Evaluation of a Textile Scapula Orthosis

NCT04154098 | Completed

• 1 other identifier: ScapulaOrthosis_v1
• Study Type: interventional
• Target: 8
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Motor control during functional task

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

  Up to 2 hours per participant

Secondary Outcomes (5)

• Beneficiary or Responsiveness level

  Up to 2 hours per participant

• Threshold for Beneficiary or Responsiveness level

  Up to 2 hours per participant

• Perceived effort

  Up to 2 hours per participant

• Motor control during arm elevation

  Up to 2 hours per participant

• Comfort

  Up to 2 hours per participant

Study Arms (6)

NO-OA-MA-FT

EXPERIMENTAL

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; Procedure: Manual scapula assistance; Other: No assistance; Other: Functional Test

NO-MA-OA-FT

EXPERIMENTAL

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; Procedure: Manual scapula assistance; Other: No assistance; Other: Functional Test

OA-NO-MA-FT

EXPERIMENTAL

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; Procedure: Manual scapula assistance; Other: No assistance; Other: Functional Test

OA-MA-NO-FT

EXPERIMENTAL

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; Procedure: Manual scapula assistance; Other: No assistance; Other: Functional Test

MA-NO-OA-FT

EXPERIMENTAL

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; Procedure: Manual scapula assistance; Other: No assistance; Other: Functional Test

MA-OA-NO-FT

EXPERIMENTAL

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; Procedure: Manual scapula assistance; Other: No assistance; Other: Functional Test

Interventions

Scapula orthosis assistance DEVICE

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

Also known as: OA

MA-NO-OA-FT; MA-OA-NO-FT; NO-MA-OA-FT; NO-OA-MA-FT; OA-MA-NO-FT; OA-NO-MA-FT

Manual scapula assistance PROCEDURE

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

Also known as: MA

MA-NO-OA-FT; MA-OA-NO-FT; NO-MA-OA-FT; NO-OA-MA-FT; OA-MA-NO-FT; OA-NO-MA-FT

No assistance OTHER

Participants are elevating their arm without being assisted

MA-NO-OA-FT; MA-OA-NO-FT; NO-MA-OA-FT; NO-OA-MA-FT; OA-MA-NO-FT; OA-NO-MA-FT

Functional Test OTHER

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

Also known as: FT

MA-NO-OA-FT; MA-OA-NO-FT; NO-MA-OA-FT; NO-OA-MA-FT; OA-MA-NO-FT; OA-NO-MA-FT

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (2)

Kliniken Schmieder Konstanz

Konstanz, Basen-Wuerttemberg, 78464, Germany

Location

ETH Zurich

Zurich, 8006, Switzerland

Location

Related Publications (9)

• 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.

  PMID: 17222853 BACKGROUND

• 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.

  PMID: 8348140 BACKGROUND

• 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.

  PMID: 19194022 BACKGROUND

• 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.

  PMID: 20091543 BACKGROUND

• 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.

  PMID: 25910775 BACKGROUND

• 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.

  PMID: 8907215 BACKGROUND

• 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.

  PMID: 15370589 BACKGROUND

• 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.

  PMID: 17558881 BACKGROUND

• 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.

  PMID: 34479574 DERIVED

MeSH Terms

Conditions

Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral; Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Robert Riener, Prof.

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: November 6, 2019
• Study Start: November 1, 2019
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); DE (1)