Dose-Finding of Lower Limb Mirror Therapy After Stroke.

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: rehabilitation intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Norwich, United Kingdom, NR4 7TJ
    • Sarah Bajuaifer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mirror therapy; lower limb mirror therapy using ankle exercise	Other: rehabilitation intervention; we use lower limb mirror therapy after stroke for two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in the Motricity Index	Baseline, 2 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Symmetry	in Tibialis anterior muscle activation between the more and less paretic leg	Baseline, 2 weeks
Changes in the Neural excitability	at the spinal level using peripheral nerve stimulation-H reflex	Baseline, 2 weeks
changes in the Transcranial magnetic stimulation (TMS)	Corticospinal tract excitability	Baseline, 2 weeks

Collaborators and Investigators

• Sponsor: University of East Anglia
• Investigators: Study Director: Valerie Pomeroy, Professor, School of Health Sciences, University of East Anglia

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): August 9, 2021
• Study Completion (Actual): August 9, 2021

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Motor recovery; Mirror therapy; Lower limb
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 255913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data only will be shared with the research team

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No