Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT03736902
Eligibility Criteria:
Inclusion Criteria:
* Adults (age 18 or over)
* Confirmed diagnosis of Relapsing Remitting Multiple Sclerosis
* Confirmed relapse diagnosed by a consultant neurologist or specialist registrar.
* Relapse within the four months preceding interview date (as most recovery is expected to have occurred by this time)
* Expanded Disability Status Scale (EDSS) score of \<7. The EDSS is a 0 - 10 scale used to quantify disability in multiple sclerosis and monitor changes in level of disability over time. A score of 0 represents no disability. The scale is widely used in clinical trials and in the assessment of people with MS. A score of \<7 has been chosen as people with a score of ≥7 and above are unable to walk more than five metres and are restricted to a wheelchair for the majority of the daytime and are likely to find it much more difficult to engage in physical activity.
* Agree to be audio-recorded during the interviews
* Patients who speak competent English. This will be assessed initially by the clinical treating team, as patients who can communicate their relapse history in English during the clinic are assumed to have adequate English to participate in this study. In addition, the researcher is an experienced clinical physiotherapist who is exposed to a range of language abilities. If the researcher does not feel the participant has enough English skills to consent, then they will exclude the participant from the study.
Exclusion Criteria:
* Patients who are under the age of 18. Children represent less that 5% of PwMS and their experience is likely to be different to adults.
* Adults unable to participate in an interview spoken in English. Non-English speakers are unable to participate in the study as there are no funds for the hire of interpreters or health advocates, or for the translation of study information or consent documents. In order to gain informed consent, complete the demographic questions, questionnaires and participate in the qualitative interviews with the researcher, participants will need to be able to be able to speak and fluent English.
* People with co-morbidities impacting on physical function in the last year (e.g. heart disease, arthritis, musculoskeletal injury).
* Adults lacking mental capacity to consent to take part in the research.
* People who want to be interviewed at home but live greater than 40 miles radius from the National Hospital for Neurology and Neurosurgery.
* People with a relapse more than four months from the date of interview. This has been chosen so that people that are interviewed have had a recent relapse, with their recovery experience is still fresh in their memory.
* Pseudo-relapse (e.g. from urinary tract infection of lower respiratory tract infection).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03736902
Study Brief:
Protocol Section:
NCT03736902