CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Scapula orthosis assistance +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04154098
NCT04154098N/ACompleted

Evaluation of a Method to Support Unstable Shoulders by Means of a Textile Scapula Orthosis

Swiss Federal Institute of Technology·interventional·Posted Nov 6, 2019·Updated Dec 16, 2020

In Brief

A clinical study evaluating Scapula orthosis assistance, Manual scapula assistance, and 2 other interventions for Muscular Dystrophies and 5 related conditions. Completed, enrolled 8 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Switzerland
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 6, 2019
Enrollment StartNov 1, 2019
Primary CompletionJul 13, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.7 years ago

Interventions

Scapula orthosis assistancedevice

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

Manual scapula assistanceprocedure

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

No assistanceother

Participants are elevating their arm without being assisted

Functional Testother

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