Motorized arm support augmenting upper extremity function of people with Duchenne Muscular Dystrophy

Not yet recruiting

• Conditions: DMD; 10028302; Duchenne muscular dystrophy; 10028396

• Registration Number: NL-OMON53514
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 5

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sub-study 1) • Torque-angle values<br /><br>Sub-study 2) Comparison of the three different compensation strategies:<br /><br>• Surface electromyography (sEMG) amplitude<br /><br>• Joint angles (according to SEA)<br /><br>• Residual interaction forces (according to the force sensor on interface<br /><br>sleeve)<br /><br>Sub-study 3) Feasibility and usability of the arm support vs. no arm support:<br /><br>• Surface electromyography (sEMG) amplitude<br /><br>• Performance of the Upper Limb (PUL)<br /><br>• Reachable workspace with Vicon upper limb model<br /><br>• Fatigue (sEMG with respect to maximal measured value in no arm support<br /><br>condition and RPE)<br /><br>• Usability (SUS and self-developed questionnaire)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Sub-study 1)<br /><br>• Maximal passive ROM (limit)<br /><br>• Maximal torque in end movement (limit)<br /><br>Sub-study 2)<br /><br>• Fatigue (RPE)<br /><br>• Perceived workload (NASA Task-Load-Index)<br /><br>Sub-study 3)<br /><br>• Design requirements of the motorized arm support</p><br>