Condition category
Musculoskeletal Diseases
Date applied
11/03/2017
Date assigned
14/03/2017
Last edited
29/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Osteoarthritis of the knee is a type of arthritis that is caused by the wear and tear of the cartilage lining the knee joint. This causes pain, stiffness and a loss in mobility (movement). The best treatment option for knee osteoarthritis is to have a total knee replacement (TKR) surgery. TKR is a common procedure where the weight bearing surfaces of the knee joint are replaced with metal and plastic components. This is done to relieve pain and disability. The main complaints of patients who are undergoing TKR due to osteoarthritis are the difficulties performing everyday tasks (such as going up a staircase or walking on uneven roads) and the increased risk of falling. Usual care after a TKR is to undergo rehabilitation that is aimed to increase the muscle and improve the motion of the knees. However, this does not address patient’s difficulties performing daily tasks. Research has shown that rehabilitation that includes specific techniques aimed at increasing balance, managing pain, and improving daily function can reduce the risk of falling and improve surgery outcomes. Despite this knowledge, there are no guidelines as to what type of rehabilitation is the best practice. Following a TKR surgery, patients still have difficulties doing their normal daily activities. Therefore, the aim of this study is to investigate the effects of a self-managed rehabilitation programme targeted to improve balance has on improving patient’s daily function.

Who can participate?
Adults aged 65-80 who have osteoarthritis and require a total knee replacement

What does the study involve?
After undergoing total knee replacement surgery, participants are randomly allocated to one of two groups. Those in the first group undergo standard rehabilitative exercises but also undergo self-managed exercises that are aimed at improving balance. This involves daily exercise (including walking) for around 10-20 minutes (building up to 34-40 minutes with time) for 12 weeks. Those in the second group continue with routine rehabilitation care. The same number of exercises are performed by both groups. Participants are assessed to see how well their knee works before the surgery and at eight and 14 weeks post-surgery.

What are the possible benefits and risks of participating?
Participants may benefit from the rehabilitation programmes. There are no notable risks with participating, however participants may experience some discomfort during the exercise training.

Where is the study run from?
University Hospital of Rion (Greece)

When is the study starting and how long is it expected to run for?
September 2011 to August 2015

Who is funding the study?
1. Queen Mary University (UK)
2. Musculoskeletal Association of Chartered Physiotherapists (UK)

Who is the main contact?
1. Mrs Maria Moutzouri (Scientific)
2. Professor Nigel Gleeson (Scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Maria Moutzouri

ORCID ID

http://orcid.org/0000-0002-7014-892X

Contact details

Physiotherapy Department
Technological Educational Institute Of Western Greece
Aigio
25100
Greece

Type

Scientific

Additional contact

Prof Nigel Gleeson

ORCID ID

Contact details

Queen Margaret University
Queen Margaret Drive
Edinburgh
EH21 6UU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1945

Study information

Scientific title

What are the effects of enhanced sensori-motor rehabilitation on indices of functional performance associated with patients following total knee replacement?

Acronym

ESMET

Study hypothesis

Sensori-motor rehabilitation training is better that usual care functional exercise training in patients' following knee replacement functional performance.

Ethics approval

1. The Institutional Committees of University Hospital of Patras, 22/08/2011 (Greece)
2. Queen Margaret University Edinburgh, 22/05/2012, ref: 7052/4-7-2011 (UK)

Study design

Single-centre interventional single blind prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Osteoarthritis

Intervention

After a total knee replacement, participants are randomly allocated to either the intervention rehabilitation group or the control rehabilitation group. Randomisation is done using a computer generated programme.

Intervention group: Participants undergo the early initialised, self-managed, enhanced sensori-motor programme as well as the standard rehabilitation. This includes participants being prescribed to perform the same number of exercises daily for 35-45 minutes which includes walking (progressively for 10-20 minutes) for six weeks. This is followed by a further six weeks of training (three times weekly for 45 minutes). Participants are taught by a physiotherapist all the required exercises that they should be doing and they are provided with a booklet that contains instructions. Participants who report signs of effusion or discomfort are given clinical help. Participants received support during the programme including encouragement to continue with the self-managed exercises.

Control group: Participants receive the usual level of care which consists of 15 exercises, focusing on improving knee motion and muscle strengthening. The same principles are followed in the case of discomfort or participants need clarification about exercises.

Participants in both groups are supervised by regular weekly phone-calls with a physiotherapist and/or orthopedic surgeon. Follow up includes a clinical evaluation at the end of the exercise programme, which is 14 weeks post-surgery. Another follow-up is planned for two years from the surgery and includes self-reproted questionnaires (KOOS, KOS- ADLS and SF-12) and takes place over the telephone.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Function is assessed using the Timed Up and Go Test at baseline, eight and 14 weeks post-surgery
2. Pain is measured using Visual Analogue Scale (VAS) at baseline, eight and 14 weeks post-surgery

Secondary outcome measures

1. Balance is measured using Biodex balance system at baseline, eight and 14 weeks post-surgery
2. Knee proprioception is measured using joint position error with a bubble inclinometer at baseline, eight and 14 weeks post-surgery
3. Muscle strength is measured using quadriceps maximum voluntary isometric contraction at 60 degrees of knee flexion with Primus Isokinetic dynamometer at baseline, eight and 14 weeks post-surgery
4. Muscle size is measured using rectus femoris cross sectional area with real time ultrasound at baseline, eight and 14 weeks post-surgery
5. Range of knee motion is measured using a goniometer while the patient is sitting at baseline, eight and 14 weeks post-surgery
6. Peak force of quadriceps with Spike electromyographic EMG during isometric contraction on the dynamometer at baseline, eight and 14 weeks post-surgery
7. Daily living function and quality of life are measured using the Knee injury and Osteoarthritis Outcome Score (KOOS), Knee Outcome Survey: Activities of Daily Living Scale (KOS-ADL )and the Short-Form 12 (SF1-2) at baseline, eight, 14 weeks and two years post-surgery

Overall trial start date

20/09/2011

Overall trial end date

30/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ambulatory patients with osteoarthritis (clinical and radiological findings of advanced osteoarthritis, 6-12 months length of wait for surgery)
2. Undergoing primary standardized cemented total knee replacement by the same surgeon
3. Aged 65-80 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Infection, or complications after total knee replacement (TKR)
2. Scheduled for TKR revision surgery
3. Having had any surgery in their lower limbs affecting their gait
4. Cardiovascular diseases, high blood pressure not controlled with medication
5. Neurological/ neuromuscular problems
6. Medical or other musculoskeletal problems that could affect ability to complete objective assessments

Recruitment start date

20/05/2012

Recruitment end date

30/05/2014

Locations

Countries of recruitment

Greece

Trial participating centre

University Hospital of Rion
Orthopedic Department Rio 265 04
Patras
26504
Greece

Sponsor information

Organisation

Queen Margaret University

Sponsor details

Queen Margaret Drive
Musselburgh
Edinburgh
EH21 6UU
United Kingdom
+44 131 474 0000
ngleeson@qmu.ac.uk

Sponsor type

University/education

Website

http://www.qmu.ac.uk/

Funders

Funder type

University/education

Funder name

Queen Margaret University

Alternative name(s)

Queen Margaret University, Edinburgh, QMU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

Musculoskeletal Association of Chartered Physiotherapists

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Systematic reviews and surveys to help with setting the protocol published in Medline journals.

IPD sharing plan:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository at the Technological Education Institute of Western Greece and can be accessed after the an application and approval from the Institute and from Queen Margaret University.

Intention to publish date

31/07/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes