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NCT Number: NCT06635655

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

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.

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Key information

Conditions

Lower Limb Amputation Above Knee (Injury) Wounds and Injuries

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. Goal Attainment Scale (GAS)

    Time frame: 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 outcomes

  1. L-test and Dual-task L-test

    Time frame: Initial visit, at 4 weeks, and at 8 weeks

    To assess locomotor capacity in divided attention on a short period

  2. Two-minute walk test (2MWT) and 2MWT in divided attention

    Time frame: Initial visit, at 4 weeks, and at 8 weeks

    to assess locomoto capacity and mental worload during a 2-minute exercise

  3. Activity Balance Confidence Scale (ABC-scale)

    Time frame: at 4 weeks, and at 8 weeks

    Patient reported balance confidence Scale from 0% (minimum) to 100% (maximum), the higher the better.

  4. Prosthesis Evaluation Questionnaire (PEQ-A)

    Time frame: at 4 weeks, and at 8 weeks

    Patient reported satisfaction Visual Analog Scale from 0% (minimum) to 100% (maximum) The higher the better

  5. Stumbles and falls

    Time frame: at 4 weeks, and at 8 weeks

    Self-reported number The lower the better

Study contacts

Contact information is provided by the study sponsor or research team.

Renaud Urbinelli

CONTACT

[email protected]

0033658687286

Sponsors and collaborators

Lead sponsor

Proteor Group

Industry

Registry information

Official study title

Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation

Acronym: INCREMENT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2024
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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