Evaluation of a Textile Scapula Orthosis

Muscle Weakness Clinical Trial

— ScapOrthosis  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04154098
• Other study ID #: ScapulaOrthosis_v1
• Status: Completed
• Phase: N/A
• 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
• 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 13, 2020
• Est. primary completion date: July 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

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)

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. — View 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. — View 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. Review. — View Citation

Nadeau S, Kovacs S, Gravel D, Piotte F, Moffet H, Gagnon D, Hébert 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. — View Citation

Orrell RW, Copeland S, Rose MR. Scapular fixation in muscular dystrophy. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003278. doi: 10.1002/14651858.CD003278.pub2. Review. — View Citation

Paine RM, Voight M. The role of the scapula. J Orthop Sports Phys Ther. 1993 Jul;18(1):386-91. Review. — View Citation

Vastamäki M, Pikkarainen V, Vastamäki 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. — View Citation

Veeger HE, van der Helm FC. Shoulder function: the perfect compromise between mobility and stability. J Biomech. 2007;40(10):2119-29. Epub 2007 Jan 12. Review. — View Citation

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