Contact information
Type
Scientific
Primary contact
Dr Alasdair Santini
ORCID ID
Contact details
The Royal Liverpool & Broadgreen University Hospital
Thomas Drive
Liverpool
L14 3LB
United Kingdom
+44 (0)151 330 2071
alasdair.santini@rlbuht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BMR-09-1007
Study information
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
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.
Ethics approval
The Ethics Committee of the Royal Liverpool & Broadgreen University Hospital NHS Trust, 30/06/2009
Study design
Randomised controlled blinded parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
12/04/2010
Overall trial end date
01/03/2014
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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
Recruitment start date
12/04/2010
Recruitment end date
01/03/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Royal Liverpool & Broadgreen University Hospital
Liverpool
L14 3LB
United Kingdom
Sponsor information
Organisation
The Royal Liverpool & Broadgreen University Hospital (UK)
Sponsor details
c/o Alasdair Santini
Thomas Drive
Liverpool
L14 3LB
United Kingdom
+44 (0)151 330 2071
alasdair.santini@rlbuht.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Liverpool & Broadgreen University Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bio-Medical Research, Ltd., (Ireland) - provide Kneehab (NMES) devices
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary