Muscular DystrophiesScapOrthosisNCT04154098
Evaluation of a Textile Scapula Orthosis
A study testing Scapula orthosis assistance, Manual scapula assistance and No assistance in people with Muscular Dystrophies and Scapular Dyskinesis, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Muscular Dystrophies, Scapular Dyskinesis, Muscular Dystrophy, Facioscapulohumeral
- What is being tested?
- Scapula orthosis assistance, Manual scapula assistance and No assistance
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2019to 13 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of a Method to Support Unstable Shoulders by Means of a Textile Scapula Orthosis
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.
Read the 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.
- Conditions
- Muscular Dystrophies, Scapular Dyskinesis, Muscular Dystrophy, Facioscapulohumeral, Muscle Weakness, Muscular Weakness, Muscular Dystrophy
- Being tested
- Scapula orthosis assistance, Manual scapula assistance, No assistance, Functional Test
- Keywords
- Scapula alata, Scapular winging, Scapula orthosis, Range of Motion, Movement control, Manual Scapula Assistance
- Medical subject headings
- Muscular Dystrophies, Muscular Dystrophy, Facioscapulohumeral, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapula orthosis assistanceDevice
Also called OA
Participants are elevating their arm while their scapula is assisted by the scapula orthosis
Manual scapula assistanceProcedure or surgery
Also called MA
Participants are elevating their arm while their scapula is assisted by a trained personnel
No assistanceOther
Participants are elevating their arm without being assisted
Functional TestOther
Also called FT
Participants perform a functional test once without (NO) and once with (OA) the orthosis
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: Device: Scapula orthosis assistance; Procedure: Manual scapula assistance; Other: No assistance; Other: Functional Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Up to 2 hours per participant
Motor control during functional task
Assessment of kinematic variables such as movement smoothness during the functional task
Measured: Up to 2 hours per participant
Secondary outcomes (5)
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
Measured: Up to 2 hours per participant
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)
Measured: Up to 2 hours per participant
Perceived effort
Perceived effort (Borg Scale) of arm elevation for the different study conditions
Measured: Up to 2 hours per participant
Motor control during arm elevation
Assessment of kinematic variables such as movement smoothness for the different study conditions
Measured: Up to 2 hours per participant
Comfort
Assessment and comparison of discomfort during the different conditions (Modified short version of the Nordic Questionnaire)
Measured: Up to 2 hours per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Nov 2019
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Muscular DystrophiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Riener, Prof., Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154098
- Sponsor's protocol ID
- ScapulaOrthosis_v1
- Acronym
- ScapOrthosis
- Status last verified
- Dec 2020
- First submitted
- 23 Oct 2019
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17222853Paine 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.
PubMed 8348140Ludewig 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.
PubMed 19194022Orrell 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.
PubMed 20091543Vastamaki 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.
PubMed 25910775Barnett 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.
PubMed 8907215Jepsen 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.
PubMed 15370589Nadeau 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.
PubMed 17558881Georgarakis 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.
PubMed 34479574
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Method to Support Unstable Shoulders by Means of a Textile Scapula Orthosis
- ClinicalTrials.gov ID
- NCT04154098
- Acronym / sponsor ID
- ScapOrthosis / ScapulaOrthosis_v1
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| NO-OA-MA-FT | Experimental | Device: Scapula orthosis assistance, Procedure: Manual scapula assistance, Other: No assistance, Other: Functional TestParticipants elevate their arm without assistance (NO) - with orthosis assistance (OA) - with manual assistance (MA) in the given order, followed by the functional task (FT) |
| NO-MA-OA-FT | Experimental | Device: Scapula orthosis assistance, Procedure: Manual scapula assistance, Other: No assistance, Other: Functional TestParticipants elevate their arm without assistance (NO) - with orthosis assistance (OA) - with manual assistance (MA) in the given order, followed by the functional task (FT) |
| OA-NO-MA-FT | Experimental | Device: Scapula orthosis assistance, Procedure: Manual scapula assistance, Other: No assistance, Other: Functional TestParticipants elevate their arm without assistance (NO) - with orthosis assistance (OA) - with manual assistance (MA) in the given order, followed by the functional task (FT) |
| OA-MA-NO-FT | Experimental | Device: Scapula orthosis assistance, Procedure: Manual scapula assistance, Other: No assistance, Other: Functional TestParticipants elevate their arm without assistance (NO) - with orthosis assistance (OA) - with manual assistance (MA) in the given order, followed by the functional task (FT) |
| MA-NO-OA-FT | Experimental | Device: Scapula orthosis assistance, Procedure: Manual scapula assistance, Other: No assistance, Other: Functional TestParticipants elevate their arm without assistance (NO) - with orthosis assistance (OA) - with manual assistance (MA) in the given order, followed by the functional task (FT) |
| MA-OA-NO-FT | Experimental | Device: Scapula orthosis assistance, Procedure: Manual scapula assistance, Other: No assistance, Other: Functional TestParticipants elevate their arm without assistance (NO) - with orthosis assistance (OA) - with manual assistance (MA) in the given order, followed by the functional task (FT) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scapula orthosis assistanceAlso: OAParticipants are elevating their arm while their scapula is assisted by the scapula orthosis | Device | 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 assistanceAlso: MAParticipants are elevating their arm while their scapula is assisted by a trained personnel | Procedure or surgery | 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 assistanceParticipants are elevating their arm without being assisted | Other | 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 TestAlso: FTParticipants perform a functional test once without (NO) and once with (OA) the orthosis | Other | MA-NO-OA-FT, MA-OA-NO-FT, NO-MA-OA-FT, NO-OA-MA-FT, OA-MA-NO-FT, OA-NO-MA-FT |
Primary outcome
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
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
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
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
5 secondary outcomes
Beneficiary or Responsiveness level
Time frame: Up to 2 hours per participant
Threshold for Beneficiary or Responsiveness level
Time frame: Up to 2 hours per participant
Perceived effort
Time frame: Up to 2 hours per participant
Motor control during arm elevation
Time frame: Up to 2 hours per participant
Comfort
Time frame: Up to 2 hours per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Background: PubMed 17222853Veeger 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.
- Background: PubMed 8348140Paine 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.
- Background: PubMed 19194022Ludewig 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.
- Background: PubMed 20091543Orrell 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.
- Background: PubMed 25910775Vastamaki 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.
- Background: PubMed 8907215Barnett 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.
- Background: PubMed 15370589Jepsen 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.
- Background: PubMed 17558881Nadeau 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.
- Derived from this study: PubMed 34479574Georgarakis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Riener, Prof. principal investigator
ETH Zurich
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scapula orthosis assistance, Manual scapula assistance and No assistance in people with Muscular Dystrophies and Scapular Dyskinesis, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion of arm elevation (time frame: Up to 2 hours per participant). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154098, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.