Kneehab® pre and post total knee replacement surgery
ISRCTN | ISRCTN89785408 |
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DOI | https://doi.org/10.1186/ISRCTN89785408 |
Secondary identifying numbers | BMR-09-1007 |
- Submission date
- 23/03/2010
- Registration date
- 25/03/2010
- Last edited
- 13/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alasdair Santini
Scientific
Scientific
The Royal Liverpool & Broadgreen University Hospital
Thomas Drive
Liverpool
L14 3LB
United Kingdom
Phone | +44 (0)151 330 2071 |
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alasdair.santini@rlbuht.nhs.uk |
Study information
Study design | Randomised controlled blinded parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
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 |
Study acronym | Kneehab |
Study objectives | 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. |
Ethics approval(s) | The Ethics Committee of the Royal Liverpool & Broadgreen University Hospital NHS Trust, 30/06/2009 |
Health condition(s) or problem(s) studied | Patients undergoing total knee replacement surgery |
Intervention | 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. |
Intervention type | Procedure/Surgery |
Primary outcome measure | 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 measures | 1. Quality of life measures 2. Health economic outcomes |
Overall study start date | 12/04/2010 |
Completion date | 01/03/2014 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 200 |
Key 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 |
Key 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, Parkinsons 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 |
Date of first enrolment | 12/04/2010 |
Date of final enrolment | 01/03/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Royal Liverpool & Broadgreen University Hospital
Liverpool
L14 3LB
United Kingdom
L14 3LB
United Kingdom
Sponsor information
The Royal Liverpool & Broadgreen University Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Alasdair Santini
Thomas Drive
Liverpool
L14 3LB
England
United Kingdom
Phone | +44 (0)151 330 2071 |
---|---|
alasdair.santini@rlbuht.nhs.uk | |
https://ror.org/009sa0g06 |
Funders
Funder type
Hospital/treatment centre
Royal Liverpool & Broadgreen University Hospital (UK)
No information available
Bio-Medical Research, Ltd., (Ireland) - provide Kneehab (NMES) devices
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
13/04/2017: No publications found in PubMed, verifying study status with principal investigator
22/07/2014: The anticipated end date was changed from 01/07/2011 to 01/03/2014.