Condition category
Musculoskeletal Diseases
Date applied
07/01/2015
Date assigned
26/01/2015
Last edited
14/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Knee osteoarthritis is a major cause of chronic disability in older adults worldwide. The symptoms can be knee pain and morning stiffness. The patients might feel weakness in their thigh (quadriceps) muscles and have difficulty with the activities of daily living. The results of previous studies suggest that a simple walking programme can reduce pain and improve function and quality of life in patients with knee osteoarthritis. Retro walking might provide additional benefits to those associated with forward walking. The aim in this study is to investigate the effect of retro and forward walking on quadriceps muscle strength, pain, function, and mobility in individuals with knee osteoarthritis.

Who can participate?
Individuals with a diagnosis of knee osteoarthritis, aged 40–70 years old.

What does the study involve?
Individuals will be assigned to one of three groups (A, B and C). Group A will have two sessions (10 minutes each) of retro walking. Group B will have two sessions (10 minutes each) of forward walking. Patients in groups A and B will also receive a standard physiotherapy training programme. Group C will receive only a standard physiotherapy programme.

What are the possible benefits and risks of participating?
The benefits of the retro and forward walking programmes are improvements in knee pain, disability, and quality of life; another benefit of the retro walking programme is increase in the quadriceps strength. The risks of the programmes are minimum or none.

Where is the study run from?
Rehabilitation Research Chair, King Saud University (Saudi Arabia)

When is the study starting and how long is it expected to run for?
March 2014 to December 2015

Who is funding the study?
Rehabilitation Research Chair, King Saud University

Who is the main contact?
Mr Shahnawaz Anwer

Trial website

Contact information

Type

Public

Primary contact

Mr Shahnawaz Anwer

ORCID ID

Contact details

Building Number 24
College of Applied Medical Sciences
G095/1
Rehabilitation Research Chair
King Saud University
Riyadh
11433
Saudi Arabia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of a backward and forward walking programme on the strength, pain, function and mobility of the quadriceps in patients with knee osteoarthritis: a randomised controlled trial

Acronym

Study hypothesis

1. Retro and forward walking as an adjunct to a standard physiotherapy programme has significant effects on quadriceps muscle strength, pain, function, and mobility in patients with osteoarthritis knee.
2. There are significant differences in the effects of retro and forward walking as an adjunct to standard physiotherapy programme on quadriceps muscle strength, pain, function, and mobility in patients with osteoarthritis knee.

Ethics approval

Ethics subcommittee, Rehabilitation Research Chair, King Saud University, Riyadh, Saudi Arabia, 20/04/2014, RRC-2014-010

Study design

Double-blind randomised controlled 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

Knee osteoarthritis

Intervention

1. Group A participants will have two sessions (10 minutes each) of the retro walking programme with 5 minutes of warm up and cool down for 3 days a week for 6 weeks on a flat surface at their maximum pace along with a standard physiotherapy programme. They will gradually increase the walking time up to half an hour. Individuals will do ankle toe movements, hamstring stretching, gastrosoleus stretching and heel-raise exercises during warm up and cool down.
2. Group B participants will have two sessions (10 minutes each) of the forward walking programme with 5 minutes of warm up and cool down for 3 days a week for 6 weeks on a flat surface at their maximum pace along with a standard physiotherapy programme. They will gradually increase the walking time up to half an hour. Individuals will do ankle toe movements, hamstring stretching, gastrosoleus stretching and heel-raise exercises during warm up and cool down.
3. Group C participants (control) will receive only a standard physiotherapy programme.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Knee pain, measured with the Numeric Rating Scale
2. Knee function, measured with the Western Ontario and McMaster University Osteoarthris
Index
Outcomes will be measured at baseline and at the end of week 6.

Secondary outcome measures

1. Isometric quadriceps muscle strength, measured with a hand-held dynamometer
2. Mobility, measured with the timed up and go test
Outcomes will be measured at baseline and at the end of week 6.

Overall trial start date

01/03/2014

Overall trial end date

30/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Physician-diagnosed knee osteoarthritis, based on the American College of Rheumatology clinical and radiographic diagnostic criteria
2. Age 40–70
3. Kellgren-Lawrence grade of 1–3

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

69

Participant exclusion criteria

1. History of knee surgery within the past 3 months
2. Received physical therapy and an intra-articular injection for the knee within the past 3 months
3. History of a systemic arthritic condition
4. History of any other muscular, joint or neurological condition affecting the function of the lower limb

Recruitment start date

03/08/2014

Recruitment end date

30/10/2015

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

College of Applied Medical Sciences, King Saud University
Rehabilitation Research Chair College of Applied Medical Sciences King Saud University Building Number 24 G095/1 PO Box 10219
Riyadh
11433
Saudi Arabia

Sponsor information

Organisation

Rehabilitation Research Chair, King Saud University

Sponsor details

Building Number 24
College of Applied Medical Sciences
G095/1
Rehabilitation Research Chair
King Saud University
Riyadh
11433
Saudi Arabia

Sponsor type

Not defined

Website

Funders

Funder type

University/education

Funder name

Rehabilitation Research Chair, King Saud University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publish the study protocol in the coming months and the full study results in mid 2016.

Intention to publish date

30/06/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27072798

Publication citations

Additional files

Editorial Notes

14/04/2016: Publication reference added.