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| ID | Type | Description | Link |
|---|---|---|---|
| HKCTR-819 | Registry Identifier | Hong Kong Clinical Trials Registry |
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| Name | Class |
|---|---|
| Scoliosis Research Society | OTHER |
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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).
The study has been completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brace - Randomized | Experimental | Participants were randomized to be braced |
|
| Observation - Randomized | No Intervention | Participants were randomized to be observed only | |
| Brace - preference based | Experimental | Participants chose to be braced |
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| Observation - preference-based | No Intervention | Participants chose to be observed only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brace | Device | Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken. | Baseline and every four months |
| Measure | Description | Time Frame |
|---|---|---|
| SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II. | Baseline and every four months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel YT Fong, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Duchess of Kent Children's Hospital | Hong Kong | China |
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| ID | Term |
|---|---|
| D001915 | Braces |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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