Dose-Finding of Lower Limb Mirror Therapy After Stroke.

University of East Anglia

Status and phase

Completed

Early Phase 1

Conditions

Stroke

Treatments

Other: rehabilitation intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04339803

255913

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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