Mirror Aided Cross Education in Post Stroke Upper Limb Rehabilitation.
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Mirror Strengthening Device; Mirror Therapy
Intervention type(s): Device; Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot Randomised Controlled Trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mirror Therapy; Cross-education Therapy; Rehabilitation