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Evaluation of a Textile Scapula Orthosis (ScapOrthosis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154098
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Muscular Dystrophies Scapular Dyskinesis Muscular Dystrophy, Facioscapulohumeral Muscle Weakness Muscular Weakness Muscular Dystrophy Device: Scapula orthosis assistance Procedure: Manual scapula assistance Other: No assistance Other: Functional Test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All patients perform the experiment in all conditions. The without orthosis, with orthosis and manual assistance conditions will be presented in randomized order, followed by the functional task.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of a Method to Support Unstable Shoulders by Means of a Textile Scapula Orthosis
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021


Arm Intervention/treatment
Experimental: NO-OA-MA-FT
Participants elevate their arm without assistance (NO) - with orthosis assistance (OA) - with manual assistance (MA) in the given order, followed by the functional task (FT)
Device: Scapula orthosis assistance
Participants are elevating their arm while their scapula is assisted by the scapula orthosis
Other Name: OA

Procedure: Manual scapula assistance
Participants are elevating their arm while their scapula is assisted by a trained personnel
Other Name: MA

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
Other Name: FT

Experimental: NO-MA-OA-FT
Participants elevate their arm without assistance (NO) - with orthosis assistance (OA) - with manual assistance (MA) in the given order, followed by the functional task (FT)
Device: Scapula orthosis assistance
Participants are elevating their arm while their scapula is assisted by the scapula orthosis
Other Name: OA

Procedure: Manual scapula assistance
Participants are elevating their arm while their scapula is assisted by a trained personnel
Other Name: MA

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
Other Name: FT

Experimental: OA-NO-MA-FT
Participants elevate their arm without assistance (NO) - with orthosis assistance (OA) - with manual assistance (MA) in the given order, followed by the functional task (FT)
Device: Scapula orthosis assistance
Participants are elevating their arm while their scapula is assisted by the scapula orthosis
Other Name: OA

Procedure: Manual scapula assistance
Participants are elevating their arm while their scapula is assisted by a trained personnel
Other Name: MA

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
Other Name: FT

Experimental: OA-MA-NO-FT
Participants elevate their arm without assistance (NO) - with orthosis assistance (OA) - with manual assistance (MA) in the given order, followed by the functional task (FT)
Device: Scapula orthosis assistance
Participants are elevating their arm while their scapula is assisted by the scapula orthosis
Other Name: OA

Procedure: Manual scapula assistance
Participants are elevating their arm while their scapula is assisted by a trained personnel
Other Name: MA

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
Other Name: FT

Experimental: MA-NO-OA-FT
Participants elevate their arm without assistance (NO) - with orthosis assistance (OA) - with manual assistance (MA) in the given order, followed by the functional task (FT)
Device: Scapula orthosis assistance
Participants are elevating their arm while their scapula is assisted by the scapula orthosis
Other Name: OA

Procedure: Manual scapula assistance
Participants are elevating their arm while their scapula is assisted by a trained personnel
Other Name: MA

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
Other Name: FT

Experimental: MA-OA-NO-FT
Participants elevate their arm without assistance (NO) - with orthosis assistance (OA) - with manual assistance (MA) in the given order, followed by the functional task (FT)
Device: Scapula orthosis assistance
Participants are elevating their arm while their scapula is assisted by the scapula orthosis
Other Name: OA

Procedure: Manual scapula assistance
Participants are elevating their arm while their scapula is assisted by a trained personnel
Other Name: MA

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
Other Name: FT




Primary Outcome Measures :
  1. Range of motion of arm elevation [ Time Frame: Up to 2 hours per participant ]
    The maximum angle of arm elevation in the 80 or 30 degree plane the participant can reach under the different study conditions

  2. Improvement of range of motion of arm elevation [ Time Frame: Up to 2 hours per participant ]
    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

  3. Range of motion of arm elevation for different force levels in the orthosis assistance condition [ Time Frame: Up to 2 hours per participant ]
    Relative or absolute improvement in range of motion or range of motion of arm elevation for different force levels in the orthosis assistance condition

  4. Motor control during functional task [ Time Frame: Up to 2 hours per participant ]
    Assessment of kinematic variables such as movement smoothness during the functional task


Secondary Outcome Measures :
  1. Beneficiary or Responsiveness level [ Time Frame: Up to 2 hours per participant ]
    Identification of beneficiary/responsiveness threshold in the correlation between range of motion of arm elevation with orthosis assistance and without assistance

  2. Threshold for Beneficiary or Responsiveness level [ Time Frame: Up to 2 hours per participant ]
    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)

  3. Perceived effort [ Time Frame: Up to 2 hours per participant ]
    Perceived effort (Borg Scale) of arm elevation for the different study conditions

  4. Motor control during arm elevation [ Time Frame: Up to 2 hours per participant ]
    Assessment of kinematic variables such as movement smoothness for the different study conditions

  5. Comfort [ Time Frame: Up to 2 hours per participant ]
    Assessment and comparison of discomfort during the different conditions (Modified short version of the Nordic Questionnaire)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Diagnosed scapula alata (winging scapula)
  • Limited range of motion of at least one of the upper extremities.
  • Ability to elevate the arm at least 110° passively
  • Able to sit in a chair without additional support and without leaning on the back rest.

Exclusion Criteria

  • Frozen shoulder
  • Osteoporosis or arthrosis of the shoulder joint
  • Shoulder subluxation
  • Excessive spasticity of the affected arm
  • Skin ulcerations on the paretic arm or torso
  • Known risk for impingement
  • Orthopaedic, rheumatological or other disease restricting movements of the paretic arm
  • Pain or stiffness in the shoulder joint limiting their movement
  • Cardiopulmonary disease
  • Psychiatric disorders or severe cognitive impairments that limit their ability to understand the study instructions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154098


Contacts
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Contact: Anna-Maria Georgarakis, M.Sc. +41788559635 marie.georgarakis@hest.ethz.ch
Contact: Michele Xiloannis, Dr.Sc. michele.xiloyannis@hest.ethz.ch

Locations
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Germany
Kliniken Schmieder Konstanz Recruiting
Konstanz, Basen-Wuerttemberg, Germany, 78464
Contact: Anna-Maria Georgarakis, M.Sc.    +41788559635    marie.georgarakis@hest.ethz.ch   
Contact: Michele Xiloyannis, Dr.Sc.       michele.xiloyannis@hest.ethz.ch   
Switzerland
ETH Zurich Recruiting
Zurich, Switzerland, 8006
Contact: Anna-Maria Georgarakis, M.Sc.    +41788559635    marie.georgarakis@hest.ethz.ch   
Contact: Michele Xiloyannis, Dr. Sc.       michele.xiloyannis@hest.ethz.ch   
Sponsors and Collaborators
Swiss Federal Institute of Technology
Investigators
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Principal Investigator: Robert Riener, Prof. ETH Zurich
Publications:

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Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT04154098    
Other Study ID Numbers: ScapulaOrthosis_v1
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swiss Federal Institute of Technology:
Scapula alata
Scapular winging
Scapula orthosis
Range of Motion
Movement control
Manual Scapula Assistance
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscle Weakness
Muscular Dystrophy, Facioscapulohumeral
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Neuromuscular Manifestations
Neurologic Manifestations
Pathologic Processes