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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Mirror Therapy
  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

Первичные конечные точки

• Participant Recruitment Rate [Срок оценки: Baseline]
• Participant Enrolment Rate [Срок оценки: Baseline]
• Rate of Recruitment to Enrolment [Срок оценки: Baseline]
• Participant Retention Rate [Срок оценки: From baseline to the end of the intervention at 2 weeks]
• Participant Drop-out Rate [Срок оценки: From baseline to the end of the intervention at 2 weeks]
• Outcome Measure Practicality: Outcome Measure Completion Rate (Pre-intervention) [Срок оценки: Baseline]
• Outcome Measure Practicality: Outcome Measure Completion Rate (Post-Intervention) [Срок оценки: End of the intervention at 2 weeks]
• Data Collection Method Practicality: Conventional Physiotherapy Spreadsheet Completion rate [Срок оценки: End of the intervention at 2 weeks]
• Data Collection Method Practicality: Mirror Therapy Tolerability Form Completion rate [Срок оценки: End of the intervention at 2 weeks]
• Data Collection Method Practicality: Physiotherapist Interview [Срок оценки: Through study completion, up to 22 weeks]

Вторичные конечные точки (4)

• Fugl-Meyer Assessment - Lower Extremity (FMA-LE) [Срок оценки: Baseline and the end of the intervention at 2 weeks]
• Berg Balance Scale (BBS) [Срок оценки: Baseline and the end of the intervention at 2 weeks]
• 10-Meter-Walk-Test (10MWT) [Срок оценки: Baseline and the end of the intervention at 2 weeks]
• Modified Rivermead Mobility Index (MRMI) [Срок оценки: Baseline and the end of the intervention at 2 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Queen Elizabeth University Hospital — Glasgow

Идентификаторы

NCT: NCT06884709 · 348947

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗