NCT04269291

Brief Summary

The assessment of muscular function, quality and ability is of high importance in a diverse range of clinical disciplines from anaesthetics to physiotherapy. This study will look at the range of measurement techniques currently in use and development and considers their effectiveness and objectivity. It will also investigate whether an objective measurement technique can be found or developed that can be used both in the clinical environment and the community setting. This will focus on upper limb function and ability; ability is used here instead of strength since ability better describes functions needed for daily living rather than the maximum output a muscle is capable of.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 18, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

January 15, 2020

Last Update Submit

March 11, 2022

Conditions

Keywords

electrical impedanceskeletal muscle

Outcome Measures

Primary Outcomes (1)

  • Observation of healthy volunteer measurement of Electrical Impedance Myography in arm muscles.

    Primary Objective To measure EIM in sketetal arm muscle. Measurements to be made when the muscles are passive and when they are contracted. EIM measurements are reactance and resistance which are both measured in Ohms. At least 20 eligible and consented volunteers to be recruited and measured. To be measured at the one healthy volunteer visit. No other visits are part of the study.

    One visit per volunteer. Data to be accumulated over approximately 1 year

Secondary Outcomes (2)

  • Age of participants

    through study completion, an average of 1 year

  • Fitness health measure of participants

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers

You may qualify if:

  • be volunteers
  • be over the age of 18
  • no pre-existing neuromuscular disease
  • not have an implanted cardiac device
  • be well at the time of measurement
  • be able to give informed consent

You may not qualify if:

  • Any existing neuromuscular disorder (eg multiple sclerosis, ALS, MND, CP)
  • Any existing cardiac disease (including having a pacemaker or ICD)
  • Active arthritis
  • Be pregnant
  • Any other implanted electrical device
  • Not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiff and Vale University Health Board.

Cardiff, CF14 4XW, United Kingdom

Location

Study Officials

  • Stephanie Wentworth

    stephanie.wentworth@wales.nhs.uk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

January 15, 2020

First Posted

February 13, 2020

Study Start

June 18, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

March 14, 2022

Record last verified: 2022-03

Locations