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Evaluation of a Textile Scapula Orthosis (ScapOrthosis)

Primary Purpose

Muscular Dystrophies, Scapular Dyskinesis, Muscular Dystrophy, Facioscapulohumeral

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Scapula orthosis assistance
Manual scapula assistance
No assistance
Functional Test
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscular Dystrophies focused on measuring Scapula alata, Scapular winging, Scapula orthosis, Range of Motion, Movement control, Manual Scapula Assistance

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kliniken Schmieder Konstanz
  • ETH Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

NO-OA-MA-FT

NO-MA-OA-FT

OA-NO-MA-FT

OA-MA-NO-FT

MA-NO-OA-FT

MA-OA-NO-FT

Arm Description

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)

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)

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)

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)

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)

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)

Outcomes

Primary Outcome Measures

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
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
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
Motor control during functional task
Assessment of kinematic variables such as movement smoothness during the functional task

Secondary Outcome Measures

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
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)
Perceived effort
Perceived effort (Borg Scale) of arm elevation for the different study conditions
Motor control during arm elevation
Assessment of kinematic variables such as movement smoothness for the different study conditions
Comfort
Assessment and comparison of discomfort during the different conditions (Modified short version of the Nordic Questionnaire)

Full Information

First Posted
October 23, 2019
Last Updated
December 14, 2020
Sponsor
Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04154098
Brief Title
Evaluation of a Textile Scapula Orthosis
Acronym
ScapOrthosis
Official Title
Evaluation of a Method to Support Unstable Shoulders by Means of a Textile Scapula Orthosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
July 13, 2020 (Actual)
Study Completion Date
July 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In this study, participants suffering from muscular weakness in the upper extremities, particularly the shoulder joint, will be recruited. A clear indicator for muscular weakness in the shoulder joint is a scapula alata (winging scapula). Hence, participants recruited for this study should present with a scapula alata and a limited RoM of at least one of their upper extremities. This study is designed as a cross-over trial. Each participant will take part in an experimental session that will last approximately 2 hours. At the beginning of the experiment, the participant will be informed about the measurement and sign the informed consent sheet. Additional demographic data and level of ability will be collected in a questionnaire. Before the measurements, participants will be fitted a textile scapula orthosis. The orthosis will be instrumented to quantify the amount of support the orthosis provides to the user. Therefore, an array of force sensors is mounted between the orthosis and the skin to measure the qualitative force distribution and its rate of change. To measure the absolute force applied to the plate, a load cell will be mounted on the orthosis fastening mechanism. All force data will be collected synchronously through a Micro-Controller board. The participants will be equipped with reflective adhesive markers to define the reference points for the range of motion measurements, which will be done with a goniometer and photographic opto-electronic motion tracking. Nine blocks of measurements will be conducted, lasting 5 minutes each. The remaining time in the study accounts for rest periods, the mounting and demounting of the orthosis, instructions and questionnaires. The first eight blocks will present the following treatment conditions in randomized order: No support (NO): the scapula is not assisted during arm elevation. Manual scapular assistance (SA): a trained person assists the scapula during arm elevation manually. Orthosis support (OS): the scapula is assisted by the textile orthosis set to meaningfully different force levels. Motor control task (MT): The participant reaches for a target placed at the maximum elevation height in the NO condition, once without and once with the orthosis. While one block each is performed in the NO, SA and MT conditions, six blocks are performed in the OS condition with the orthosis set to meaningfully different force levels. In each measurement set, participants will elevate their arms in one of two planes of horizontal rotation: 30° (R30) as measured from the coronal body plane. 80° (R80) as measured from the coronal body plane. During arm elevation, the arm is fully extended, i.e. the elbow and wrist are fully stretched. In this position, the center of mass has the largest lever arm and therefore the maximum torque due to gravity occurs in the shoulder. One measurement set will be done in each elevation plane. During the OS condition, the orthosis will be opened between measurement sets to allow for comfort and unhindered breathing and to guarantee independence of measurement data. After the experiment, the perceived exertion and orthosis comfort will be assessed using the Borg Scale and the Nordic Questionnaire. Before the study, several study parameters will be determined in pilot studies with variable duration, not exceeding 2 hours. The participants in the pilot studies and the final study might be identical. During the pilot tests, participants will wear an orthosis similar to the one used in the study. Hence, effort and strain for participants will be equal or less to the final study. The pilot tests include Definition of optimal pressure and protocol to consistently find this pressure. Definition of optimal orthosis configuration. Definition of repeatability when orthosis is unmounted and mounted again. Definition of meaningful difference between pressure levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophies, Scapular Dyskinesis, Muscular Dystrophy, Facioscapulohumeral, Muscle Weakness, Muscular Weakness, Muscular Dystrophy
Keywords
Scapula alata, Scapular winging, Scapula orthosis, Range of Motion, Movement control, Manual Scapula Assistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NO-OA-MA-FT
Arm Type
Experimental
Arm Description
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)
Arm Title
NO-MA-OA-FT
Arm Type
Experimental
Arm Description
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)
Arm Title
OA-NO-MA-FT
Arm Type
Experimental
Arm Description
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)
Arm Title
OA-MA-NO-FT
Arm Type
Experimental
Arm Description
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)
Arm Title
MA-NO-OA-FT
Arm Type
Experimental
Arm Description
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)
Arm Title
MA-OA-NO-FT
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Scapula orthosis assistance
Other Intervention Name(s)
OA
Intervention Description
Participants are elevating their arm while their scapula is assisted by the scapula orthosis
Intervention Type
Procedure
Intervention Name(s)
Manual scapula assistance
Other Intervention Name(s)
MA
Intervention Description
Participants are elevating their arm while their scapula is assisted by a trained personnel
Intervention Type
Other
Intervention Name(s)
No assistance
Intervention Description
Participants are elevating their arm without being assisted
Intervention Type
Other
Intervention Name(s)
Functional Test
Other Intervention Name(s)
FT
Intervention Description
Participants perform a functional test once without (NO) and once with (OA) the orthosis
Primary Outcome Measure Information:
Title
Range of motion of arm elevation
Description
The maximum angle of arm elevation in the 80 or 30 degree plane the participant can reach under the different study conditions
Time Frame
Up to 2 hours per participant
Title
Improvement of range of motion of arm elevation
Description
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
Time Frame
Up to 2 hours per participant
Title
Range of motion of arm elevation for different force levels in the orthosis assistance condition
Description
Relative or absolute improvement in range of motion or range of motion of arm elevation for different force levels in the orthosis assistance condition
Time Frame
Up to 2 hours per participant
Title
Motor control during functional task
Description
Assessment of kinematic variables such as movement smoothness during the functional task
Time Frame
Up to 2 hours per participant
Secondary Outcome Measure Information:
Title
Beneficiary or Responsiveness level
Description
Identification of beneficiary/responsiveness threshold in the correlation between range of motion of arm elevation with orthosis assistance and without assistance
Time Frame
Up to 2 hours per participant
Title
Threshold for Beneficiary or Responsiveness level
Description
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)
Time Frame
Up to 2 hours per participant
Title
Perceived effort
Description
Perceived effort (Borg Scale) of arm elevation for the different study conditions
Time Frame
Up to 2 hours per participant
Title
Motor control during arm elevation
Description
Assessment of kinematic variables such as movement smoothness for the different study conditions
Time Frame
Up to 2 hours per participant
Title
Comfort
Description
Assessment and comparison of discomfort during the different conditions (Modified short version of the Nordic Questionnaire)
Time Frame
Up to 2 hours per participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Riener, Prof.
Organizational Affiliation
ETH Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kliniken Schmieder Konstanz
City
Konstanz
State/Province
Basen-Wuerttemberg
ZIP/Postal Code
78464
Country
Germany
Facility Name
ETH Zurich
City
Zurich
ZIP/Postal Code
8006
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17222853
Citation
Veeger HE, van der Helm FC. Shoulder function: the perfect compromise between mobility and stability. J Biomech. 2007;40(10):2119-29. doi: 10.1016/j.jbiomech.2006.10.016. Epub 2007 Jan 12.
Results Reference
background
PubMed Identifier
8348140
Citation
Paine RM, Voight M. The role of the scapula. J Orthop Sports Phys Ther. 1993 Jul;18(1):386-91. doi: 10.2519/jospt.1993.18.1.386.
Results Reference
background
PubMed Identifier
19194022
Citation
Ludewig PM, Reynolds JF. The association of scapular kinematics and glenohumeral joint pathologies. J Orthop Sports Phys Ther. 2009 Feb;39(2):90-104. doi: 10.2519/jospt.2009.2808.
Results Reference
background
PubMed Identifier
20091543
Citation
Orrell RW, Copeland S, Rose MR. Scapular fixation in muscular dystrophy. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD003278. doi: 10.1002/14651858.CD003278.pub2.
Results Reference
background
PubMed Identifier
25910775
Citation
Vastamaki M, Pikkarainen V, Vastamaki H, Ristolainen L. Scapular Bracing is Effective in Some Patients but Symptoms Persist in Many Despite Bracing. Clin Orthop Relat Res. 2015 Aug;473(8):2650-7. doi: 10.1007/s11999-015-4310-1. Epub 2015 Apr 25.
Results Reference
background
PubMed Identifier
8907215
Citation
Barnett ND, Mander M, Peacock JC, Bushby K, Gardner-Medwin D, Johnson GR. Winging of the scapula: the underlying biomechanics and an orthotic solution. Proc Inst Mech Eng H. 1995;209(4):215-23. doi: 10.1243/PIME_PROC_1995_209_348_02.
Results Reference
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PubMed Identifier
15370589
Citation
Jepsen J, Laursen L, Larsen A, Hagert CG. Manual strength testing in 14 upper limb muscles: a study of inter-rater reliability. Acta Orthop Scand. 2004 Aug;75(4):442-8. doi: 10.1080/00016470410001222-1.
Results Reference
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PubMed Identifier
17558881
Citation
Nadeau S, Kovacs S, Gravel D, Piotte F, Moffet H, Gagnon D, Hebert LJ. Active movement measurements of the shoulder girdle in healthy subjects with goniometer and tape measure techniques: a study on reliability and validity. Physiother Theory Pract. 2007 May-Jun;23(3):179-87. doi: 10.1080/09593980701209246.
Results Reference
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PubMed Identifier
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Citation
Georgarakis AM, Xiloyannis M, Dettmers C, Joebges M, Wolf P, Riener R. Reaching higher: External scapula assistance can improve upper limb function in humans with irreversible scapula alata. J Neuroeng Rehabil. 2021 Sep 3;18(1):131. doi: 10.1186/s12984-021-00926-z.
Results Reference
derived

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Evaluation of a Textile Scapula Orthosis

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