Actively Recruiting
Impact of a Prosthetic Foot With Adjustable Heel Height on Physical Appearance and Participation: a Randomized Crossover Trial
Led by Otto Bock France SNC · Updated on 2025-11-25
30
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess how a prosthetic foot with an adjustable heel height affects physical appearance and social participation in adults with major lower limb amputations. The study addresses the challenge that most prosthetic feet have a fixed heel height, which limits users to wearing shoes with the same heel height. Being able to choose different shoes freely is important for coping with physical disability and maintaining lifestyle preferences. Participants will use two types of prosthetic feet in a randomized order. One device is the Taleo Adjust foot, which features a hydraulic ankle allowing adjustable heel heights from 0 to 7 cm to match different shoe types without compromising walking quality. The other is the participant's usual energy storage and return (ESR) foot with a fixed heel height. Each foot will be worn for 30 days, with participants either starting with the Taleo Adjust foot then switching to their usual foot, or vice versa. During the study, participants will be assessed using questionnaires and scales that measure appearance satisfaction, functional ability, psychosocial impact, device satisfaction, quality of life, mobility, and socket comfort. The primary outcome is the Prosthetic Evaluation Questionnaire - Appearance scale after 30 days of use for each foot. The study includes monitoring participant experiences and measuring how the adjustable heel foot influences daily activities and social participation over the two 30-day periods.
CONDITIONS
Brief Title
Study on a Prosthetic Foot With Adjustable Heel Height
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient with a major lower limb amputation
- Life plan includes movement inside buildings other than home, outside the home, and other related activities
- Using an Energy Storage and Return (ESR) prosthetic foot for at least 3 months
- Wishes to walk with shoes of different heel heights or barefoot
You will not qualify if you...
- Patient with a high impact activity level such as sports
- Patient with hip disarticulation or equivalent
- Unstabilised residual limb or unsuitable socket
- Cannot be fitted with Taleo Adjust foot due to weight over 115 kg, foot size outside 22-28, or mounting height less than 118 mm
- Usual foot has heel height adjustment system
- Unavailable for study duration or unable to understand instructions and questionnaires in French
- Currently participating in another study
- Patient in an emergency situation or pregnant woman
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 60 days
Participants are fitted with the Taleo Adjust prosthetic foot with adjustable heel height and use it for 30 days, then fitted with their usual prosthetic foot for 30 days, or vice versa.
2 visits (one fitting visit for each prosthetic foot)
Trial Site Locations
Total: 5 locations
1
CH Cornouaille
Concarneau, France
Actively Recruiting
2
CHU Grenoble
Échirolles, France
Actively Recruiting
3
IRR Louis Pierquin
Nancy, France
Actively Recruiting
4
CRRF La Tourmaline
Saint-Herblain, France
Actively Recruiting
5
Institut Merle d'Aubigné
Valenton, France
Actively Recruiting
Research Team
A
Aurelie LACROIX
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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