Trial Status: Open
Design:
A multi-centre, two-group, parallel, assessor-blinded, superiority, individually randomised controlled trial comparing FES in addition to usual care to usual care alone.
Group 1 (control group): this group will not receive any intervention from the study and will continue with their usual care.
Group 2 (FES + Usual Care): this group will wear the FES stimulator daily and use it with sufficient intensity to cause an active muscle movement of dorsiflexion and eversion for 18 weeks,followed by 4 weeks without using FES. This group will also continue with their usual care.
Recruitment and randomisation:
Participants will be recruited from seven different study centres across the UK with an established FES service, recruiting from contrasting rural and urban populations. Participants will be randomly allocated on a 1:1 basis to either Group 1 or Group 2 by a secure, web-based randomisation system provided by the Peninsula Clinical Trials Unit.
Participant identification:
There are two main routes by which a participant may be identified and recruited onto the study. These are via outpatient clinics or self-referral via the STEPS II webpage.
Potential participants may be identified by the local Movement Disorders Teams, PD clinics and neurology clinics. It is recommended that clinical teams review outpatient lists in order to identify any potential participants with upcoming appointments to improve participant identification and recruitment. The clinician will discuss the study with potential participants at their regular appointment, this my be a face-to-face appointment or virtual/telephone appointment, depending on the sites local arrangements. If the patient is interested, they will be provided with a recruitment pack containing a participant information sheets (PISs) describing the study and containing contact details of the local STEPS II research team. If the potential participant attends for a face-to-face appointment, the recruitment pack will be handed to them during the visit. If their appointment occurs virtually or over the telephone, the recruitment pack will be emailed or posted. Participants will be asked if they wish to be contacted by the research team in a few days to discuss the study further, and if so the best time of day to contact them. Patients who agree will receive a follow-up phone call at least 48 hours after receiving the PIS from a member of the STEPS II research team to discuss the study. If they do no