Dose-Finding of Lower Limb Mirror Therapy After Stroke.

Procedure:a 3+3 rule-based, dose-escalation design (Colucci et al,2017). recruitment process: the study will begin with a cohort of three participants (n=3). Each of the subsequent cohorts will also be of three participants. The start dose will be set at 15 minutes (cohort one). Participants will do ankle dorsiflexion exercise at the set dose with the mirror for two weeks. The second and subsequent cohorts will exercise at dose set in accordance to the nine preset rules and the modified Fibonacci sequence (mFBS) .

Sample size: The target sample size is not usually predefined for a dose-finding study. The final sample size will be determined by the response of consecutive cohorts to the set dose. Usually, in pharmaceutical dose-finding studies, the sample size lies between 12 and 40.

Data analysis : The data for each cohort will be analysed using descriptive statistics. No significance testing is involved.

Inclusion criteria

• Participants have had a stroke for six weeks or more before recruitment to this study, and are discharged from NHS statutory stroke rehabilitation.
• Participants will be at least 18 years of age
• Able to produce some voluntary contraction of paretic ankle ( motricity index between 9 and 19).
• Ability to understand and follow simple verbal instructions (one-stage commands), i.e. sufficient communication, orientation, and memory to participate in mirror therapy ankle exercise.
• Participants will have had no lower limb injury in the last six months and were able to walk independently indoors before the index stroke.

Exclusion criteria

• Foot or ankle contracture that prevents 50% of the passive range of motion.
• Any condition that can be exaggerated by performing the therapy.