NCT07094074

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Walk tests	* 200 m walk test * 2-minute walk test * 6-minute walk test
OTHER	Functional testing	Timed Up and Go test (TUG), Berg Balance Test (BBT), Choice Stepping Reaction Time (CSRT), Functional Reach Test (FRT)
OTHER	Balance analysis	Balance analysis
OTHER	Quantified analysis of walking	On flat ground, even on slopes and stairs
OTHER	Questionnaires	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

Timeline

• Start date: 2025-09-01
• Primary completion: 2031-01-01
• Completion: 2031-01-01
• First posted: 2025-07-30
• Last updated: 2025-07-30