Exploratory Functional Assessment After Lower Limb Amputation: Locomotion, Balance, Energy Performance and Strategies for Adapting to Orthopaedic Devices
NCT ID: NCT07094074
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-09-30
2031-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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No change of equipment at the inclusion visit
Walk tests
* 200 m walk test
* 2-minute walk test
* 6-minute walk test
Functional testing
Timed Up and Go test (TUG), Berg Balance Test (BBT), Choice Stepping Reaction Time (CSRT), Functional Reach Test (FRT)
Balance analysis
Balance analysis
Quantified analysis of walking
On flat ground, even on slopes and stairs
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
Change of equipment at the end of the inclusion visit
Walk tests
* 200 m walk test
* 2-minute walk test
* 6-minute walk test
Functional testing
Timed Up and Go test (TUG), Berg Balance Test (BBT), Choice Stepping Reaction Time (CSRT), Functional Reach Test (FRT)
Balance analysis
Balance analysis
Quantified analysis of walking
On flat ground, even on slopes and stairs
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
Interventions
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Walk tests
* 200 m walk test
* 2-minute walk test
* 6-minute walk test
Functional testing
Timed Up and Go test (TUG), Berg Balance Test (BBT), Choice Stepping Reaction Time (CSRT), Functional Reach Test (FRT)
Balance analysis
Balance analysis
Quantified analysis of walking
On flat ground, even on slopes and stairs
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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ORNETTI 2025
Identifier Type: -
Identifier Source: org_study_id
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