Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF, United Kingdom
NCT Number: NCT06884709
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Glasgow, Scotland, G51 4TF, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline
Average monthly recruitment rate (total number of people approached about the study ÷ the number of months recruitment was conducted)
Time frame: Baseline
Average monthly enrolment rate (number of patient participants that provided written consent ÷ the number of months recruitment was conducted)
Time frame: Baseline
Recruitment to enrolment success rate (number of patient participants enrolled ÷ number of patient participants approached)
Time frame: From baseline to the end of the intervention at 2 weeks
Retention Rate (number of participants that completed the entire two-week intervention ÷ number of enrolled participants)
Time frame: From baseline to the end of the intervention at 2 weeks
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:
Time frame: Baseline
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)
Time frame: End of the intervention at 2 weeks
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)
Time frame: End of the intervention at 2 weeks
Conventional physiotherapy spreadsheet completion rate (number of times the spreadsheet was successfully and fully filled out ÷ total number of sessions completed)
Time frame: End of the intervention at 2 weeks
Mirror therapy tolerability form completion rate (number of times the form was successfully and fully filled out ÷ total number of sessions completed)
Time frame: Through study completion, up to 22 weeks
Semi-structured interviews with the physiotherapists involved in the study to discuss the practicality of the data collection methods used in the study
Time frame: End of the Intervention at 2 weeks
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.
Time frame: End of the Intervention at 2 weeks
Semi-structured interviews with participants to discuss how acceptable participants found the intervention.
Time frame: Through study completion, up to 22 months
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.
Time frame: Through study completion, up to 22 months
Semi-structured interviews with the physiotherapists involved in the study to assess how acceptable they found the study and it's design
Time frame: End of the intervention at 2 weeks
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)
Time frame: End of the intervention at 2 weeks
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)
Time frame: The end of the intervention at 2 weeks
Semi-structured interviews with participants to discuss how tolerable they found the intervention.
Time frame: End of Intervention at 2 weeks
Average amount of conventional physiotherapy participants recieved per week (in minutes)
Time frame: End of Intervention at 2 weeks
Average amount of Mirror Therapy participants recieved per week (in minutes)
Time frame: Through study completion, up to 22 months
Semi-structured interviews with stroke physiotherapists involved in the study to discuss the practicality of implementing the intervention with the given dosage and design.
Time frame: From baseline to the end of the intervention at 2 weeks
What is it assessing?
Time frame: Baseline and the end of the intervention at 2 weeks
Assesses lower limb motor recovery. There is a maximum score of 34. A higher scores indicates better motor recovery.
Time frame: Baseline and the end of the intervention at 2 weeks
Assesses balance. It consists of 14 items on a five-point ordinal scale that ranges from 0 to 4. 0 represents the lowest level of function and 4 the highest. There is a maximum score of 56.
Time frame: Baseline and the end of the intervention at 2 weeks
Assesses gait. A 10 meter (m) walkway will have a 2 m acceleration and deceleration zone on each side. Thus the time (in seconds) taken to walk the central 6 meters will be measured, with speed calculated in m/s. This study will complete 1 trial at a comfortable speed
Time frame: Baseline and the end of the intervention at 2 weeks
Assesses mobility. The MRMI assesses 8 mobility activities on a six-point scale from 0 to 5, with 0 being unable and 5 independent. There is a maximum score of 40. This study will assess some of the activities concurrently with the BBS and 10MWT.
Contact information is provided by the study sponsor or research team.
Glasgow Caledonian University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07705256
Brain Diseases, Cardiovascular Diseases
London, United Kingdom
View Trial DetailsNCT07741669
Brain Diseases, Cardiovascular Diseases
Beijing, China
View Trial DetailsNCT07735676
Brain Diseases, Cardiovascular Diseases
Dhaka, Bangladesh
View Trial DetailsNCT07735702
Brain Diseases, Cardiovascular Diseases
Dhaka, Bangladesh
View Trial Details