Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05186870 |
| Other study ID # |
253954 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2019 |
| Est. completion date |
July 2025 |
Study information
| Verified date |
March 2023 |
| Source |
Guy's and St Thomas' NHS Foundation Trust |
| Contact |
Amelia Khan, MSc |
| Phone |
020 7188 5088 |
| Email |
amelia.khan[@]gstt.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To examine the test-retest reliability (how stable the results are when the same
participants, whose symptoms have remained stable, are assessed on 2 different occasions, 14
days apart) of the 10 meter walk test, the timed up and go test, the functional reach test
and the grip dynamometry test in adults with neurofibromatosis 1 (NF1).
Description:
Participants' will be recruited during their attendance to the National Centre for
Neurofibromatosis at Guy's hospital between August 2019 and March 2020 then following a
COVID-19 break, from March 2022 until October 2022. Guy's and St Thomas' Trust (GSTT) is a
National Centre for the diagnosis, management and support of approximately 1600 people with
neurofibromatosis 1. Currently patients' attend the clinic for their standard assessment
appointment every 6-12 months. They will receive a participant information sheet before their
appointment, and the treating clinician (specialist doctors and nurses) will confirm that the
individual meets the inclusion criteria and identify whether they wish to participate. At
each of these contact points as well as within the participant information sheet, the
potential participant will be advised that their decision to participate/ not to participate
within this study will have no impact on their clinical care. Each participant will be asked
to complete each outcome measure at both study visits.
Once written consent has been obtained each participant will be given a unique alphanumeric
identification code for use within the trial. Written consent to participate in the study
will be collected from the participant by the researcher (FD) on the day of their first
outcome measure appointment. The researcher will then start the outcome measurement testing
session. The participant will be expected to attend one additional appointments to their
standard bi-yearly/yearly appointment where data on the outcome measure will only be
collected, the additional appointment will be 14 days later. During each of these
appointments the participants will be asked to complete 4 outcome measures (Timed-up and go,
Timed 10m walk test, Functional reach test and Grip-A Dynamometry) 3 times (and a mean will
be taken) alongside completion of the neurofibromatosis 1 quality of life questionnaire
(INFQOL), and a basic neurological assessment (to establish a baseline of symptoms) During
their second appointment, in addition to above, the participant will also be asked if they
have noted any changes in their symptoms in the last 14 days. The testing procedure will take
approximately 60 minutes per participant in total outside of the individual's clinic
appointment time.
Outcome measures The 10m walk test will time how long it takes the participant to walk for a
distance of 10m (this will be on a marked walkway). The timed up and go test will time how
long it takes the participant to stand up from a chair, walk 3m, turn around and return to
sitting on the chair. For each of the above tests the participant will complete them
independently but can use a walking aid if they require to. The functional reach test will
require the participant to stand with there arm out in front of them and reach forward as far
as they can without moving their feet, the distance will be recorded with a tape measure
attached to the wall. The final test, the grip dynamometry with require the participant to
squeeze the Grip-A Dynamometer as hard as they can. They will complete these 3 times and a
mean score will be taken.
Data Analysis and sample size Data will be collected and analyzed using Pearson and
intra-class correlation models. These models are recommended when testing for reliability as
repeated measurements cannot be regarded as randomized samples (Koo and Li, 2016). A sample
of 20 (5 x the items to be tested) participants is recommended for use in test- retest
studies (Park et al., 2017) to ensure that the sample is representative of the wider
population. Once the data has been analyzed by the relevant clinician's the data will be
destroyed in line with trust policy.
The researcher will not be involved in the initial invitation of participants to the study
and will have no influence on who can join the study other than providing the inclusion and
exclusion criteria. The participants overall standard care will not be affected through
participation in the study inclusive if the recruitment process. In accordance with Good
Clinical Practice (GCP) we will ensure that participants understand fully the reason for the
study and their involvement.
Inclusion/exclusion criteria All participants aged 16 years or older who fulfill the
diagnostic criteria for neurofibromatosis 1, who do not have a significant mobility or
balance impairment that is unrelated to their neurofibromatosis 1, are able to walk more than
10 meters without physical assistance (may use walking aids), who are able to provide written
consent and who attend the national Neurofibromatosis service at GSTT will be eligible to
participate in the study.
Consent Participants will be recruited by the researcher (chief investigator) will obtain
written consent to participate in the study a from every individual after they have had at
least 24 hours to read the information sheet and the opportunity to ask questions about the
study. Consent will be obtained by the chief investigator who has attended Good Clinical
Practice Training.
Steps to reduce researcher bias To reduce the risk of selection bias, multiple clinicians
will be included in recruitment however, the researcher will not be involved in this process.
To reduce the risk of performance bias, the outcome measurements will all be collected by the
same Physiotherapist with standardized instructions.
To reduce the risk of detection bias, a statistician will review the statistical plan and the
data collected to ensure appropriateness and accuracy.
