NCT05186870

Brief 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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 30, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2021

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

3.5 years

First QC Date

March 23, 2021

Last Update Submit

March 2, 2023

Conditions

Neurofibromatosis Type 1

Outcome Measures

Primary Outcomes (8)

  • Timed 10 meter walk test.

    Time how long it takes the participant to walk for a distance of 10m

    Baseline

  • Timed 10 meter Walk test.

    Time how long it takes the participant to walk for a distance of 10m

    14 days

  • Timed up and Go

    Time how long it takes the participant to stand up from a chair, walk 3m, turn around and return to sitting on the chair

    Baseline

  • Timed up and Go

    Time how long it takes the participant to stand up from a chair, walk 3m, turn around and return to sitting on the chair

    14 days

  • Functional reach test

    Requires 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.

    Baseline

  • Functional reach test

    Requires 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.

    14 days

  • Grip dynamometry

    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.

    Baseline

  • Grip dynamometry

    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.

    14 days

Interventions

Outcome measuresOTHER

Observational study

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants' attending to the National Centre for Neurofibromatosis at Guy's hospital between August 2019- October 2019, January 2020-March 2020 and May 2022 until October 2022 then January 2023- June 2023. With extensions due to multiple issues during the trial recruitment periods including COVID and staffing change related.

You may qualify if:

  • Patients who
  • fulfill the diagnostic criteria for neurofibromatosis 1
  • are aged 16 years or over
  • attend the national neurofibromatosis service at GSTT
  • are capable of providing informed consent
  • do not have any non neurofibromatosis 1 related co-morbidities that affect mobility or balance (confirmed with the treating clinician)
  • are able to walk more than 10 metres without assistance of a person (may use walking aid/orthotics)
  • Symptoms that have remained stable between the 2 testing sessions (14 days). This will be assessed with the use of a neurological examination (Power, Sensation, Co-ordination, proprioception and reflexes), the NFQOL questionnaire and a subjective question to the patient as to if they feel there have been any changes to their symptoms in the last 14 days (completed on a percentage, 0= no change, 100% large change impacting their function). The assessing clinician will determine if any change is a significant change based on a reduction in power of more than 1 point (Oxford scale 0-5) and if there is a significant change in scores in comparison with the published norms.

You may not qualify if:

  • Patients who
  • do not fulfill the diagnostic criteria for neurofibromatosis 1
  • are under the age of 16 years
  • are unable to provide informed consent
  • have non neurofibromatosis 1 related co-morbidities that affect mobility or balance (confirmed with the treating clinician)
  • are unable to walk more than 10 metres without assistance of a person (may use walking aid/orthotics)
  • Patients whose symptoms have not remained stable between the 2 testing sessions (14 days). This will be assessed with the use of a neurological examination (Power, Sensation, Co-ordination, proprioception and reflexes), the NFQOL questionnaire and a subjective question to the patient as to if they feel there have been any changes to their symptoms in the last 14 days (completed on a percentage, 0= no change, 100% large change impacting their function). The assessing clinician will determine if any change is a significant change based on The assessing clinician will determine if any change is a significant change based on a reduction in power of more than 1 point (Oxford scale 0-5) and if there is a significant change in scores in comparison with the published norms.
  • If the participant has been involved in research which may impact the testing (e.g. changes in treatment which may impact their symptoms during the trial/currently involved in a study completing the same outcome measures and adding a level of learned bias) then they will not be invited to join the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neurofibromatosis 1

Interventions

Outcome Assessment, Health Care

Condition Hierarchy (Ancestors)

NeurofibromatosesNeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplastic Syndromes, HereditaryNeurocutaneous SyndromesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Outcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Central Study Contacts

Amelia Khan, MSc

CONTACT

020 7188 5088amelia.khan@gstt.nhs.uk

Rosalie Ferner, Professor

CONTACT

02071883956Rosalie.ferner@gstt.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

January 11, 2022

Study Start

November 30, 2019

Primary Completion

June 1, 2023

Study Completion

July 1, 2025

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)