Ignite Creation Date:
2024-05-06 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03617276
Status:
COMPLETED
Last Update Posted:
2018-08-06
First Post:
2018-08-01
Brief Title:
Reliability of Functional Outcome Measures in Neurofibromatosis 2
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
A Study Investigating the Inter- and Intra- Rater Reliability of Functional Outcome Measures in Neurofibromatosis 2
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neurofibromatosis 2 NF2 is a rare inherited condition Those with NF2 usually present with tumours schwannomas in their inner ear or vestibular organ with common symptoms including problems with hearing balance dizziness and vision This study aims to evaluate the reliability stability of a range of functional standardised outcome measures in adults with NF2
Detailed Description:
Neurofibromatosis 2 NF2 is an inherited condition that occurs in 1 in 33000 births affecting hearing balance dizziness and vision primarily related to tumours schwannomas in the inner ear or other tumours which develop within the central nervous system Neuropathy may also be an issue for people with NF2
The complications of NF2 can lead to varied difficulties with activities of daily living and may impair quality of life More recently new pharmacological treatments for NF2 are being trialed which may have the potential to dramatically influence quality of life for people with NF2 Currently evaluation of treatment effect in NF2 is based on a clinicians neurological assessment and imaging However imaging results do not always correlate with clinical and reported functional changes of the individual Therefore evaluating the effect of interventions or treatment should include the evaluation of a persons function using standardised outcome measures The findings from this study will improve the care of people with NF2 by ensuring that we are able to measure functional changes in a person with NF2 with greater confidence meaning that we can start continue or cease treatments based on the holistic picture of an individual
The world confederation of physiotherapists WCPT stipulates that standardised outcome measures SOM are used to provide a quantitative measure of capability and to evaluate the impact of treatment on function There are a wide range of SOMs that evaluate function so a SOM is chosen by the clinician based on the patients presenting functional difficulty and the scientific credibility of the SOM Scientific credibility robustness is based on scientific properties of the SOM ie how stable the SOM is reliability and whether it assesses what it is intending to assess validity It is important to evaluate each SOM within the target population as variability within that condition strongly influences the SOMs reliability and validity de Vel 2011
At present functional SOMs have limited scientific and subsequent clinical credibility when used in people with NF2 because their scientific properties have not yet been evaluated within this patient group which means that if they are used clinically or within research there is an inherent element of doubt when interpreting the SOMs results The objective of this research team is to create a core set of functional SOMs which have undergone rigorous scientific evaluation so that they can be used in the future for clinical practice and for research purposes in adults with NF2
This study primarily aims to evaluate three commonly used SOMs for reliability in adults with NF2 over 16 years of age The measures chosen for evaluation are the nine hole peg test the four square step test and the modified clinical test of sensory integration and balance mCTSIB Interrater reliability the test result remains the same when reviewed by different people and intrarater reliability the test result remains stable when reviewed twice by the same tester will be evaluated From this data we will be able to calculate the standard error of measurement an additional important scientific characteristics of SOM evaluation A secondary objective is to correlate SOM objective markers with a subjective disease specific quality of life measure NFTI-QOL and self-reported falls rate and near misses We will also collect data on dynamic visual acuity in this patient group
The complications of NF2 can lead to varied difficulties with activities of daily living and may impair quality of life More recently new pharmacological treatments for NF2 are being trialed which may have the potential to dramatically influence quality of life for people with NF2 Currently evaluation of treatment effect in NF2 is based on a clinicians neurological assessment and imaging However imaging results do not always correlate with clinical and reported functional changes of the individual Therefore evaluating the effect of interventions or treatment should include the evaluation of a persons function using standardised outcome measures The findings from this study will improve the care of people with NF2 by ensuring that we are able to measure functional changes in a person with NF2 with greater confidence meaning that we can start continue or cease treatments based on the holistic picture of an individual
The world confederation of physiotherapists WCPT stipulates that standardised outcome measures SOM are used to provide a quantitative measure of capability and to evaluate the impact of treatment on function There are a wide range of SOMs that evaluate function so a SOM is chosen by the clinician based on the patients presenting functional difficulty and the scientific credibility of the SOM Scientific credibility robustness is based on scientific properties of the SOM ie how stable the SOM is reliability and whether it assesses what it is intending to assess validity It is important to evaluate each SOM within the target population as variability within that condition strongly influences the SOMs reliability and validity de Vel 2011
At present functional SOMs have limited scientific and subsequent clinical credibility when used in people with NF2 because their scientific properties have not yet been evaluated within this patient group which means that if they are used clinically or within research there is an inherent element of doubt when interpreting the SOMs results The objective of this research team is to create a core set of functional SOMs which have undergone rigorous scientific evaluation so that they can be used in the future for clinical practice and for research purposes in adults with NF2
This study primarily aims to evaluate three commonly used SOMs for reliability in adults with NF2 over 16 years of age The measures chosen for evaluation are the nine hole peg test the four square step test and the modified clinical test of sensory integration and balance mCTSIB Interrater reliability the test result remains the same when reviewed by different people and intrarater reliability the test result remains stable when reviewed twice by the same tester will be evaluated From this data we will be able to calculate the standard error of measurement an additional important scientific characteristics of SOM evaluation A secondary objective is to correlate SOM objective markers with a subjective disease specific quality of life measure NFTI-QOL and self-reported falls rate and near misses We will also collect data on dynamic visual acuity in this patient group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None