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The goal of this interventional study is to learn how different types of footwear affect gait, stability, comfort, and walking performance in adults with a unilateral transtibial amputation who use a lower limb prosthesis.
The main questions it aims to answer are:
Participants will:
People with transtibial amputations often rely on footwear that is comfortable, practical, and compatible with their prosthetic device. Although footwear is known to influence walking mechanics in the general population, there is limited evidence regarding its effects on gait in people who use lower limb prostheses. This study aims to investigate the impact of different footwear types on gait performance, stability, and comfort in adults with unilateral transtibial amputations.
Fifteen participants aged 18 to 65 years who use an energy-storing-and-return (ESAR) prosthetic foot will be recruited. Participants must be able to walk independently without a walking aid.
Each participant will attend a laboratory-based testing session at the University of Salford. Reflective markers will be placed on the body and prosthesis to allow three-dimensional motion analysis. Participants will also wear an in-shoe pressure measurement system.
Participants will complete a series of walking tasks while wearing four footwear conditions: their own preferred footwear, an Oxford shoe, a running/walking shoe, and a shoe with a forefoot rocker profile. The order of the footwear conditions will be randomised. Walking tasks will include straight-line walking, walking on an incline and decline, and walking along an S-shaped path involving turns.
Outcome measures will include gait speed, stride length, cadence, prosthetic foot clearance, stance phase duration, ground reaction forces, ankle power variables, and plantar pressure measurements. Participants will also rate the comfort and stability of each footwear condition using visual analogue scales and provide additional comments about their experience.
Data will be analysed to determine whether footwear type influences gait performance, stability, and perceived comfort in people with unilateral transtibial amputations. The findings may contribute to future clinical guidance and footwear recommendations for prosthetic users.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Own Footwear | Active Comparator | Participants complete walking and balance assessments while wearing their own regularly used footwear. |
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| Oxford Shoe | Experimental | Participants complete walking and balance assessments while wearing a standard Oxford shoe. |
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| Walking/Running Shoe | Experimental | Participants complete walking and balance assessments while wearing a walking/running shoe. |
|
| Rocker Shoe | Experimental | Participants complete walking and balance assessments while wearing a rocker shoe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Own Footwear | Device | Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gait speed | Gait speed measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition. | Baseline (single laboratory assessment) |
| Stride length | Stride length measured using three-dimensional motion capture during walking under each footwear condition. | Baseline (single laboratory assessment) |
| Cadence | Cadence measured using three-dimensional motion capture during walking under each footwear condition. | Baseline (single laboratory assessment) |
| Prosthetic foot clearance during swing phase | Prosthetic foot clearance during swing phase measured using three-dimensional motion capture under each footwear condition. | Baseline (single laboratory assessment) |
| Foot clearance time | Foot clearance time measured using three-dimensional motion capture under each footwear condition. | Baseline (single laboratory assessment) |
| Ground reaction forces | Ground reaction forces measured using force plate analysis during walking under each footwear condition. | Baseline (single laboratory assessment) |
| Stance phase duration | Stance phase duration measured using three-dimensional motion capture and force plate analysis under each footwear condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived footwear comfort | Participant-rated comfort for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Extremely Uncomfortable" to "Extremely Comfortable". | Immediately after each footwear condition during the baseline laboratory assessment. |
| Perceived footwear stability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdulaziz Alkanderi, PhD Candidate | Contact | +447443673361 | A.Alkanderi1@edu.salford.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Salford | Manchester | Greate Manchester | M6 6PU | United Kingdom |
The study team has not yet made a final decision regarding the sharing of individual participant data (IPD). Any future data sharing will be subject to participant consent, ethical approval requirements, institutional policies, and data protection regulations. If data are shared, all information will be de-identified to protect participant confidentiality.
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Each participant will complete walking tasks under multiple footwear conditions, including their own footwear, an Oxford shoe, a walking/running shoe, and a rocker shoe. All participants will experience all footwear conditions, allowing within-subject comparison of gait and stability outcomes.
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| Oxford Shoe | Device | Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory. |
|
| Walking/Running Shoe | Device | Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory. |
|
| Rocker Shoe | Device | Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory. |
|
| Baseline (single laboratory assessment) |
| Ankle power generated by the prosthetic foot | Ankle power generated by the prosthetic foot measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition. | Baseline (single laboratory assessment) |
Participant-rated stability for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Very Unstable" to "Very Stable". |
| Immediately after each footwear condition during the baseline laboratory assessment. |