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| [ ...Back to search results ] | [ Print-friendly version ] |
| Kneehab® pre and post total knee replacement surgery |
| ISRCTN | ISRCTN89785408 |
| ClinicalTrials.gov identifier | |
| Public title | Kneehab® pre and post total knee replacement surgery |
| Scientific title | The effect of augmenting a standard therapy protocol with a 12-week peri-operative programme of Kneehab® neuromuscular electrical stimulation in patients undergoing total knee replacement: A randomised controlled trial |
| Acronym | Kneehab |
| Serial number at source | BMR-09-1007 |
| Study hypothesis | Neuromuscular electrical stimulation (NMES) can help prepare the quadriceps muscle for the rehabilitation phase by building exercise capacity before the operation. The immediate deficit, which normally follows knee surgery, would therefore be compensated to some extent and the post-operative NMES treatment would be expected to counteract the activation inhibition that is thought to occur in the early weeks following surgery. Overall, the patient would be in a better position to benefit from conventional rehabilitation exercises aimed at improved co-ordination and functional performance. |
| Lay summary | |
| Ethics approval | The Ethics Committee of the Royal Liverpool & Broadgreen University Hospital NHS Trust, approved the protocol on the 30th of June 30 2009 |
| Study design | Randomised controlled blinded parallel group trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Patients undergoing total knee replacement surgery. |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 12/04/2010 |
| Anticipated end date | 01/07/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet. |
| Target number of participants | 200 |
| 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 post) standard physiotherapy. |
| Primary outcome measure(s) |
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 outcome measure(s) |
1. Quality of life measures
2. Health economic outcomes |
| Sources of funding |
1. Royal Liverpool & Broadgreen University Hospital (UK)
2. Bio-Medical Research, Ltd., (Ireland) - provide Kneehab (NMES) devices |
| Trial website | |
| Publications | |
| Contact name | Dr Alasdair Santini |
| Address |
The Royal Liverpool & Broadgreen University Hospital
Thomas Drive |
| City/town | Liverpool |
| Zip/Postcode | L14 3LB |
| Country | United Kingdom |
| Tel | +44 (0)151 330 2071 |
| alasdair.santini@rlbuht.nhs.uk | |
| Sponsor | The Royal Liverpool & Broadgreen University Hospital (UK) |
| Address |
c/o Alasdair Santini
Thomas Drive |
| City/town | Liverpool |
| Zip/Postcode | L14 3LB |
| Country | United Kingdom |
| Tel | +44 (0)151 330 2071 |
| alasdair.santini@rlbuht.nhs.uk | |
| Date applied | 23/03/2010 |
| Last edited | 25/03/2010 |
| Date ISRCTN assigned | 25/03/2010 |
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