Patients undergoing total knee replacement surgery Surgery
Conditions
Interventions
Kneehab® group: 6 weeks before and 6 weeks after total knee replacement surgery (30 minutes of NMES twice per day for 12 weeks), plus standard physiotherapy.
Control group: 12 weeks (6 weeks pre and p
Sponsors
The Royal Liverpool & Broadgreen University Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who are scheduled for Total Knee Replacement surgery 2. Individuals who are at least 18 years of age 3. Individuals with a body mass index (BMI) <35 4. Individuals who are walking independently with or without assistive devices 5. Must be able and willing to complete all study assessments and to be followed for the full course of the study 6. Must be able to read, write and follow instructions in English 7. Must be able and willing to provide informed consent 8. Must be willing and able to attend the additional pre-op assessment
Exclusion criteria
Exclusion criteria: 1. Individuals who have failed the pre-Total Knee Arthroplasty (TKA) operative assessment 2. Individuals with a history of foot and/or ankle pathology 3. Individuals with a history of tibial or femoral fractures 4. Individuals with a history of any underlying neurological conditions 5. Individuals with physical conditions which would make them unable to perform study procedures 6. Individuals with a total hip replacement 7. Individuals undergoing revision TKA of the same operated leg 8. Pregnant women or inadequate precautions to prevent pregnancy 9. Diagnosis of a medical condition that would contraindicate treatment with the product, e.g. skin lesions at electrode site 10. Individuals with an active implanted medical device (i.e. pacemaker, pump) 11. Individuals with a history of stroke 12. Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson?s disease, multiple sclerosis, etc.) 13. Individuals with a diagnosis of inflammatory arthritis (rheumatoid arthritis, gout or psoriatic arthritis) 14. Individuals with muscle diseases (i.e. muscular dystrophy) 15. Visible skin injury or disease on their legs 16. Principal investigator for this study, or member of study staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the efficacy of Kneehab® in promoting early recovery of quadriceps performance in patients recovering from total knee arthoplasty as determined by: 1. Clinically significant increase in isometric extensor strength compared to controls 2. Clinically significant reduction in Timed Up-and-Go (TUG) and Stair Climbing Test (SCT) score compared to controls | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life measures 2. Health economic outcomes | — |
Countries
United Kingdom
Outcome results
None listed