Activity-based Mirror Therapy for Lower Limb Motor Recovery, Balance, Gait, and Mobility in Acute Inpatient Stroke: A Feasibility Study

NCT06884709 | Not Yet Recruiting

• 1 other identifier: 348947
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility study is the first step of a larger effects study exploring the use of an activity-based mirror therapy program for people who have had a stroke in the last 30 days and are in the hospital. The study aims to examine features of the study design as well as the preliminary effects of the mirror therapy program on motor recovery, balance, gait, and mobility. In this study participants will complete 15 minutes of lower limb mirror therapy three days per week for two weeks, alongside their usual physiotherapy. The motor recovery, balance, gait, and mobility of participants will then be reassessed. Participants will also be invited to complete a short questionnaire and interview about their experience in the study. Stroke physiotherapists that are involved in the study will also complete a questionnaire and interview to provide feedback on the study and it's design.

Conditions

Stroke

Keywords

stroke; acute stroke; mirror therapy; lower limb hemiparesis; stroke rehabilitation; stroke physiotherapy

Outcome Measures

Primary Outcomes (21)

• Participant Recruitment Rate

  Average monthly recruitment rate (total number of people approached about the study ÷ the number of months recruitment was conducted)

  Baseline

• Participant Enrolment Rate

  Average monthly enrolment rate (number of patient participants that provided written consent ÷ the number of months recruitment was conducted)

  Baseline

• Rate of Recruitment to Enrolment

  Recruitment to enrolment success rate (number of patient participants enrolled ÷ number of patient participants approached)

  Baseline

• Participant Retention Rate

  Retention Rate (number of participants that completed the entire two-week intervention ÷ number of enrolled participants)

  From baseline to the end of the intervention at 2 weeks

• Participant Drop-out Rate

  Drop-out rate (number of participants that did not complete the entire two-week intervention ÷ number of enrolled participants) The number of participants that did not complete the entire two-week intervention will then by further broken down and analyzed for the following categories: * Dropped out of study on own volition * Withdrawn from the study due to medical complications, cognition/aphasia regression, or death * Discharged from the stroke ward during the two-week intervention

  From baseline to the end of the intervention at 2 weeks

• Outcome Measure Practicality: Outcome Measure Completion Rate (Pre-intervention)

  Pre-intervention outcome measure completion rate (number of times each effects outcome measure was fully completed at baseline ÷ number of times each effects outcome measure was attempted at baseline)

  Baseline

• Outcome Measure Practicality: Outcome Measure Completion Rate (Post-Intervention)

  Post-intervention outcome measure completion rate (number of times each effects outcome measure was fully completed post-intervention ÷ number of times each effects outcome measure was attempted post-intervention)

  End of the intervention at 2 weeks

• Data Collection Method Practicality: Conventional Physiotherapy Spreadsheet Completion rate

  Conventional physiotherapy spreadsheet completion rate (number of times the spreadsheet was successfully and fully filled out ÷ total number of sessions completed)

  End of the intervention at 2 weeks

• Data Collection Method Practicality: Mirror Therapy Tolerability Form Completion rate

  Mirror therapy tolerability form completion rate (number of times the form was successfully and fully filled out ÷ total number of sessions completed)

  End of the intervention at 2 weeks

• Data Collection Method Practicality: Physiotherapist Interview

  Semi-structured interviews with the physiotherapists involved in the study to discuss the practicality of the data collection methods used in the study

  Through study completion, up to 22 weeks

• Participant Acceptability of the Intervention: Participant Questionnaire

  Participant acceptability questionnaire to assess how acceptable participants found the intervention. The questionnaire was adapted from Sekhon, Cartwright, and Francis' 2022 theoretical framework of acceptability informed questionnaire for healthcare interventions.

  End of the Intervention at 2 weeks

• Participant Acceptability of the Intervention: Participant Interview

  Semi-structured interviews with participants to discuss how acceptable participants found the intervention.

  End of the Intervention at 2 weeks

• Physiotherapist Acceptability of Study: Physiotherapist Questionnaire

  Physiotherapist acceptability questionnaire to assess how acceptable the stroke physiotherapists found the study and it's design. The questionnaire was adapted from Sekhon, Cartwright, and Francis' 2022 theoretical framework of acceptability informed questionnaire for healthcare interventions.

  Through study completion, up to 22 months

• Physiotherapist Acceptability of Study: Physiotherapist Interviews

  Semi-structured interviews with the physiotherapists involved in the study to assess how acceptable they found the study and it's design

  Through study completion, up to 22 months

• Intervention Tolerability: Completion Rate of Each Mirror Therapy Exercise

  Completion rate of each mirror therapy exercise (number of times each individual mirror therapy exercise was completed in full ÷ total number of mirror therapy sessions)

  End of the intervention at 2 weeks

• Intervention Tolerability: Completion Rate of Entire Mirror Therapy Session

  Completion rate of entire 15-minute mirror therapy session (number of times the entire mirror therapy was completed in full (no skipped exercises) ÷ total number of mirror therapy sessions)

  End of the intervention at 2 weeks

• Intervention Tolerability: Participant Interviews

  Semi-structured interviews with participants to discuss how tolerable they found the intervention.

  The end of the intervention at 2 weeks

• Intervention Practicality: Average Weekly Amount of Conventional Physiotherapy Recieved

  Average amount of conventional physiotherapy participants recieved per week (in minutes)

  End of Intervention at 2 weeks

• Intervention Practicality: Average Weekly Amount of Mirror Therapy Recieved

  Average amount of Mirror Therapy participants recieved per week (in minutes)

  End of Intervention at 2 weeks

• Intervention Practicality: Physiotherapist Interview

  Semi-structured interviews with stroke physiotherapists involved in the study to discuss the practicality of implementing the intervention with the given dosage and design.

  Through study completion, up to 22 months

• Adverse Events

  What is it assessing? * Assesses if the participants experienced any adverse events throughout the study How is it Measured? * Participants will be asked about adverse events (related or unrelated to the intervention) at the beginning and end of each mirror therapy session. This will be recorded on the mirror therapy tolerability form.

  From baseline to the end of the intervention at 2 weeks

Secondary Outcomes (4)

• Fugl-Meyer Assessment - Lower Extremity (FMA-LE)

  Baseline and the end of the intervention at 2 weeks

• Berg Balance Scale (BBS)

  Baseline and the end of the intervention at 2 weeks

• 10-Meter-Walk-Test (10MWT)

  Baseline and the end of the intervention at 2 weeks

• Modified Rivermead Mobility Index (MRMI)

  Baseline and the end of the intervention at 2 weeks

Study Arms (1)

Mirror Therapy Group

EXPERIMENTAL

For 15 minutes, three days per week for two weeks, participants will complete activity-based exercises with their non-paretic lower limb whilst watching the reflection of this limb in a mirror that is placed in their mid-sagittal plane. They will also receive 45 to 60 minutes of usual personalized conventional physiotherapy five days per week.

Other: Mirror Therapy

Interventions

Mirror Therapy OTHER

During mirror therapy, participants will sit in an arm chair with a mirror placed in their mid-sagittal plane so that their non-paretic lower limb is reflected and their paretic lower limb is hidden. They will be asked to complete activity-based exercises with their non-paretic limb whilst watching the reflection in the mirror and imagining the reflection is their paretic limb. The activity-based exercises consist of rocker board dorsi/plantarflexion, rocker board in/eversion, step ups, wiping floor (or ball rolling) in/external hip rotation, wiping floor ab/adduction, ball kicking, and picking up marbles with the toes. Participants will do these exercises for 15 minutes, three days per week for four weeks. Participants will also receive 45 to 60 minutes of usual personalized conventional physiotherapy such as neurodevelopmental facilitation, sensory motor re-education, active/active-assisted exercises, and balance/gait training, five days per week.

Mirror Therapy Group

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older
• Diagnosis of hemorrhagic or ischemic stroke by head computed tomography (CT) or magnetic resonance imaging (MRI)
• Medically stable to participate in physical rehabilitation as determined by the medical staff at QEUHSRU providing approval to begin physiotherapy
• Between 72 hours and 30 days post stroke at the time of baseline assessment
• Hemiparesis or hemiplegia of lower limb
• Ability to maintain sitting balance in a chair with arm rests, a back, and optional side support while moving the lower limb
• Ability to ambulate with or without a walking aide prior to stroke
• No cognitive impairment that affects the ability to interact with the intervention or provide informed consent, as determined by the potential participant's medical team. To further ensure participants remain cognitively capable throughout the study, participants will be asked to briefly explain the study before providing consent and before each mirror therapy session
• No severe aphasia that would impair the participants ability to understand the instructions of the intervention or prevent them from providing continuous verbal feedback throughout the intervention. This will be determined by the potential participant's care team. To further ensure potential participants are not aphasic they will be asked to briefly being able to explain the study back to the research team prior to providing written consent and before each mirror therapy session
• No severe uncorrected visual impairments that would prevent viewing the image in the mirror
• No severe cardiopulmonary or musculoskeletal impairments that inhibit seated exercises of the non-paretic limb

You may not qualify if:

• Individuals with any type of lower limb amputation of either side of the body
• Individuals who have been identified as having incapacity by their medical team, as aligned with the Adults with Incapacity (Scotland) Act 2000
• Non-English Speakers
• Individuals who's care teams identified them as being distressed during their routine assessments/sessions

Sponsors & Collaborators

• Glasgow Caledonian University: lead

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Vicky Joshi, PhD

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassidy Flammang, DPT student

CONTACT

+4407481988475; cflamm300@caledonian.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 19, 2025
• Study Start: April 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)