Towards a smart and intuitive controlled MyLeg prosthesis: acquisition of intramuscular electromyography for motion intention detection. A pilot study.

Completed

• Conditions: chirurgische en medische verrichtingen: zenuwstelsel therapeutische verrichtingen; transfemoral amputation; upper leg amputation; 10005944

• Registration Number: NL-OMON49529
• Lead Sponsor: Revalidatiecentrum Het Roessingh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

Transfemoral amputees with targeted muscle reinnervation:
- Aged 18 or above.
- Unilateral transfemoral amputation.
- At least one year after osseointegration implant surgery.
- At least six months after TMR surgery and visible contractions (by
ultrasound) of the TMR sites.
- Functional level defined as Medicare Functional Classification Level 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
1 hour including breaks.

Transfemoral amputees:
- Aged 18 or above.
- Unilateral transfemoral amputation.
- At least one year after osseointegration implant surgery.
- Functional level defined as Medicare Functional Classification Level K2 to K4
[12]; see description above.
- Able to perform low to moderate vigorous physical activity for a duration of
1 hour including breaks.

Able-bodied:
- Aged 18 or above.
- Able to perform low to moderate vigorous physical activity for a duration of
1 hour including breaks.

Exclusion Criteria

Transfemoral amputees (with targeted muscle reinnervation):
- Not willing to consent to participate in the study.
- Other musculoskeletal problems influencing walking abilities.
- Stump problems: untreated skin conditions, wounds, infections, or problems
affecting walking ability.
- Taking coumarin-derivatives and having an INR > 3.0. (Subjects with an INR *
3.0 or using NOACs will be included in the study, and informed about the
slightly increased bleeding risk.)
- Have had amputation because of infection and/or bad wound healing.

Able-bodied:
- Not willing to consent to participate in the study.
- Musculoskeletal problems influencing walking ability.
- Taking coumarin-derivatives and having an INR > 3.0. (Subjects with an INR *
3.0 or using NOACs will be included in the study, and informed about the
slightly increased bleeding risk.)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> The main study parameters are the misclassification rates of a classifier,<br /><br>while varying the input (iEMG versus sEMG data, TMR versus non-TMR data). In<br /><br>addition, the corresponding confusion matrixes will provide insight in what the<br /><br>classification model is getting right (for instance the difference between<br /><br>walking and ascending stairs) and what types of errors it makes (for instance<br /><br>often confusing slow walking with walking on uneven terrain).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are:<br /><br>- Average muscle activation pattern of the TMR site and the original site of<br /><br>innervation during a gait cycle of activities of daily life (normal walking,<br /><br>stair ascent, ramp descend, etc.).<br /><br>- Muscle activation patterns of intramuscular TMR site and the reconstructed<br /><br>version from the multi-array sEMG (after extensive signal analysis).<br /><br>- Bland-Altman plots and the Root Mean Square Error to estimate a<br /><br>goodness-of-fit for joint angles prediction based on sEMG and iEMG.</p><br>