The primary objectives of the different substudies are: 1) to identify the level and behavior of passive forces in the arm2) compare different weight and joint impedance compensation strategies of the motorized arm support3) evaluate the overall…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders congenital
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sub-study 1) • Torque-angle values
Sub-study 2) Comparison of the three different compensation strategies:
• Surface electromyography (sEMG) amplitude
• Joint angles (according to SEA)
• Residual interaction forces (according to the force sensor on interface
sleeve)
Sub-study 3) Feasibility and usability of the arm support vs. no arm support:
• Surface electromyography (sEMG) amplitude
• Performance of the Upper Limb (PUL)
• Reachable workspace with Vicon upper limb model
• Fatigue (sEMG with respect to maximal measured value in no arm support
condition and RPE)
• Usability (SUS and self-developed questionnaire)
Secondary outcome
Sub-study 1)
• Maximal passive ROM (limit)
• Maximal torque in end movement (limit)
Sub-study 2)
• Fatigue (RPE)
• Perceived workload (NASA Task-Load-Index)
Sub-study 3)
• Design requirements of the motorized arm support
Background summary
Duchenne muscular dystrophy (DMD) is a progressive X-linked disorder
characterized by progressive muscle wasting and weakness, resulting in loss of
functional abilities. Until now no cure is found but the life expectancy is
increased from around 14 years to over 35 years. Therefore, the lifespan
wherein patients with DMD need support of their upper extremity to stay more
independent in activities of daily living (ADL) becomes longer and more
important to improve their quality of life. In a more impaired phase, these
patients can benefit from a motorized arm support to assist in ADL. Because
there is a low percentage active exoskeleton of all commercial available
exoskeletons, a new motorized arm support is developed which we want to test in
a small DMD population.
Study objective
The primary objectives of the different substudies are:
1) to identify the level and behavior of passive forces in the arm
2) compare different weight and joint impedance compensation strategies of the
motorized arm support
3) evaluate the overall performance (feasibility and usability) of the
developed prototype in boys and men with DMD.
Study design
This is an explorative pilot study
Intervention
A prototype of a motorized arm support is developed. It can move the right arm
of the participant in four degrees of freedom (three in shoulder, one in elbow)
by Series Elastic Actuators. The arm support is attached to a support frame,
which can be placed around participants. It is not yet applicable in daily
life, but tested in an investigational, controlled setting.
Study burden and risks
The risks associated to the use of the arm support are minimalised (see
extensive risk-analysis which is performed) and the tasks that we ask the
participants to perform are movements they make in daily life and have
therefore no extra burden. Because the study is split in different parts, the
amount of time participation takes (4 visits taking between 2 and 4 hours) can
be seen as a burden. However, the benefits of the steps that can be taken in
the development of a motorized arm support are high.
Reinier postlaan 4
Nijmegen 6500 HB
NL
Reinier postlaan 4
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
DNA established diagnosis of DMD
Brooke scale 4
Age >= 16 years
Able to grab objects
Able to sit stable upright without arm support
Body dimensions are compatible with the device (e.g. forearm circumference
smaller than 31 cm; upper arm length between 23.5 and 33.5 cm)
Sufficient language skills and normal cognition
Exclusion criteria
Injury of the right upper extremity
Active electrical implants (e.g. pacemaker, cochlear implant)
Epilepsy
Wheelchair height at shoulder location above shoulder that cannot be tilted
posterior.
Design
Recruitment
Medical products/devices used
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 | NL79738.000.23 |