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Dose-Finding of Lower Limb Mirror Therapy After Stroke.

NCT ID: NCT04339803

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-23

Study Completion Date

2021-08-09

Brief Summary

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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

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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

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Stroke

Keywords

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Mirror therapy Rehabilitation Lower limb Motor recovery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mirror therapy

lower limb mirror therapy using ankle exercise

Group Type EXPERIMENTAL

rehabilitation intervention

Intervention Type OTHER

we use lower limb mirror therapy after stroke for two weeks

Interventions

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rehabilitation intervention

we use lower limb mirror therapy after stroke for two weeks

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of East Anglia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valerie Pomeroy, Professor

Role: STUDY_DIRECTOR

School of Health Sciences, University of East Anglia

Locations

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Sarah Bajuaifer

Norwich, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 38237263 (View on PubMed)

Other Identifiers

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255913

Identifier Type: -

Identifier Source: org_study_id