This is a pilot randomised controlled trial investigating a combination of mirror therapy and cross-education training compared to mirror therapy alone for the rehabilitation of upper limb impairment following a stroke. A case study series will be completed in advance of the full randomised controlled trial. The outcome measure assessments will take place at the institution. All intervention therapy sessions will be completed by the participant in their own home with the first introductory session being completed with the lead researcher. The study will be conducted in conjunction with Sligo University Hospital once it has attained ethical approval through the relevant University Hospital Ethics Committee.
The study will require participants with chronic stroke to perform an upper limb Home Exercise Program (HEP) in their own home. INTERVENTION: Experimental Group Experimental participants will perform task-specific upper limb exercises while in a seated position at their kitchen table. During the exercises, participants will pull a resistance cord with their non-affected arm, while looking at its reflection in a mirror covering their affected arm. The untrained limb will be positioned in a similar position to the training limb, supported on the table behind the exercise device. Examples of the exercises include bringing the arm out to the side and up in the air (reaching style movement). The initial resistance will be chosen based on the participant's initial outcome measure results. Repetitions of these exercises will be prescribed according to patient function and strength and will be increased each week as their ability improves. Sessions will start with 20-minute durations and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes. Control Group Control participants will perform task-specific upper limb exercises while in a seated position at their kitchen table. During the exercises, participants will be watching their non-affected arm reflected in a mirror covering their affected arm. The untrained limb will be positioned in a similar position to the training limb, supported on the table behind the exercise device. Examples of the exercises include bringing the arm out to the side and up in the air (reaching style movement). Repetitions of these exercises will be prescribed according to patient function and strength and will be increased each week as their ability improves. Sessions will start with 20-minute durations and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes. Positioning * Participants will be seated in a chair in front of a table in their own home. * The untrained limb will be positioned in a similar position to the training limb supported on the table behind the exercise device with the shoulder slightly flexed forward to allow this positioning. Training duration \& frequency -20-30 minutes, 5/week for 4 weeks = total 20 sessions. Based on the average length and frequency of interventions in studies reported by a Cochrane Review for mirror therapy and the duration of 2 similar previous studies involving unilateral strengthening. Compliance: The participants will be provided with an exercise diary in which they will record when they completed their exercises and how many repetitions they completed. If they did not complete their exercises there will be space to explain why not. They will also be sent a reminder text message by the lead researcher (Claire Smyth) on the proposed day of their exercises as a prompt/reminder. Block Randomisation The Design is an assessor-blinded, randomised control trial. The assessor, who is blinded to the treatment assignment will perform all the assessments After baseline measurements are obtained, the patients will be randomly assigned to the intervention or control group using computer-generated block random numbers where gender and function (based on the Fugl Meyer Upper Extremity Test) will be considered. A statistician who will be blinded to the research protocol and not otherwise involved in the trial will conduct the random number programme. The assignment of patients to experimental and control groups will be contained in opaque sealed envelopes that will be numbered 1-24 and the principle researcher will only inform each participant what group they are in post-baseline testing. Adverse Effects: Record any changes before and after each training session in the HEP record book Contact the Principal Researcher
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Participants will perform resisted task-specific upper limb exercises. During the exercises, participants will pull a resistance cord with their non-affected arm, Participants will complete the exercises while looking at its reflection in a mirror covering their affected arm. The initial resistance will be chosen based on the participants initial outcome measure results. Repetitions of these exercises will be prescribed according to patient function and strength, and will be increased each week as their ability improves. Sessions will start with 20-minute durations, and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes. Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions.
Participants will perform non-resisted task-specific upper limb exercises. During the exercises, participants will be watching their non affected arm reflected in a mirror covering their affected arm. Repetitions of these exercises will be prescribed according to patient function and strength, and will be increased each week as their ability improves. Sessions will start with 20-minute durations, and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes. Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions.
ATU Sligo
Sligo, Co Sligo, Ireland
Isokinetic Upper Limb Strength
(Biodex System 4 Pro with advantage software) IPRS Limited, Suffolk House, Bramford Road, Little Blakenham, Suffolk, IP8 4JU. A higher score indicates more strength.
Time frame: 4 weeks.
Upper limb range of movement.
Goniometer placed with centre over joint axis and each arm aligned with the measuring limbs. Range 0-180 degrees with a higher score indicating more range of motion.
Time frame: 4 weeks.
Modified Ashworth Scale (MAS) for spasticity.
Passive movement of each limb and joint movement carried out by the investigator. Scale is 0-5. A higher score indicates higher levels of spasticity/tone.
Time frame: 4 weeks.
Stroke Impact Scale measures Handicap.
Self reported questionnaire that evaluates disability and health related quality of life after stroke. The scale contains 59 questions which are answered on a scale of 1-5. A higher score indicates better function.
Time frame: 4 weeks.
Fugl Meyer Upper Extremity Test
A stroke specific performance based impairment index. The Test assesses 5 domains using a 3 point scale where a higher score again indicates more function.
Time frame: 4 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.