Study on the effects of footwear on pain and fatigue in the lower extremities
| ISRCTN | ISRCTN10672939 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10672939 |
| Secondary identifying numbers | T/3/UN34.20/PT.01.03/2024 |
- Submission date
- 29/01/2025
- Registration date
- 01/02/2025
- Last edited
- 31/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Lower extremity pain and fatigue are common issues affecting mobility and quality of life. This study aims to evaluate the efficacy of health shoes with Pillow Concept technology in reducing pain and fatigue and improving balance and satisfaction among adults with lower limb discomfort.
Who can participate?
Adults aged 25-60 years who have experienced foot or lower limb pain or fatigue for more than one month and able to walk independently.
What does the study involve?
Participants will be randomly assigned to two groups:
1. An intervention group using health shoes with Pillow Concept technology.
2. A control group using their regular footwear.
Participants will wear the assigned shoes for 4 weeks, walking approximately 3000 steps (or 30 minutes) daily. Pain, fatigue, balance, and satisfaction will be assessed at baseline, week 2, and week 4.
What are the possible benefits and risks of participating?
Participants may experience a reduction in pain and fatigue, improved balance, and increased satisfaction with footwear. Risks are minimal but may include mild discomfort or adjustment issues when using the new shoes ( in the intervention group).
Where is the study run from?
The study will be conducted at the Faculty of Medicine, Universitas Negeri Yogyakarta, Indonesia.
When is the study starting and how long is it expected to run for?
January 2025 to January 2026
Who is funding the study?
PT. Chosen Mitra Abadi (Indonesia)
Who is the main contact?
Dr Muhammad Ikhwan Zein, dr_ichwanz@uny.ac.id
Contact information
Principal Investigator
Faculty of Medicine, Universitas Negeri Yogyakarta (Jl. Colombo No.1 Karangmalang Yogyakarta)
Yogyakarta
55281
Indonesia
 ORCID ID |
0000-0003-3728-5065 |
|---|---|
| Phone | +62 8111286520 |
| fk@uny.ac.id |
Public, Scientific
Faculty of Medicine, Universitas Negeri Yogyakarta (Jl. Colombo No.1 Karangmalang Yogyakarta)
Yogyakarta
55281
Indonesia
| Phone | +62 813-3316-0801 |
|---|---|
| lailyrahmawati@uny.ac.id |
Study information
| Study design | Randomised controlled trial with a parallel-group design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community, Workplace, Other |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Randomised controlled trial of health shoes with pillow concept technology to reduce pain and fatigue in the lower extremities |
| Study acronym | STEPFIT |
| Study objectives | We hypothesize that a four-week use of shoes featuring Pillow Concept technology will significantly reduce pain and fatigue in the feet and lower limbs compared to regular shoes. Our secondary hypothesis is that participants in the intervention group will report greater user satisfaction and comfort during daily activities. |
| Ethics approval(s) |
Approved 01/01/2025, Ethics committee at Directorate of Research and Community Service, Universitas Negeri Yogyakarta (Universitas Negeri Yogyakarta, Jl. Colombo No.1 Karang Malang, Sleman, Yogyakarta, 55281, Indonesia; +62 274586168, ext. 262, 550839; komisi.etik@uny.ac.id), ref: T/6.96/UN34.9/KP.06.07/2024 |
| Health condition(s) or problem(s) studied | Lower extremity pain and fatigue |
| Intervention | Group 1 (Intervention): Shoes with Pillow Concept Technology, designed to reduce vibrations during walking to alleviate discomfort, pain, and fatigue in the lower extremities. The intervention period lasts for 4 weeks, with participants walking 3000 steps (or 30 minutes) daily. Group 2 (Control): Regular shoes used by participants in their daily activities, also worn for the same duration. The subjects will be randomized with a 1:1 allocation ratio using an online software application (Sealed Envelope™) and assigned to either the intervention group (shoes with pillow technology) or the control group (using their daily shoes). The coordinating researcher (MIZ) will manage the allocation process and remain blinded to the assigned intervention. An unblinded research assistant who is not part of the research team will deliver the randomization results and inform the subjects of their assigned intervention. The researchers conducting and interpreting the analysis will remain blinded to group allocation until all outcome analyses have been completed. No changes will be made to the interpretation after the analysis results are unblinded. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bocorocco shoes with Pillow Concept technology |
| Primary outcome measure | 1. Foot health is measured using the Foot Health Assessment Questionnaire at baseline, 2-week follow-up, and 4-week follow-up 2. Pain intensity is measured using the Numerical Rating Scale (NRS) at baseline, 2-week follow-up, and 4-week follow-up 3. Pressure pain threshold is measured using a dolorimeter at baseline, 2-week follow-up, and 4-week follow-up 4. Balance is measured using the Single Leg Stance Test at baseline, 2-week follow-up, and 4-week follow-up 5. Functional reach is measured using the Functional Reach Test at baseline, 2-week follow-up, and 4-week follow-up |
| Secondary outcome measures | User satisfaction for shoes will be assessed using Likert scale at 4 weeks |
| Overall study start date | 01/01/2025 |
| Completion date | 01/01/2026 |
Eligibility
| Participant type(s) | Patient, Other |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 140 participants (70 in the intervention group and 70 in the control group). |
| Key inclusion criteria | 1. Adults aged between 25-60 years. 2. Pain or fatigue in the feet or lower extremities lasting more than one month. 3. Able to walk independently without assistance. |
| Key exclusion criteria | 1. History of foot or lower limb surgery within the past 6 months. 2. Neurological disorders affecting walking ability. 3. Use of medications that influence pain perception. |
| Date of first enrolment | 14/02/2025 |
| Date of final enrolment | 30/10/2025 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Yogyakarta
55281
Indonesia
Sponsor information
University/education
Faculty of Medicine, Universitas Negeri Yogyakarta (Jl. Colombo No.1 Karangmalang Yogyakarta)
Yogyakarta
55281
Indonesia
| Phone | +62 82137176969 |
|---|---|
| fk@uny.ac.id | |
| Website | https://fk.uny.ac.id/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results will be published in high-impact, peer-reviewed journals and presented at relevant academic conferences. Findings will also be shared with participants and stakeholders via institutional reports. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upen request from : dr. Muhammad Ikhwan Zein, email : dr_ichwanz@uny.ac.id |
Editorial Notes
29/01/2025: Ethics committee at Directorate of Research and Community Service, Universitas Negeri Yogyakarta.
