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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04154098
Other study ID # ScapulaOrthosis_v1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date July 13, 2020

Study information

Verified date December 2020
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Kliniken Schmieder Konstanz Konstanz Basen-Wuerttemberg
Switzerland ETH Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
Swiss Federal Institute of Technology

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Primary Range of motion of arm elevation The maximum angle of arm elevation in the 80 or 30 degree plane the participant can reach under the different study conditions Up to 2 hours per participant
Primary Improvement of range of motion of arm elevation The relative or absolute improvement of arm elevation in the orthosis assistance condition when compared to the without assistance condition and/or the manual assistance condition Up to 2 hours per participant
Primary Range of motion of arm elevation for different force levels in the orthosis assistance condition Relative or absolute improvement in range of motion or range of motion of arm elevation for different force levels in the orthosis assistance condition Up to 2 hours per participant
Primary Motor control during functional task Assessment of kinematic variables such as movement smoothness during the functional task Up to 2 hours per participant
Secondary Beneficiary or Responsiveness level Identification of beneficiary/responsiveness threshold in the correlation between range of motion of arm elevation with orthosis assistance and without assistance Up to 2 hours per participant
Secondary Threshold for Beneficiary or Responsiveness level Correlation between beneficiary/responsiveness level and level of disability as assessed by the Manual Muscle Test (MMT, Jepsen 2004) and/or the Range of Motion Test (Nadeau 2007) Up to 2 hours per participant
Secondary Perceived effort Perceived effort (Borg Scale) of arm elevation for the different study conditions Up to 2 hours per participant
Secondary Motor control during arm elevation Assessment of kinematic variables such as movement smoothness for the different study conditions Up to 2 hours per participant
Secondary Comfort Assessment and comparison of discomfort during the different conditions (Modified short version of the Nordic Questionnaire) Up to 2 hours per participant
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