Physical DisabilityPLAY-LONGNCT03256318
PLAY LONG: The Effect of Sports and Recreation Participation for Young chiLdren With physicAl disabilitY
An observational study of Physical Disability and Quality of Life, run by Allina Health System at 1 site in United States.
Trial summary
Ten year longitudinal survey following children with disabilities who have participated in Sports and Recreation from a young age (5 to 10), and the parents of children who have participated in Sports and Recreation at a young age (5 to 10). Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Physical Disability, Quality of Life, Social Interaction
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to 21 Jan 2020
- Phase
- Observational
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants for this research study will be recruited from five- to ten- year old children and their parents who are participating in adapted sports and recreation programs. These children will have a variety of physical disabilities, and be participating in a wide range of sports and recreation programs, including basketball, skiing, baseball, archery, bowling, curling, cycling, golf, horseback riding, martial arts, Nordic skiing, soccer, rock climbing, scuba, swimming, water skiing, rugby, softball tennis, and track and field. The types of sport and recreation activities changes from year to year, as activities become more or less popular.
Who may be able to join
- At the time of enrollment, the child must be between the ages of 5 and 10 and be participating in an adapted sports and recreation program.
- At the time of enrollment, the parent must have a child between the ages of 5 and 10, who is participating in an adapted sports and recreation program.
- Children and parents who are enrolled in the study will continue to participate in the study for 10 years.
Who cannot join
- Children who are younger than 5 or older than 10 will not be entered into the study, nor will parents whose children are younger than 5 or older than 10 be entered into the study. .
- Individuals who do not read and write in English will be excluded from the study.
- Children who are wards of the state, or in foster care will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Courage Kenny Rehabilitation Institute
Golden Valley, Minnesota, 55422
About this study
Official title: PLAY LONG: The Effect of Sports and Recreation Participation for Young chiLdren With physicAl disabilitY - Longitudinal Study
Ten year longitudinal survey following children with disabilities who have participated in Sports and Recreation from a young age (5 to 10), and the parents of children who have participated in Sports and Recreation at a young age (5 to 10). These children will be followed for 10 years with surveys every 6 months, whether they are currently participating in sports and recreation activities or not.
The purpose of this longitudinal study is to examine the effects of early participation in organized sports and recreation activities (S\&R) on self-reported health and health-related quality of life of children and youth (C\&Y) with disabilities and their parent-reported social participation. This project will examine child and parent reported differences between:
- C\&Y with disabilities who participate in S\&R and those who have discontinued participation in S\&R programs
- C\&Y with disabilities who participate in sports vs. those who participate in recreation, and
- C\&Y with disabilities who participate in S\&R and normative data on C\&Y with disabilities and those without disabilities.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention; surveys/questionnaires only
| Study group | Role | What they receive |
|---|---|---|
| Children in Sports and Rec | Children with disabilities who enter the study between ages 5 and 10 who are participating in a Sports and Recreation Program. They will receive no intervention, only surveys. Receives: Other: No intervention | |
| Comparison Children | Children with disabilities who enter the study between ages 5 and 10 and end participation in Sports and Recreation Program at a later date. They will receive no intervention, only surveys. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health related quality of life
As measured by KIDSCREEN-10 questionnaire
Measured: Every 6 months for 10 years.
Secondary outcomes (2)
Change in general health
Self reported general health as measured by PROMIS Pediatric Global Health Measure
Measured: Every 6 months for 10 years.
Change in social participation
Self reported (or parent-reported) social participation as measured by PROMIS Pediatric Global Health Measure
Measured: Every 6 months for 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start30 Aug 2017
- Primary completion21 Jan 2020
- Study completion21 Jan 2020
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Flinn, Allina Health System
- Investigators
- Nancy Flinn, PhD, OTR/L, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256318
- Sponsor's protocol ID
- CKNF-1701
- Acronym
- PLAY-LONG
- Status last verified
- Feb 2020
- First submitted
- 18 Aug 2017
- Last updated
- 6 Feb 2020
- 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 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLAY LONG: The Effect of Sports and Recreation Participation for Young chiLdren With physicAl disabilitY - Longitudinal Study
- ClinicalTrials.gov ID
- NCT03256318
- Acronym / sponsor ID
- PLAY-LONG / CKNF-1701
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 22 Aug 2017 (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.
Ten year longitudinal survey following children with disabilities who have participated in Sports and Recreation from a young age (5 to 10), and the parents of children who have participated in Sports and Recreation at a young age (5 to 10). These children will be followed for 10 years with surveys every 6 months, whether they are currently participating in sports and recreation activities or not.
The purpose of this longitudinal study is to examine the effects of early participation in organized sports and recreation activities (S\&R) on self-reported health and health-related quality of life of children and youth (C\&Y) with disabilities and their parent-reported social participation. This project will examine child and parent reported differences between:
- C\&Y with disabilities who participate in S\&R and those who have discontinued participation in S\&R programs
- C\&Y with disabilities who participate in sports vs. those who participate in recreation, and
- C\&Y with disabilities who participate in S\&R and normative data on C\&Y with disabilities and those without disabilities.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children in Sports and Rec | – | Other: No interventionChildren with disabilities who enter the study between ages 5 and 10 who are participating in a Sports and Recreation Program. They will receive no intervention, only surveys. |
| Comparison Children | – | Other: No interventionChildren with disabilities who enter the study between ages 5 and 10 and end participation in Sports and Recreation Program at a later date. They will receive no intervention, only surveys. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants for this research study will be recruited from five- to ten- year old children and their parents who are participating in adapted sports and recreation programs. These children will have a variety of physical disabilities, and be participating in a wide range of sports and recreation programs, including basketball, skiing, baseball, archery, bowling, curling, cycling, golf, horseback riding, martial arts, Nordic skiing, soccer, rock climbing, scuba, swimming, water skiing, rugby, softball tennis, and track and field. The types of sport and recreation activities changes from year to year, as activities become more or less popular.
Key inclusion criteria (3 listed)
- At the time of enrollment, the child must be between the ages of 5 and 10 and be participating in an adapted sports and recreation program.
- At the time of enrollment, the parent must have a child between the ages of 5 and 10, who is participating in an adapted sports and recreation program.
- Children and parents who are enrolled in the study will continue to participate in the study for 10 years.
Key exclusion criteria (3 listed)
- Children who are younger than 5 or older than 10 will not be entered into the study, nor will parents whose children are younger than 5 or older than 10 be entered into the study. .
- Individuals who do not read and write in English will be excluded from the study.
- Children who are wards of the state, or in foster care will be excluded from the study.
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 |
|---|---|---|
| No interventionNo intervention; surveys/questionnaires only | Other | Children in Sports and Rec, Comparison Children |
Primary outcome
Change in health related quality of life
Time frame: Every 6 months for 10 years.
As measured by KIDSCREEN-10 questionnaire
2 secondary outcomes
Change in general health
Time frame: Every 6 months for 10 years.
Change in social participation
Time frame: Every 6 months for 10 years.
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- 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.
Nancy Flinn, PhD, OTR/L principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Disability and Quality of Life, run by Allina Health System 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 3 inclusion and 3 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 6 Feb 2020. 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: Insufficient recruitment). 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?
Change in health related quality of life (time frame: Every 6 months for 10 years.). 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 6 Feb 2020.