Dose-Finding of Lower Limb Mirror Therapy After Stroke.

NCT04339803 | Completed Early Phase 1

• 1 other identifier: 255913
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Mirror therapy; Rehabilitation; Lower limb; Motor recovery

Outcome Measures

Primary Outcomes (1)

• Changes in the Motricity Index

  Baseline, 2 weeks.

Secondary Outcomes (3)

• Changes in the Symmetry

  Baseline, 2 weeks

• Changes in the Neural excitability

  Baseline, 2 weeks

• changes in the Transcranial magnetic stimulation (TMS)

  Baseline, 2 weeks

Study Arms (1)

mirror therapy

EXPERIMENTAL

lower limb mirror therapy using ankle exercise

Other: rehabilitation intervention

Interventions

rehabilitation intervention OTHER

we use lower limb mirror therapy after stroke for two weeks

mirror therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of East Anglia: lead

Study Sites (1)

Sarah Bajuaifer

Norwich, NR4 7TJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38237263 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Valerie Pomeroy, Professor

  School of Health Sciences, University of East Anglia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 9, 2020
• Study Start: April 23, 2019
• Primary Completion: August 9, 2021
• Study Completion: August 9, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)