Adolescent Idiopathic ScoliosisNCT00989495
Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study
A study testing Brace in people with Adolescent Idiopathic Scoliosis, run by The University of Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to gain initial experience and information for proper planning and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study of bracing). Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Nov 2011
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of AIS
- Age ≥10 years
- Risser sign 0-2
- Cobb's angle 20 deg to <25 deg with documented deterioration of at least 5 deg within the past 4 months (with a maximum of 10 days deviation), or 25 deg to <30 deg
Who cannot join
- History of treatment of AIS
- >= 1 year postmenarchal (for girls only)
- Physical or mental disability to adhere to bracing
- Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature
- Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace)
- Difficulty to read, understand, and complete the study questionnaires
- Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-blind Comprehensive Cohort Study Incorporating a Randomized Controlled Design on Bracing in AIS: A Feasibility Study
The purpose of this study is to gain initial experience and information for proper planning and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study of bracing).
Read the detailed description
The study has been completed.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Brace
- Keywords
- AIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BraceDevice
Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
| Study group | Role | What they receive |
|---|---|---|
| Brace - Randomized | Experimental | Participants were randomized to be braced Receives: Device: Brace |
| Observation - Randomized | No intervention | Participants were randomized to be observed only |
| Brace - preference based | Experimental | Participants chose to be braced Receives: Device: Brace |
| Observation - preference-based | No intervention | Participants chose to be observed only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken.
Measured: Baseline and every four months
Secondary outcomes (1)
SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II.
Measured: Baseline and every four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startOct 2008
- Primary completionMar 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Scoliosis Research Society
- Responsible party
- Principal investigator, Dr Daniel Yee Tak FONG, The University of Hong Kong
- Investigators
- Daniel YT Fong, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989495
- Sponsor's protocol ID
- dytfong
- Other IDs
- HKCTR-819
- Status last verified
- Dec 2014
- First submitted
- 1 Oct 2009
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blind Comprehensive Cohort Study Incorporating a Randomized Controlled Design on Bracing in AIS: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00989495
- Acronym / sponsor ID
- dytfong
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- AIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Scoliosis Research Society
- Study start
- Oct 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 5 Oct 2009 (estimated)
- 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.
The purpose of this study is to gain initial experience and information for proper planning and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study of bracing).
Detailed description
The study has been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brace - Randomized | Experimental | Device: BraceParticipants were randomized to be braced |
| Observation - Randomized | No intervention | –Participants were randomized to be observed only |
| Brace - preference based | Experimental | Device: BraceParticipants chose to be braced |
| Observation - preference-based | No intervention | –Participants chose to be observed only |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of AIS
- Age ≥10 years
- Risser sign 0-2
- Cobb's angle 20 deg to <25 deg with documented deterioration of at least 5 deg within the past 4 months (with a maximum of 10 days deviation), or 25 deg to <30 deg
Key exclusion criteria (7 listed)
- History of treatment of AIS
- >= 1 year postmenarchal (for girls only)
- Physical or mental disability to adhere to bracing
- Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature
- Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace)
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 |
|---|---|---|
| BraceWearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day | Device | Brace - Randomized, Brace - preference based |
Primary outcome
Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken.
Time frame: Baseline and every four months
1 secondary outcome
SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II.
Time frame: Baseline and every four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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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.
Daniel YT Fong, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brace in people with Adolescent Idiopathic Scoliosis, run by The University of Hong Kong at 1 site in China.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 3 Dec 2014. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken. (time frame: Baseline and every four months). 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 3 Dec 2014.