Dose-Finding of Lower Limb Mirror Therapy After Stroke. | NCT04339803

Studies
Dose-Finding of Lower Limb Mirror Therapy After Stroke.

NCT04339803

Sponsor

University of East Anglia

Status

Completed

Last Update Posted

Nov 8, 2021Actual

Enrollment

19Actual

Phase

Early Phase 1

Conditions

Stroke

Interventions

rehabilitation intervention

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 23, 2019Actual

Primary Completion Date

Aug 9, 2021Actual

Completion Date

Aug 9, 2021Actual

First Submitted Date

Mar 23, 2020

First Submission Date that Met QC Criteria

Apr 6, 2020

First Posted Date

Apr 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2021

Last Update Posted Date

Nov 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mirror therapy	Experimental	lower limb mirror therapy using ankle exercise	Other: rehabilitation intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rehabilitation intervention	Other	we use lower limb mirror therapy after stroke for two weeks	mirror therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Valerie Pomeroy, Professor	School of Health Sciences, University of East Anglia	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sarah Bajuaifer		Norwich		NR4 7TJ	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38237263	Derived	Bajuaifer S, Grey MJ, Hancock NJ, Chandler E, Pomeroy VM. Maximum tolerable daily dose of mirror movement therapy ankle exercises after stroke: an early phase dose screening study. Physiotherapy. 2024 Mar;122:30-39. doi: 10.1016/j.physio.2023.10.007. Epub 2023 Nov 4.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases