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Dose-Finding of Lower Limb Mirror Therapy After Stroke.

Primary Purpose

Stroke

Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
rehabilitation intervention
Sponsored by
University of East Anglia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Mirror therapy, Rehabilitation, Lower limb, Motor recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

  • Foot or ankle contracture that prevents 50% of the passive range of motion.
  • Any condition that can be exaggerated by performing the therapy.

Sites / Locations

  • Sarah Bajuaifer

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mirror therapy

Arm Description

lower limb mirror therapy using ankle exercise

Outcomes

Primary Outcome Measures

Changes in the Motricity Index

Secondary Outcome Measures

Changes in the Symmetry
in Tibialis anterior muscle activation between the more and less paretic leg
Changes in the Neural excitability
at the spinal level using peripheral nerve stimulation-H reflex
changes in the Transcranial magnetic stimulation (TMS)
Corticospinal tract excitability

Full Information

First Posted
March 23, 2020
Last Updated
November 5, 2021
Sponsor
University of East Anglia
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1. Study Identification

Unique Protocol Identification Number
NCT04339803
Brief Title
Dose-Finding of Lower Limb Mirror Therapy After Stroke.
Official Title
Dose-Finding of Lower Limb Mirror Therapy After Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
August 9, 2021 (Actual)
Study Completion Date
August 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of East Anglia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Mirror therapy, Rehabilitation, Lower limb, Motor recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mirror therapy
Arm Type
Experimental
Arm Description
lower limb mirror therapy using ankle exercise
Intervention Type
Other
Intervention Name(s)
rehabilitation intervention
Intervention Description
we use lower limb mirror therapy after stroke for two weeks
Primary Outcome Measure Information:
Title
Changes in the Motricity Index
Time Frame
Baseline, 2 weeks.
Secondary Outcome Measure Information:
Title
Changes in the Symmetry
Description
in Tibialis anterior muscle activation between the more and less paretic leg
Time Frame
Baseline, 2 weeks
Title
Changes in the Neural excitability
Description
at the spinal level using peripheral nerve stimulation-H reflex
Time Frame
Baseline, 2 weeks
Title
changes in the Transcranial magnetic stimulation (TMS)
Description
Corticospinal tract excitability
Time Frame
Baseline, 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Pomeroy, Professor
Organizational Affiliation
School of Health Sciences, University of East Anglia
Official's Role
Study Director
Facility Information:
Facility Name
Sarah Bajuaifer
City
Norwich
ZIP/Postal Code
NR4 7TJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participant data only will be shared with the research team

Learn more about this trial

Dose-Finding of Lower Limb Mirror Therapy After Stroke.

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