Exploratory Functional Assessment After Lower Limb Amputation: Locomotion, Balance, Energy Performance and Strategies for Adapting to Orthopaedic Devices

NCT07094074 | Not Yet Recruiting

• 1 other identifier: ORNETTI 2025
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The general aim of this exploratory study is therefore to investigate and quantify the functional capacities of patients with lower limb amputations (transtibial and transfemoral), with no change in their management, and to describe any changes in these capacities. The volunteers included in this study will be testing new equipment, all of which will be CE-marked, and will therefore meet all the safety and performance conditions required for use by these patients (equipment that is likely to be prescribed as standard). These devices could benefit from current technological advances that could improve these patients' functional abilities. They will be chosen and adapted according to the volunteer's activity and current equipment. This is a local project of the CHU Dijon Bourgogne which will take place on the Technological Investigation Platform located at the Centre de Rééducation et de Réadaptation of the CHU Dijon Bourgogne. A maximum of 100 patients will take part in the study, divided into two sub-groups of between 5 and 50 patients, depending on the type of brace worn and the level of amputation. After the inclusion visit, each volunteer will undergo 2 assessment visits (the order of assessment of the devices will depend on randomisation) separated by 3 to 6 weeks. Follow-up is for a maximum of 14 weeks.

Conditions

Lower Limb Amputation

Outcome Measures

Primary Outcomes (1)

• Spontaneous walking speed before and after changing or modifying the equipment

  Up to 14 weeks

Study Arms (2)

No change of equipment at the inclusion visit

EXPERIMENTAL

Other: Walk tests; Other: Functional testing; Other: Balance analysis; Other: Quantified analysis of walking; Other: Questionnaires

Change of equipment at the end of the inclusion visit

EXPERIMENTAL

Other: Walk tests; Other: Functional testing; Other: Balance analysis; Other: Quantified analysis of walking; Other: Questionnaires

Interventions

Walk tests OTHER

* 200 m walk test * 2-minute walk test * 6-minute walk test

Change of equipment at the end of the inclusion visit; No change of equipment at the inclusion visit

Functional testing OTHER

Timed Up and Go test (TUG), Berg Balance Test (BBT), Choice Stepping Reaction Time (CSRT), Functional Reach Test (FRT)

Change of equipment at the end of the inclusion visit; No change of equipment at the inclusion visit

Balance analysis OTHER

Balance analysis

Change of equipment at the end of the inclusion visit; No change of equipment at the inclusion visit

Quantified analysis of walking OTHER

On flat ground, even on slopes and stairs

Change of equipment at the end of the inclusion visit; No change of equipment at the inclusion visit

Questionnaires OTHER

Houghton, Prosthetic Profile of the Amputees-Locomotion Capabilities Index (PPA-LCI), Activities-specific Balance Confidence scale (ABC), quality of life assessed by the SF-12

Change of equipment at the end of the inclusion visit; No change of equipment at the inclusion visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person who has given oral consent
• Patient able to understand simple commands and packaging instructions
• Male or female patient over 18 years of age
• Patient with a lower limb amputation, at tibial or femoral level

You may not qualify if:

• Person not affiliated to or not benefiting from a social security scheme
• Person subject to a legal protection measure (curatorship, guardianship)
• Person subject to a judicial protection measure
• Pregnant women, women in labour or breastfeeding mothers
• Adults who are incapable or unable to give their consent
• Subjects with disarticulated hips
• Subjects with serious associated pathologies having an impact on walking (other than amputation)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Paul ORNETTI

CONTACT

03 80 29 37 45; paul.ornetti@chu-dijon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: July 30, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: July 30, 2025

Record last verified: 2025-07