The biomechanical effect of rocker shoes in people with knee osteoarthritis
| ISRCTN | ISRCTN18313077 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18313077 |
| Secondary identifying numbers | Protocol v2 |
- Submission date
- 17/11/2015
- Registration date
- 23/11/2015
- Last edited
- 16/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Knee osteoarthritis (OA) is a condition that causes the knees to become painful and stiff. It is strongly affected by the way in which the knee joint is loaded during activities (i.e., the force put on the knee joint). Previous studies have found that footwear which alters the loading at the knee joint can reduce the pain. However, to date there has been relatively little research investigating the potential effects of rocker shoes. These shoes have a curved sole and are designed to rock the foot forward when walking. This rocking action may change the way in which the muscles of the leg activate and this may bring about a corresponding change in the way the joint is loaded. Before undertaking a large study, it is important to understand the effects of rocker footwear. Therefore, this study has been designed to find out how this type of footwear changes muscle activation patterns and how it may impact on joint loading in both individuals with knee osteoarthritis and healthy volunteers.
Who can participate?
Knee osteoarthritis patients and healthy volunteers aged between 40-85.
What does the study involve?
Each participant attends a single laboratory testing session at the University of Salford, during which they will wear different types of footwear (i.e., rocker footwear and a flexible OA shoe) whilst muscle activation and 3D motion data is collected.
What are the possible benefits and risks of participating?
Participants will experience different types of footwear, but we do not expect this to provide any significant benefits to participants. We are able to provide participants with travel expenses for participating. There are no risks of participating.
Where is the study run from?
University of Salford (UK)
When is the study starting and how long is it expected to run for?
November 2015 to November 2017
Who is funding the study?
University of Salford (UK)
Who is the main contact?
Ali Algarni
a.s.s.algarni@edu.salford.ac.uk
Contact information
Scientific
Centre for Health Sciences Research
Blatchford Building
Stratham Street
Salford
Manchester
M6 6PU
United Kingdom
 ORCID ID |
0000-0002-2434-732X |
|---|---|
| Phone | +44 (0)161 295 2273 |
| s.preece@salford.ac.uk |
Study information
| Study design | Randomised cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| 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 biomechanical effect of rocker shoes in people with knee osteoarthritis: a randomised cross-over trial |
| Study objectives | This study will therefore compare the biomechanical effect of this specific design of rocker shoe, with both a flexible shoe and also a standard control shoe. |
| Ethics approval(s) | UK NHS ethics committee of East Midlands - Derby, 17/11/2015, REC ref: 15/EM/0502 |
| Health condition(s) or problem(s) studied | Knee osteoarthritis |
| Intervention | Single-centre trial in which we plan to investigate the biomechanical effects of different footwear. This will be achieved with a laboratory cross-over study at the University of Salford, during which participants will wear the different types of footwear (rocker footwear and a flexible OA shoe) during a single testing session whilst biomechanical data (muscle activation and 3D motion) is collected. |
| Intervention type | Other |
| Primary outcome measure | Muscular co-contraction of the quadriceps and hamstrings and the quadriceps and gastrocnemius, derived from electromyography (EMG) data collected from the specified muscles during walking |
| Secondary outcome measures | 1. The knee extensor moment outcome calculated from force and kinematic (3D motion) data collected during walking 2. The centre of mass position derived from full-body 3D motion data during walking |
| Overall study start date | 23/11/2015 |
| Completion date | 23/11/2017 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 with OA and 30 healthy volunteers |
| Key inclusion criteria | 1. Age range 40-85 (upper age limit due to the amount of walking involved in the study) 2. Ability to stand and walk independently 3. Speak and understand written English 4. Ability to walk without any walk assistive for at least 250 m 5. Clinical diagnosis of knee OA according to American College of Rheumatology (ACR) (Altman et al. 1986) (if they are a participant with knee OA) 6. Pain for at least 6 months' duration (if they are a participant with knee OA) 7. Pain or difficulty in rising from sitting and/or climbing stairs (if they are a participant with knee OA) |
| Key exclusion criteria | 1. Complex pain conditions such as diabetic neuropathic pain, fibromyalgia 2. Have had previous surgery to the lower limb 3. BMI >33 since it is not possible to perform accurate measurements on individuals with excess adipose tissue 4. Lower limb arthroplasty 5. Any systemic inflammatory disorders, such as rheumatoid arthritis 6. Any balance disorders which may increase the risk of a fall |
| Date of first enrolment | 23/11/2015 |
| Date of final enrolment | 23/11/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Blatchford Building
University of Salford
Salford
Manchester
M6 6PU
United Kingdom
Sponsor information
Research organisation
Allerton Building
University of Salford
Salford
Manchester
M6 6PU
United Kingdom
"ROR" |
https://ror.org/01tmqtf75 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 14/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The results will be submitted for publication in biomechanics and osteoarthritis journals |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Thesis results | 18/12/2018 | 16/08/2022 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/08/2022: A link to a thesis was added.
14/05/2021: The intention to publish date has been added.
