Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.

Recruiting

• Conditions: Lower Limb Amputation Above Knee (Injury)

• Registration Number: NCT06635655
• Lead Sponsor: Proteor Group

Brief Summary

New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life. Following users feedback, it is desirable to better understand why and how mental workload is impacted by new technologies or features. This clinical investigation will try to measure a difference between different prosthetic systems, in lab and in daily life.

Detailed Description

Multicentric, national, observational, prospective study, using AB type SCED.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-10
• Study Start: 2024-11-04
• Primary Completion: 2025-01-03
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• above-knee lower limb amputation
• using an above-knee prosthesis with prosthetic knee and foot
• eligible to use Synsys
• able to design therapeutic objectives for the GAS
• having a smartphone

Read More

Exclusion Criteria

• protected person
• pregnant or breast-feeding lady
• knee-to-ground height lower than 43cm
• weighting more than 125kg
• using their prosthesis for less than 2 weeks
• not covered by health insurance
• aged less than 18 or more than 84 years old
• bilateral amputee or hip disarticulated

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Goal Attainment Scale (GAS)	From enrollment to the end of treatment at 8 weeks	Scale from -3 to +2. The higher the better.; -3 being a deterioration, -2 being the baseline, 0 the objective, +2 the maximum

Secondary Outcome Measures

Name	Time	Method
L-test and Dual-task L-test	Initial visit, at 4 weeks, and at 8 weeks	To assess locomotor capacity in divided attention on a short period
Two-minute walk test (2MWT) and 2MWT in divided attention	Initial visit, at 4 weeks, and at 8 weeks	to assess locomoto capacity and mental worload during a 2-minute exercise
Activity Balance Confidence Scale (ABC-scale)	at 4 weeks, and at 8 weeks	Patient reported balance confidence Scale from 0% (minimum) to 100% (maximum), the higher the better.
Prosthesis Evaluation Questionnaire (PEQ-A)	at 4 weeks, and at 8 weeks	Patient reported satisfaction Visual Analog Scale from 0% (minimum) to 100% (maximum) The higher the better
Stumbles and falls	at 4 weeks, and at 8 weeks	Self-reported number The lower the better

Trial Locations

Locations (1)

Multiple sites; 🇫🇷 Multiple Locations, France