Condition category
Surgery
Date applied
23/03/2010
Date assigned
25/03/2010
Last edited
22/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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.

On 22/07/2014 the anticipated end date was changed from 01/07/2011 to 01/03/2014.

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, 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

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

Publication citations

Additional files

Editorial Notes