Assessment of the Effects of Sheffield Support Snood in MND Patients

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NHS Foundation Trust

Status

Completed

Conditions

Motor Neurone Disease

Treatments

Behavioral: Activities of daily living (drinking, washing hand and eating)
Device: sEMG
Device: Sheffield Support Snood
Behavioral: Head movements

Study type

Interventional

Funder types

Other

Identifiers

NCT02464852
STH18733

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Snood
Other group
Description:
All recruited participants will try out the snood
Treatment:
Behavioral: Head movements
Device: Sheffield Support Snood
Device: sEMG
Behavioral: Activities of daily living (drinking, washing hand and eating)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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