Specialty: Dementias and neurodegeneration, Primary sub-specialty: Parkinson's Disease
Conditions
Interventions
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 vis
Sponsors
Salisbury NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 to understand and comply with the treatment and assessment procedures 9. Able to give informed consent 10. Able to start using FES within 2 weeks
Exclusion criteria
Exclusion criteria: 1. Able to walk 10m in less than 8s (walking speed >1.25ms-1) indicating non limited functional walking 2. Other treatment than standard drug therapy (FES, deep brain stimulation, duodopa, apomorphine) 3. Atypical or secondary parkinsonism or parkinsonism related to other neurodegenerative diseases 4. Dropped foot due to any neurological condition other than Parkinson’s Disease 5. Untreated or refractory epilepsy 6. Pregnancy 7. Cardiac pacemaker, or other active medical implanted devices 8. Denervation of the common peroneal nerve 9. Malignancy or dermatological conditions in the area of the electrodes 10. Major cognitive impairment or dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| No secondary outcome measures. | — |
Countries
England, United Kingdom
Outcome results
None listed