Gonarthrosis
Conditions
Keywords
knee brace, orthosis, treatment efficacy, arthrosis, comfort, ease of use
Brief summary
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.
Detailed description
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.
Interventions
DEVICECable fastening system and 3d printed straps(14 days)
The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
DEVICEVelcro straps system(14 days)
The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.
DEVICEAdjustment period(Velcro-14 days)
The participants will wear a new Odra knee brace held in place with by a velcro straps system for 2 weeks.
Sponsors
Natural Sciences and Engineering Research Council, Canada
Laboratoire Victhom
TOPMED
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized trial with condition crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has worn an ODRA knee brace multiple hours a day during the last 6 months
Exclusion criteria
* Wounds on the lower body
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use Measurement 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. | 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) |
| Comfort Measurement 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. | 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). |
| Physical Symptoms | Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period. | Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms); |
| Psychological Symptoms | Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period. | 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); |
Countries
Canada
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants who completed the intervention protocol. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Physical Symptoms | 68.9 units on a scale STANDARD_DEVIATION 23.9 |
| Psychological Symptoms | 28.0 units on a scale STANDARD_DEVIATION 27.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Canada | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
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).
Time frame: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cable Fastening System | Comfort Measurement Scale | 90 score on a scale | Standard Deviation 13.7 |
| Velcro Straps | Comfort Measurement Scale | 80 score on a scale | Standard Deviation 20.9 |
| Adjustment Period(Velcro-14 Days) | Comfort Measurement Scale | 62.5 score on a scale | Standard Deviation 20.9 |
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cable Fastening System | Comfort Measurement Scale | 90 score on a scale | Standard Deviation 11.2 |
| Velcro Straps | Comfort Measurement Scale | 75 score on a scale | Standard Deviation 30.6 |
| Adjustment Period(Velcro-14 Days) | Comfort Measurement Scale | 77.5 score on a scale | Standard Deviation 16 |
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)
Time frame: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cable Fastening System | Ease of Use Measurement Scale | 4.05 score on a scale | Standard Deviation 0.26 |
| Velcro Straps | Ease of Use Measurement Scale | 3.00 score on a scale | Standard Deviation 1.21 |
| Adjustment Period(Velcro-14 Days) | Ease of Use Measurement Scale | 4.05 score on a scale | Standard Deviation 0.78 |
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cable Fastening System | Ease of Use Measurement Scale | 4.60 score on a scale | Standard Deviation 0.33 |
| Velcro Straps | Ease of Use Measurement Scale | 3.45 score on a scale | Standard Deviation 1.17 |
| Adjustment Period(Velcro-14 Days) | Ease of Use Measurement Scale | 3.80 score on a scale | Standard Deviation 0.54 |
Primary
Physical Symptoms
Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms);
Time frame: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cable Fastening System | Physical Symptoms | 0.6 score on a scale | Standard Deviation 3.6 |
Primary
Physical Symptoms
Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms);
Time frame: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cable Fastening System | Physical Symptoms | 2.0 score on a scale | Standard Deviation 2.3 |
| Velcro Straps | Physical Symptoms | -0.2 score on a scale | Standard Deviation 5.4 |
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);
Time frame: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cable Fastening System | Psychological Symptoms | -3.4 score on a scale | Standard Deviation 6.5 |
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);
Time frame: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cable Fastening System | Psychological Symptoms | -7.4 score on a scale | Standard Deviation 6.1 |
| Velcro Straps | Psychological Symptoms | -6.7 score on a scale | Standard Deviation 6.1 |