Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Alasdair Santini


Contact details

The Royal Liverpool & Broadgreen University Hospital
Thomas Drive
L14 3LB
United Kingdom
+44 (0)151 330 2071

Additional identifiers

EudraCT number number

Protocol/serial number


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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.


Patients undergoing total knee replacement surgery


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



Not Applicable

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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, 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information


The Royal Liverpool & Broadgreen University Hospital (UK)

Sponsor details

c/o Alasdair Santini
Thomas Drive
L14 3LB
United Kingdom
+44 (0)151 330 2071

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Royal Liverpool & Broadgreen University Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Bio-Medical Research, Ltd., (Ireland) - provide Kneehab (NMES) devices

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

Publication citations

Additional files

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.