Dose-Finding of Lower Limb Mirror Therapy After Stroke.

Stroke Clinical Trial

Official title:

Dose-Finding of Lower Limb Mirror Therapy After Stroke.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04339803
• Other study ID #: 255913
• Status: Completed
• Phase: Early Phase 1
• Start date: April 23, 2019
• Est. completion date: August 9, 2021

Study information

• Verified date: November 2021
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 9, 2021
• Est. primary completion date: August 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• rehabilitation intervention
we use lower limb mirror therapy after stroke for two weeks

Locations

Country	Name	City	State
United Kingdom	Sarah Bajuaifer	Norwich

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Motricity Index		Baseline, 2 weeks.
Secondary	Changes in the Symmetry	in Tibialis anterior muscle activation between the more and less paretic leg	Baseline, 2 weeks
Secondary	Changes in the Neural excitability	at the spinal level using peripheral nerve stimulation-H reflex	Baseline, 2 weeks
Secondary	changes in the Transcranial magnetic stimulation (TMS)	Corticospinal tract excitability	Baseline, 2 weeks