Can electrical stimulation of muscles be used to improve walking for people with Parkinson’s disease?

INTERVENTION: Sixty‐eight people with gait deficit due to idiopathic PD will be recruited. All participants will continue with usual care. In general, this comprises medication, attendance at medical clinics or visits from PD nurses. Exercise therapy may be accessed by individuals although this is not routinely prescribed. Participants will record usual care during the 22 week study. The participants will be randomly allocated using computer generated randomisation to one of two groups. Group 1 (control group): Participants will not receive any additional intervention over their usual care. Group 2 (FES): Participants will use the device in addition to their usual care. FES will be delivered using a device called the ODFS Pace. Self‐adhesive electrodes are placed over common peroneal nerve at its most superficial point just below the head of fibula. Stimulation is timed to the gait cycle using a pressure sensitive footswitch placed in the shoe and cause a contraction in the muscles that lift the foot and stabalise the ankle. As the foot is brought forward. The stimulator will be used daily when walking, throughout the intervention period. Participants will be taught to use the device over two clinic appointments with follow up 6 and 18 weeks. Both groups will be assessed at weeks 0, 6, 18 and 22, (4 weeks after withdrawal of the device from group 2), by an assessor blind to the group allocation. CONDITION: Specialty: Dementias and neurodegeneration, Primary sub‐specialty: Parkinson's Disease; UKCRC code/ Disease: Neurological/ Other disorders of the nervous system ; Nervous System Diseases ; Parkinson's disease PRIMARY OUTCOME: 1. Recruitment rate is determined by comparing the number of people with PD in each service, the number of people approached and issued with and information sheet and the number of people who come forward for assessment with the number of people who are consented on to the study at baseline; 2. Willingness to be randomised will be assessed by recording the number of people who drop out of the study because of what they consider unfavourable group allocation will be recorded, and through qualitative interviews with potential participants who do not wish to take part at or around baseline; 3. Loss‐to‐follow rates will be determined by comparison of the number of participants who are consented for the study with the number of participants who complete the 22 week assessment; 4. Participant views on obstacles to recruitment and retention in study using semi structure qualitative interviews at the beginning and end of the study; 5. Participant views on what would constitute a meaningful primary outcome measure using semi structure qualitative interviews at the beginning and end of the study and study questionnaire at week 18 SECONDARY OUTCOME: No secondary outcome measures. INCLUSION CRITERIA: 1. Aged 18 years and above (no upper age limit) 2. Idiopathic Parkinson’s disease 3. Hoehn and Yahr stages I to IV under medication 4. Difficulty with gait (clinical observation by experienced clinician): 4.1. Reduced dorsiflexion or eversion at any point in the swing or weight acceptance phase of gait, 4.2. Bradykinesia demonstrated by a measured 10m walking speed of less than 1.25ms‐1 4.3. Festination demonstrated by walking with short rapid strides 4.4. Akinesia demonstrated by exhibiting freezing episodes while walking. This may be in restricted areas such as doorways. 4.5. Hypokinesia demonstrated by walking with a short stride length 5. Able to walk 10m with appropriate walking aids but without assistance from another person 6. Able to obtain standing from sitting without the assistance of another person. 7. Medically stable defined as no significant changes in the participants condition over the last 3 months 8. Able