Primary Objective:Develop improved movement prediction for transfemoral amputees by application of iEMG (in comparison to sEMG), and moreover to determine to what extent TMR can contribute to this improvement.Secondary Objective(s):- Verify if the…
ID
Source
Brief title
Condition
- Other condition
- Bone and joint therapeutic procedures
Synonym
Health condition
chirurgische en medische verrichtingen: zenuwstelsel therapeutische verrichtingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the misclassification rates of a classifier,
while varying the input (iEMG versus sEMG data, TMR versus non-TMR data). In
addition, the corresponding confusion matrixes will provide insight in what the
classification model is getting right (for instance the difference between
walking and ascending stairs) and what types of errors it makes (for instance
often confusing slow walking with walking on uneven terrain).
Secondary outcome
The secondary study parameters are:
- Average muscle activation pattern of the TMR site and the original site of
innervation during a gait cycle of activities of daily life (normal walking,
stair ascent, ramp descend, etc.).
- Muscle activation patterns of intramuscular TMR site and the reconstructed
version from the multi-array sEMG (after extensive signal analysis).
- Bland-Altman plots and the Root Mean Square Error to estimate a
goodness-of-fit for joint angles prediction based on sEMG and iEMG.
Background summary
The control of prosthetic legs is not intuitive. Where individuals without an
amputation can flex and extend their joints voluntarily, individuals with an
amputation cannot do that but have to use movements of the residual leg (stump)
to control the movement of the prosthetic device. To realize intuitive control,
researchers are working to incorporate muscle activity, as measured with
surface electromyography (sEMG), in prosthetic leg control. By investigating
muscle activity one can predict the activity somebody is (about to be)
performing, like walking on a ramp or ascending stairs. Based on the activity
that is about to be performed the prosthesis can be set to optimal
biomechanical properties that are needed to successfully complete the activity.
The state-of-the-art sEMG-based prediction, with a misclassification rate of
7.9% [1], has a high risk of stumble and falls. For this reason, it is still
not good enough for clinical application. Therefore, this pilot study explores
the use of intramuscular EMG (iEMG) and targeted muscle reinnervation (TMR) to
improve prediction results. The hypothesis is that iEMG will improve prediction
results because of the more consistent electrode sites, reduced crosstalk, and
acquisition of signals from deeply located muscles. Further, TMR will provide
additional muscle signals which is valuable extra information for movement
prediction.
[1] L. J. Hargrove et al., *Intuitive control of a powered prosthetic leg
during ambulation: A randomized clinical trial,* JAMA - J. Am. Med. Assoc.,
vol. 313, no. 22, pp. 2244*2252, 2015.
Study objective
Primary Objective:
Develop improved movement prediction for transfemoral amputees by application
of iEMG (in comparison to sEMG), and moreover to determine to what extent TMR
can contribute to this improvement.
Secondary Objective(s):
- Verify if the muscle activation patterns of the phantom lower leg (TMR sites)
are similar to the activation patterns in a lower leg of an individual without
an amputation.
- Investigate if TMR activation patterns, as derived from intramuscular TMR
sites (located deep), can be extracted from the multi-array sEMG data.
- Explore the possibilities of direct control with both iEMG and sEMG, with
presence of TMR.
Study design
Observational study (pilot).
Study burden and risks
The burden and risks associated with participation are limited to a minimum,
since the activities which will be performed by the participants represent
functional and familiar movements and the tasks are performed only within the
scope of the subject*s ability. Furthermore, most measurements used in this
study (kinematics, sEMG) are non-invasive and involve no risks to the
participants in any way. The only invasive measure is the intramuscular EMG via
fine-wires, which might cause minor discomfort but is routinely used in
clinical studies. Participants will not directly benefit from participation.
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Listed location countries
Age
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.)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75528.091.20 |
| Other | nog onbekend |