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 design	Randomised controlled blinded parallel group trial
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
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

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"	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 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.