NCT02464852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 14, 2016

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

April 23, 2015

Last Update Submit

October 13, 2016

Conditions

Outcome Measures

Primary Outcomes (3)

  • angular velocity and acceleration measured by the inertial sensors

    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

    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.

    after the subject has performed the head movements (Extension, flexion, axial rotation and lateral bending). Answer the questionnaire will take approximately 10 minutes

Study Arms (1)

Snood

OTHER

All recruited participants will try out the snood

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

Interventions

Head movementsBEHAVIORAL

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.

Snood

Patients will be asked to perform a series of activities of daily living (drinking, eating and washing hands).

Snood
sEMGDEVICE
Snood

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical status consistent with MND
  • Capability to understand instructions
  • Capability to perform testing procedures
  • Ability to give informed consent

You may not qualify if:

  • Presence of any inflammatory or other disease involving joint or muscle pathology that might affects testing results
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Head MovementsActivities of Daily LivingDrinkingHand DisinfectionEating

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological PhenomenaHand HygieneHygienePublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

June 8, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 14, 2016

Record last verified: 2015-06

Locations