Kneehab® pre and post total knee replacement surgery

ISRCTN ISRCTN89785408
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

The Royal Liverpool & Broadgreen University Hospital
Thomas Drive
Liverpool
L14 3LB
United Kingdom

Phone +44 (0)151 330 2071
Email alasdair.santini@rlbuht.nhs.uk

Study information

Study designRandomised controlled blinded parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleThe 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 acronymKneehab
Study objectivesNeuromuscular 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) studiedPatients undergoing total knee replacement surgery
InterventionKneehab® 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 typeProcedure/Surgery
Primary outcome measureDetermine 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 measures1. Quality of life measures
2. Health economic outcomes
Overall study start date12/04/2010
Completion date01/03/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants200
Key inclusion criteria1. 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 criteria1. 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
Date of first enrolment12/04/2010
Date of final enrolment01/03/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Royal Liverpool & Broadgreen University Hospital
Liverpool
L14 3LB
United Kingdom

Sponsor information

The Royal Liverpool & Broadgreen University Hospital (UK)
Hospital/treatment centre

c/o Alasdair Santini
Thomas Drive
Liverpool
L14 3LB
England
United Kingdom

Phone +44 (0)151 330 2071
Email alasdair.santini@rlbuht.nhs.uk
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.