Evaluation of a Textile Scapula Orthosis

NCT04154098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-12-16

No results posted yet for this study

Summary

Shoulder instability due to muscle weakness is a common problem in disorders of the upper extremities. During arm motion, the scapula acts as a dynamic base for the humeral head. To safely move the shoulder with an exoskeleton for the upper extremities a textile orthosis was developed that stabilizes the scapula against the thorax. The support level of the orthosis is continuously manually adjustable. To test the feasibility of our design and to improve the functionality of the textile orthosis, it needs to be investigated how the orthosis acts on people affected by shoulder instability. The investigators seek to explore how people with shoulder instability respond to the orthosis, and how they may benefit from the orthosis function. Therefore, the range of motion of arm elevation will be compared in different conditions: (i) without any support, (ii) with the support of a trained therapist, and (iii) when the device is engaged at the individual's optimal support level. Additionally, pilot tests will be performed to fix different parameters in our study protocol, such as the the optimal orthosis stiffness level and the ideal number of movement repetitions.

Conditions

  • Muscular Dystrophies
  • Scapular Dyskinesis
  • Muscular Dystrophy, Facioscapulohumeral
  • Muscle Weakness
  • Muscular Weakness
  • Muscular Dystrophy

Interventions

DEVICE

Scapula orthosis assistance

Participants are elevating their arm while their scapula is assisted by the scapula orthosis

PROCEDURE

Manual scapula assistance

Participants are elevating their arm while their scapula is assisted by a trained personnel

OTHER

No assistance

Participants are elevating their arm without being assisted

OTHER

Functional Test

Participants perform a functional test once without (NO) and once with (OA) the orthosis

Sponsors & Collaborators

  • Swiss Federal Institute of Technology

    lead OTHER

Principal Investigators

  • Robert Riener, Prof. · ETH Zurich

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-07-13
Completion
2020-07-13

Countries

  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04154098 on ClinicalTrials.gov