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| Name | Class |
|---|---|
| Natural Sciences and Engineering Research Council, Canada | OTHER |
| Laboratoire Victhom | UNKNOWN |
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A study about the effects of different fastening systems for knee braces on comfort, ease of installation and treatment efficacy both physical and psychological. Two different systems will be tested, velcro straps and a cable-fastening system.
There are 2 main types of knee braces for gonarthrosis: soft knee braces and rigid knee braces. Soft knee braces use malleable materials such as cloth or rubber to apply forces on the leg whereas rigid braces use plastic or metal shells. Three main types of fastening systems are used on these types of orthoses: velcro systems, hybrid systems and cable fastening systems. Therefore, different configurations exist to reduce biomechanical deficits caused by the pathology.
Each fastening system has its advantages and disadvantages. Velcro straps are fast and intuitive to use, altough multiple difficulties are mentionned: adjusment, cleaning, the number of straps needed to maintain the knee brace in position as well as the noise while detaching the straps. Hybrid systems regularly use velcro straps to which are added quick-release fasteners to simplify the installation and uninstallation process. Cable fastening systems also use quick-release fasteners. The adjusment process is simple and precise with minimal noise with these systems.
Comfort, efficacy and ease of use are essential qualities of a knee brace. Confort is primordial as it is directly linked to treatment adherence by the patients. Efficacy of a knee brace treatment may be measured by symptom or medication use evolution but also with daily practice of problematic movement by the patient. Ease of use must be optimized as it presents an opportunity to increase treatment adherence. The goal of the fastening system developped in partnership with Laboratoires Victhom is to increase ease of use of the knee brace while maintaining comfort and treatment efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjustement period(velcro)first, then Cable fastening system then Velcro Straps | Experimental | A new knee brace is worn for a 14 days adjustement period with velcro straps. Then the brace is worn with a cable fastening system for a first 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. The second 14 days intervention period is done with velcro straps keeping the brace in position. |
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| Adjustement period(velcro)first, then Velcro Straps then Cable fastening system | Active Comparator | A new knee brace is worn for a 14 days adjustement period with velcro straps. The first 14 days intervention period is done with velcro straps keeping the brace in position. Then the brace is worn with a cable fastening system for a second 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cable fastening system and 3d printed straps(14 days) | Device | The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Use Measurement Scale | The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use) | Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace. |
| Ease of Use Measurement Scale | The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use) | Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace. |
| Comfort Measurement Scale | The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort). | Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace. |
| Comfort Measurement Scale | The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort). | Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace. |
| Physical Symptoms | Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms); |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TOPMED | Québec | Quebec | G1S1C1 | Canada |
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Total enrollment was 5 participants, since participants did all interventions in a sequence, the total amount of participants for each intervention was 5 since there were no exclusions nor drop-outs.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adjustement Period(Velcro)First, Then Cable Fastening System Then Velcro Straps | A new knee brace is worn for a 14 days adjustement period with velcro straps. Then the brace is worn with a cable fastening system for a first 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. The second 14 days intervention period is done with velcro straps keeping the brace in position. |
| FG001 | Adjustement Period(Velcro)First, Then Velcro Straps Then Cable Fastening System | A new knee brace is worn for a 14 days adjustement period with velcro straps. The first 14 days intervention period is done with velcro straps keeping the brace in position. Then the brace is worn with a cable fastening system for a second 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adjustment Period(14 Days) |
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| First Intervention(14 Days) |
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| Second Intervention(14 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who completed the intervention protocol. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ease of Use Measurement Scale | The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use) | Posted | Mean | Standard Deviation | score on a scale | Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace. |
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6 weeks (2 weeks adjustment period + 2 weeks of treatment for each arm)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cable Fastening System | The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a cable fastening system and 3d printed straps. Cable fastening system and 3d printed straps: The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edith Martin | Topmed | 418 683-2104 | 1302 | emartin@topmed.ca |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2025 | Jun 25, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 25, 2025 | Jun 25, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Randomized trial with condition crossover
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| Velcro straps system(14 days) | Device | The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks. |
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| Adjustment period(Velcro-14 days) | Device | The participants will wear a new Odra knee brace held in place with by a velcro straps system for 2 weeks. |
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| Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period. |
| Physical Symptoms | Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms); | Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm |
| Psychological Symptoms | Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms); | Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period. |
| Psychological Symptoms | Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms); | Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Psychological Symptoms | Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Total scores ranges from 0 (no symptoms) to 100 (high levels of anxiety, depression hostility and concentration symptoms). | Mean | Standard Deviation | units on a scale |
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| Physical Symptoms | Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Total scores ranges from 0 (extreme knee problems) to 100 (no symptoms). | Mean | Standard Deviation | units on a scale |
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The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system. Velcro straps system: The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks. |
| OG002 | Adjustment Period(Velcro-14 Days) | The participants wore a new Odra knee brace held in place with by a velcro straps system for 2 weeks. |
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| Primary | Ease of Use Measurement Scale | The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use) | Posted | Mean | Standard Deviation | score on a scale | Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace. |
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| Primary | Comfort Measurement Scale | The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort). | Posted | Mean | Standard Deviation | score on a scale | Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace. |
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| Primary | Comfort Measurement Scale | The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort). | Posted | Mean | Standard Deviation | score on a scale | Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace. |
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| Primary | Physical Symptoms | Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms); | Posted | Mean | Standard Deviation | score on a scale | Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period. |
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| Primary | Physical Symptoms | Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms); | Posted | Mean | Standard Deviation | score on a scale | Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm |
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| Primary | Psychological Symptoms | Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms); | Posted | Mean | Standard Deviation | score on a scale | Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period. |
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| Primary | Psychological Symptoms | Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms); | Posted | Mean | Standard Deviation | score on a scale | Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Velcro Straps | The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system. Velcro straps system: The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Adjustment Period | The participants will wear a new Odra knee brace held in place with by a velcro straps system for 2 weeks. | 0 | 5 | 0 | 5 | 0 | 5 |
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is 1 year from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.