University of Salford
Manchester, Greate Manchester, M6 6PU, United Kingdom
Location contact
Abdulaziz Alkanderi, PhD Candidate
CONTACT
Richard Jones, Professor
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07685496
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:
* Does footwear type affect gait characteristics such as gait speed, stride length, cadence, prosthetic foot clearance, and stance phase duration? * Does footwear type affect kinetic measures such as ground reaction forces and ankle power variables during walking? * Does footwear type affect in-shoe plantar pressure distribution? * Do participants perceive differences in comfort and stability between footwear conditions?
Participants will:
* Attend a laboratory-based gait analysis session at the University of Salford. * Complete 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. * Perform straight-line walking, incline and decline walking, and S-shaped walking tasks. * Wear reflective markers and in-shoe pressure sensors during testing. * Complete visual analogue scale ratings of comfort and stability for each footwear condition.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Manchester, Greate Manchester, M6 6PU, United Kingdom
Abdulaziz Alkanderi, PhD Candidate
CONTACT
Richard Jones, Professor
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory.
Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory.
Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory.
Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory.
Time frame: Baseline (single laboratory assessment)
Gait speed measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
Time frame: Baseline (single laboratory assessment)
Stride length measured using three-dimensional motion capture during walking under each footwear condition.
Time frame: Baseline (single laboratory assessment)
Cadence measured using three-dimensional motion capture during walking under each footwear condition.
Time frame: Baseline (single laboratory assessment)
Prosthetic foot clearance during swing phase measured using three-dimensional motion capture under each footwear condition.
Time frame: Baseline (single laboratory assessment)
Foot clearance time measured using three-dimensional motion capture under each footwear condition.
Time frame: Baseline (single laboratory assessment)
Ground reaction forces measured using force plate analysis during walking under each footwear condition.
Time frame: Baseline (single laboratory assessment)
Stance phase duration measured using three-dimensional motion capture and force plate analysis under each footwear condition.
Time frame: Baseline (single laboratory assessment)
Ankle power generated by the prosthetic foot measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
Time frame: Immediately after each footwear condition during the baseline laboratory assessment.
Participant-rated comfort for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Extremely Uncomfortable" to "Extremely Comfortable".
Time frame: Immediately after each footwear condition during the baseline laboratory assessment.
Participant-rated stability for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Very Unstable" to "Very Stable".
Contact information is provided by the study sponsor or research team.
University of Salford
Other
The Impact of Footwear on Gait in Unilateral Transtibial Amputees
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07652619
Transtibial Amputation, Transtibial Amputation - Unilateral
Raanana, Israel
View Trial DetailsNCT01821976
Transtibial Amputation
San Francisco, California, United States
View Trial DetailsNCT07592325
Lower Limb Amputation Below Knee, Transtibial Amputation
Clamart, France
View Trial DetailsNCT05989243
Transfemoral Amputation, Transtibial Amputation
Aurora, Colorado, United States
View Trial Details