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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53514

Enrollment

Registered

2023-11-10

Start date

2023-11-30

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

DMD Duchenne muscular dystrophy

Interventions

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 su

Eligibility

Age

16 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)