- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02464852
Assessment of the Effects of Sheffield Support Snood in MND Patients
October 13, 2016 updated by: Sheffield Teaching Hospitals NHS Foundation Trust
The aim of this study is to evaluate the effects on MND patients of a new collar specifically designed for people affected by neck weakness: the Sheffield Support Snood.
Study Overview
Status
Completed
Conditions
Detailed Description
Motor Neurone Disease (MND) is neurodegenerative disorder that leads to progressive weakness of limb, bulbar and respiratory muscles.
The most common form of the disease is the Amyotrophic Lateral Sclerosis (ALS).
Severe weakness of the neck extensor muscles is common in patients with ALS.
Those patients are advised to wear a cervical collar, to improve their neck posture and social interaction.
However the main limit of commercially available collars is that they are designed to immobilize the neck, which makes them uncomfortable and strenuous to wear for long time.
The aim of this study is to evaluate the effects on MND patients of a new collar specifically designed for people affected by neck weakness: the Sheffield Support Snood.
The assessment will be performed through the use of inertial sensors since they allow the measurement to be performed in real life settings (clinics/home) with reduced discomfort to the patient.
Subjects will be asked to perform a series of active head movements (flexion, extension, axial rotation, lateral bending) with and without the collar and the range of movement measured in the two cases will be used to assess the support offered by the collar.
Since in MND patients difficulty in perform active head movements is due to a severe weakness of the extensor muscles, with or without involvement of the neck flexors, this study will also investigate the activation of these muscles while the subject is performing the active head movements.
A wireless surface electromyographic system (sEMG) will be used to this purpose.
Patients able to perform a series of activities of daily living (ADL, ie: drinking, eating, washing hands) will be asked to perform the tasks both with and without the collar.
The support perceived by the subjects while they are performing the ADL will be evaluated through a questionnaire specifically developed for this study.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Yorkshire
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Sheffield, South Yorkshire, United Kingdom, S10 2JF
- Royal Hallamshire Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical status consistent with MND
- Capability to understand instructions
- Capability to perform testing procedures
- Ability to give informed consent
Exclusion Criteria:
- Presence of any inflammatory or other disease involving joint or muscle pathology that might affects testing results
- Unable to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Snood
All recruited participants will try out the snood
|
Participants will be asked to perform a series of movements of exploration of their maximum neck range of motion, including: flexion, extension, right and left lateral flexion, right and left axial rotation.
Patients will be asked to perform a series of activities of daily living (drinking, eating and washing hands).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
angular velocity and acceleration measured by the inertial sensors
Time Frame: while the subject is performing the head movements (Extension, flexion, axial rotation and lateral bending). Data collection will take approximately 30 minutes
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while the subject is performing the head movements (Extension, flexion, axial rotation and lateral bending). Data collection will take approximately 30 minutes
|
electrical activity produced by the muscle measured by the EMG system
Time Frame: while the subject is performing the head movements (Extension, flexion, axial rotation and lateral bending). Data collection will take approximately 30 minutes
|
while the subject is performing the head movements (Extension, flexion, axial rotation and lateral bending). Data collection will take approximately 30 minutes
|
Description of the support perceived. It will be evaluated through a questionnaire which will include a series of sentences that describe the support offered by the collar. The subjects will be asked to state how much they agree with those sentences.
Time Frame: after the subject has performed the head movements (Extension, flexion, axial rotation and lateral bending). Answer the questionnaire will take approximately 10 minutes
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after the subject has performed the head movements (Extension, flexion, axial rotation and lateral bending). Answer the questionnaire will take approximately 10 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
April 23, 2015
First Submitted That Met QC Criteria
June 3, 2015
First Posted (Estimate)
June 8, 2015
Study Record Updates
Last Update Posted (Estimate)
October 14, 2016
Last Update Submitted That Met QC Criteria
October 13, 2016
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STH18733
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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