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Towards MY smart and intuitive controlled LEG prosthesis

Towards MY smart and intuitive controlled LEG prosthesis: acquisition of electromyography for motion intention detection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27197
Enrollment
70
Registered
2018-10-31
Start date
2019-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

transfemoral amputation, leg prosthesis, intuitive control, EMG, intention detection tranfemorale amputatie, beenprothese, intuïtieve controle, EMG, intentie detectie

Interventions

None listed

Sponsors

Roessingh Research and Development
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Individuals without an amputation In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Aged 18 or above. - Able to perform low to moderate vigorous physical activity for a duration of 3 hours including breaks. Individuals with an amputation In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Aged 18 or above - Unilateral transfemoral amputation or knee disarticulation. - Functional level from K2 to K4 o Level 2: The patient has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator. o Level 3: The patient has the ability or potential for ambulation with variable cadence. Typical of the community ambulatory who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion. o Level 4: The patient has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete. - Able to perform low to moderate vigorous physical activity for a duration of 3 hours including breaks. - At least one year after amputation.

Exclusion criteria

Exclusion criteria: Individuals without an amputation: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Not willing to consent to participate in the study. - Musculoskeletal problems influencing walking ability. Individuals with an amputation: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Not willing to consent to participate in the study. - Other musculoskeletal problems influencing walking ability. - Stump problems/bad socket fitting

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the misclassification rate of a classifier. The misclassification rate of the classifier that is based on biplor EMG and HD-EMG will be compared. In addition, misclassification rates of classifiers developed with different techniques will also be compared.

Secondary

MeasureTime frame
Secundary study parameters are: - The misclassification rate for unsupervised algorithms. Unsupervised algorithms will also be compared to supervised algorithms. To determine the effect of repeated measurements on the robustness of the classifier. - The effect of additional sensor information on misclassification rate by using the raw IMU sensor data from the Xsens suit. This information is recorded during measurements anyway, as Xsens uses this information in their biomechanical model to reconstruct movements.

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)