Clinical trial NCT06884709: Activity-based Mirror Therapy for Lower Limb Motor Recovery, Balance, Gait, and Mobility in Acute Inpatient Stroke: A Feasibility Study
Official title: Activity-based Mirror Therapy for Lower Limb Motor Recovery, Balance, Gait, and Mobility in Acute Inpatient Stroke: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
acute stroke
mirror therapy
lower limb hemiparesis
stroke rehabilitation
stroke physiotherapy
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This study will recruit participants that are inpatients at the Queen Elizabeth University Hospital in Glasgow. Participants will be screened according to eligibility criteria. For example, participants must be between 72 hours and 30 days post-stroke at the time of baseline assessment and have hemiparesis or hemiplegia of the lower limb.

After providing written informed consent, participants will receive activity-based mirror therapy for 15 minutes, three days per week for two weeks, in addition to 45 to 60 minutes of usual personalized conventional physiotherapy five days per week. The mirror therapy will be conducted by Glasgow Caledonian University (GCU) Doctorate of Physiotherapy (DPT) student Cassidy Flammang under the supervision of a qualified physiotherapist, while the conventional physiotherapy will be conducted by the qualified physiotherapists on the stroke rehabilitation ward.

The mirror therapy sessions will involve the participants sitting in a chair with a back, arm rests, and optional side supports, with their hips, knees, and ankles positioned at 90°. A 60 cm X 165 cm mirror will be placed in the midsagittal plane so that the non-paretic limb is reflected. The participants will be instructed to view the reflection in the mirror whilst conducting activity-based exercises with the non-paretic limb. They will be further instructed to imagine that the reflection of the non-paretic limb is their paretic limb, but to keep their paretic limb still. The exercises will target all major lower limb movements, except hip extension as that cannot be addressed whilst seated. The exercises will consist of 10-15 repetitions each of the following: 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 may take up to one minute of rest between exercises. Participants will be informed that they can take breaks or skip exercises at any point.

Lower limb motor recovery, balance, gait, and mobility will be assessed at baseline and upon completion of the two-week intervention. Mean differences will be determined to assess the change in test scores from pre- to post-intervention using a paired t-test, if normally distributed, or a Wilcoxon sign rank test if not. Both would have a significance level of p\<0.5.

Participants and physiotherapists involved in the study will also be asked to complete a short questionnaire and semi-structured interview to discuss the study and mirror therapy program. The interviews will be audio-recorded, with consent, and conducted by GCU DPT student Cassidy Flammang. They will then be transcribed and analyzed by thematic content analysis.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Participant Recruitment Rate
timeFrame: Baseline
measure: Participant Enrolment Rate
timeFrame: Baseline
measure: Rate of Recruitment to Enrolment
timeFrame: Baseline
measure: Participant Retention Rate
timeFrame: From baseline to the end of the intervention at 2 weeks
measure: Participant Drop-out Rate
timeFrame: From baseline to the end of the intervention at 2 weeks
measure: Outcome Measure Practicality: Outcome Measure Completion Rate (Pre-intervention)
timeFrame: Baseline
measure: Outcome Measure Practicality: Outcome Measure Completion Rate (Post-Intervention)
timeFrame: End of the intervention at 2 weeks
measure: Data Collection Method Practicality: Conventional Physiotherapy Spreadsheet Completion rate
timeFrame: End of the intervention at 2 weeks
measure: Data Collection Method Practicality: Mirror Therapy Tolerability Form Completion rate
timeFrame: End of the intervention at 2 weeks
measure: Data Collection Method Practicality: Physiotherapist Interview
timeFrame: Through study completion, up to 22 weeks
measure: Participant Acceptability of the Intervention: Participant Questionnaire
timeFrame: End of the Intervention at 2 weeks
measure: Participant Acceptability of the Intervention: Participant Interview
timeFrame: End of the Intervention at 2 weeks
measure: Physiotherapist Acceptability of Study: Physiotherapist Questionnaire
timeFrame: Through study completion, up to 22 months
measure: Physiotherapist Acceptability of Study: Physiotherapist Interviews
timeFrame: Through study completion, up to 22 months
measure: Intervention Tolerability: Completion Rate of Each Mirror Therapy Exercise
timeFrame: End of the intervention at 2 weeks
measure: Intervention Tolerability: Completion Rate of Entire Mirror Therapy Session
timeFrame: End of the intervention at 2 weeks
measure: Intervention Tolerability: Participant Interviews
timeFrame: The end of the intervention at 2 weeks
measure: Intervention Practicality: Average Weekly Amount of Conventional Physiotherapy Recieved
timeFrame: End of Intervention at 2 weeks
measure: Intervention Practicality: Average Weekly Amount of Mirror Therapy Recieved
timeFrame: End of Intervention at 2 weeks
measure: Intervention Practicality: Physiotherapist Interview
timeFrame: Through study completion, up to 22 months
measure: Adverse Events
timeFrame: From baseline to the end of the intervention at 2 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment - Lower Extremity (FMA-LE)
timeFrame: Baseline and the end of the intervention at 2 weeks
measure: Berg Balance Scale (BBS)
timeFrame: Baseline and the end of the intervention at 2 weeks
measure: 10-Meter-Walk-Test (10MWT)
timeFrame: Baseline and the end of the intervention at 2 weeks
measure: Modified Rivermead Mobility Index (MRMI)
timeFrame: Baseline and the end of the intervention at 2 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
state: Scotland
Study officials:
affiliation: Glasgow Caledonian University
name: Vicky Joshi, PhD
role: PRINCIPAL_INVESTIGATOR
References: