trial, when choosing an individual physician, or when discussing future health plans. The ultimate goal is to create a clinical trial that is representative of the general population, and that incorporates most or all the issues affecting each individual patient.

Anonymous Patient Answer

What is enriched play environment with partial body weight support harness?

The type of enrichment used is an important factor in the ability to overcome the negative effects of the partial weight support harness. Thus, the type of play equipment and the design of the harness system are a major determinant in the ability to overcome the negative effects on motor skills with a partial weight support harness in children with Down's syndrome. The data should serve as preliminary information for a design that includes a variety of enrichment equipment for the different children's motor abilities.

Anonymous Patient Answer
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