CompletedNot Applicable

Validation of a Knee Brace for Gonarthrosis

Canada5 participantsStarted 2023-03-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Has worn an ODRA knee brace multiple hours a day during the last 6 months Exclusion Criteria: * Wounds on the lower body

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ease of Use Measurement Scale

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.

Physical Symptoms

Timeframe: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm

Trial details

NCT IDNCT05814471

SponsorTOPMED

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-27

Results submitted2025-04-11

View on ClinicalTrials.gov More Gonarthrosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Has worn an ODRA knee brace multiple hours a day during the last 6 months Exclusion Criteria: * Wounds on the lower body

What they're measuring

Ease of Use Measurement Scale

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.

Physical Symptoms

Timeframe: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm