NCT04339803

Dose-Finding of Lower Limb Mirror Therapy After Stroke.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of East Anglia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the maximum dose per day of using mirror therapy for ankle exercise after stroke. The design is a 3+3 rule based, dose- finding study. Each cohort will consist of three participants. The first cohort will be assigned to do a dose of 15 minutes each day for two weeks. The second and subsequent cohorts will exercise at target dose set accordance to the nine preset rules and the modified Fibonacci sequence (mFBS).The study will continue until the stopping rule is triggered. The last dose tested will be identified as the maximum tolerable dose per day.

Detailed description

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.

Conditions

• Stroke

Interventions

Type	Name	Description
OTHER	rehabilitation intervention	we use lower limb mirror therapy after stroke for two weeks

Timeline

• Start date: 2019-04-23
• Primary completion: 2021-08-09
• Completion: 2021-08-09
• First posted: 2020-04-09
• Last updated: 2021-11-08

Locations

1 site across 1 country: United Kingdom