Clinical trial · Observational
Reliability of Functional Outcome Measures in Neurofibromatosis 1: Test- Retest
A Study Investigating the Test- and Retest Reliability of a Battery of Functional Standardised Outcome Measures in Adults With Neurofibromatosis 1
NCT05186870CI-TRIAL-00064420unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibromatosis Type 1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Outcome measures | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (8)
- measure
- Timed 10 meter walk test.
- timeFrame
- Baseline
- description
- Time how long it takes the participant to walk for a distance of 10m
- measure
- Timed 10 meter Walk test.
- timeFrame
- 14 days
- description
- Time how long it takes the participant to walk for a distance of 10m
- measure
- Timed up and Go
- timeFrame
- Baseline
- description
- Time how long it takes the participant to stand up from a chair, walk 3m, turn around and return to sitting on the chair
- measure
- Timed up and Go
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who 1. fulfill the diagnostic criteria for neurofibromatosis 1 2. are aged 16 years or over 3. attend the national neurofibromatosis service at GSTT 4. are capable of providing informed consent 5. do not have any non neurofibromatosis 1 related co-morbidities that affect mobility or balance (confirmed with the treating clinician) 6. are able to walk more than 10 metres without assistance of a person (may use walking aid/orthotics) 7. 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. Exclusion Criteria: * Patients who 1. do not fulfill the diagnostic criteria for neurofibromatosis 1 2. are under the age of 16 years 3. are unable to provide informed consent 4. have non neurofibromatosis 1 related co-morbidities that affect mobility or balance (confirmed with the treating clinician) 5. are unable to walk more than 10 metres without assistance of a person (may use walking aid/orthotics) 6. 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. 7. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.