None listed
Conditions
Brief summary
This study will explore whether wearing a knee sleeve following surgery for ruptures of the anterior cruciate ligament (of the knee) improves function (defined with a self-reported questionnaire), maximum hop distance, knee movement patterns during a hop, and thigh muscle strength . The hypothesis is that participants (following such surgery) who wear the sleeve at least one hour for six weeks will have greater improvement in function, hop distance, knee movement patterns and thigh muscle strength than a group of participants who do not wear the knee sleeve.
Interventions
This study will have two parts: (1) the immediate effects and (2) 6-week effects of wearing a knee sleeve on clinical outcomes.
For Part 1, all participants will undergo a cross-over study whereby they will be performing two sets of hops: one set not wearing a knee sleeve (control condition) and one set while wearing the knee sleeve on the injured side (Sleeve condition).
For Part 2, they will be randomised into two groups, with those allocated to the Intervention group being asked to wear a kn
This study will have two parts: (1) the immediate effects and (2) 6-week effects of wearing a knee sleeve on clinical outcomes. For Part 1, all participants will undergo a cross-over study whereby they will be performing two sets of hops: one set not wearing a knee sleeve (control condition) and one set while wearing the knee sleeve on the injured side (Sleeve condition). For Part 2, they will be randomised into two groups, with those allocated to the Intervention group being asked to wear a knee sleeve on the injured side for 6 weeks, and the Control group not being provided with such a sleeve. Two different sets of hops will be used: (1) one maximum horizontal hop for distance, 3 repetitions for each side (uninjured versus injured sides); (2) Step down hop: participants will stand on a 30 cm box, step down onto the force plate, and hop forward on that leg at a distance of 60-70% of the uninjured horizontal hop distance. Five trials will be performed for each side. Three-dimensional movement analysis of the knee will be performed for the stance phase. For Part 1, the cross-over trials, both hops (maximum horizontal hop, and step-down hop) will be performed with and without wearing a knee sleeve. Prior to each condition, the participant will be asked to rest for 10 minutes and then walk on a treadmill for 10 minutes. There will thus be an overall wash-up period of 20 minutes. The intervention consists of use of the GenuTrain® knee sleeve (Bauerfeind AG, Zeulenroda, Germany). This is a flexible elastic/knitted sleeve to provide support to the knee without limiting range of motion in any direction. The GenuTrain® is a ‘CE’ certified medical device, ensuring that the device has been manufactured considering safety, performance and benefit, and on-going monitoring of the manufacturer and the device. Manufacturer's guidelines will be used to individually size the sleeve. Participants will be asked to wear the sleeve on the injured side daily for at least 1 hour for six weeks. They will be required to complete a diary of the use of the knee sleeve, emailed to the primary investigator on a weekly basis.
Sponsors
Dr Gisela Sole
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
• Men and women (aged 18-40 inclusive) with an ACL reconstruction at least 6 months but less than 3 years (36 months) previously. • We are specifically seeking individuals who have not yet reached full functional level. The functional level will be assessed with the International Knee Documentation Committee Subjective Knee Form (IKDC): participants must have achieved between 40 and 80/100. [Higher IKDC scores indicate better function. By including those between 40 and 80/100, those with very poor function (<40) are excluded, as well as those who have regained very good function (>80).]
Exclusion criteria
• Revision ACL reconstruction of the same knee, or a previous ACL reconstruction of the opposite knee; • Pregnancy; • Any other lower limb, pelvic or low back musculoskeletal injuries or disorders that needed health care over the past 6 months or are currently limiting their daily function, sports or occupational performance; • Known systemic, neurological or cardiovascular disorders, • International Knee Disability Classification (IKDC) score: total score less than 40 or greater than 80/100 (to exclude those with significant symptoms and thus should not be hopping; and those who have nearly recovered where a sleeve would clinically be less likely to add benefit); reporting a ‘moderately’, ‘very’ or ‘extremely’ swollen knee (Question 4); reporting their ‘highest level of activity’ to be only ‘light activities’ due to pain, swelling, or giving way. • Body mass index (BMI) above 30 kg/m2 (i.e., the participants can be overweight but not obese).
Outcome results
None listed