Assessment of the Effects of Sheffield Support Snood in MND Patients
Primary Purpose
Motor Neurone Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Head movements
Activities of daily living (drinking, washing hand and eating)
Sheffield Support Snood
sEMG
Sponsored by
About this trial
This is an interventional supportive care trial for Motor Neurone Disease
Eligibility Criteria
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
Sites / Locations
- Royal Hallamshire Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Snood
Arm Description
All recruited participants will try out the snood
Outcomes
Primary Outcome Measures
angular velocity and acceleration measured by the inertial sensors
electrical activity produced by the muscle measured by the EMG system
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02464852
First Posted
April 23, 2015
Last Updated
October 13, 2016
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02464852
Brief Title
Assessment of the Effects of Sheffield Support Snood in MND Patients
Official Title
Assessment of the Effects of Sheffield Support Snood in MND Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Neurone Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Snood
Arm Type
Other
Arm Description
All recruited participants will try out the snood
Intervention Type
Behavioral
Intervention Name(s)
Head movements
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Activities of daily living (drinking, washing hand and eating)
Intervention Description
Patients will be asked to perform a series of activities of daily living (drinking, eating and washing hands).
Intervention Type
Device
Intervention Name(s)
Sheffield Support Snood
Intervention Type
Device
Intervention Name(s)
sEMG
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Effects of Sheffield Support Snood in MND Patients
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