Clinical trial NCT02276729: Mirror Box Therapy for Upper Limb Function With Stroke
Official title: A Pilot Randomized Controlled Trial (RCT) of Mirror Box Therapy in Upper Limb Rehabilitation With Sub-acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident (CVA)
Stroke
Keywords: Upper limb
Rehabilitation
Occupational Therapy
Mirror Box Therapy
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Northern Health and Social Care Trust
First posted: 2014-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Individuals who have sustained a stroke are often left with residual deficits of the upper limb such as impaired movement and sensation. These deficits restrict functional use of the limb in everyday activities and can result in increased dependency upon others to engage in some tasks. Regaining independence through functional use of the arm and hand is an aim of occupational therapy rehabilitation. Mirror box therapy (MBT) is a relatively new innovation being introduced into occupational therapy interventions. Some studies have reported it to be beneficial in upper limb rehabilitation, however, these studies have not involved a sub-acute stroke population. This pilot study aims to provide robust evidence, using RCT design, as to whether this type of therapy may offer greater potential in functional gains in the sub-acute recovery period of stroke than standard rehabilitation of the upper limb alone.

Detailed description: Introduction. Stroke is a major cause of mortality in the United Kingdom with around 111,000 people per year being newly diagnosed. Of the survivors, 50% will be left with significant, long-term effects including residual deficits of the upper limb. Rehabilitation of upper limb impairment rests with the OT who plays a vital role in enabling stroke patients to self-manage their condition and live optimally independent lives. Mirror box therapy (MBT) is a relatively new therapeutic intervention that is gaining recognition within OT for the potential it offers in rehabilitation of upper limb function in stroke patients. Based upon mirror visual feedback originally used in the treatment of phantom limb pain after amputation, neural recovery in the brain can be stimulated using mirrored movements of the non-affected upper limb. It is thought that visual feedback helps recruit dormant motor pathways that replace the damaged pathways and encourage the return of movement, thus mirror box therapy is thought to improve upper limb function through both movement and mental stimulation. However, existing studies are limited due to non- consistent participant post-stroke delay (ranging from 3-12 months). Few studies have included patients in the sub- acute period post stroke (0-3 months), a population considered most likely to benefit from this therapy at the early recovery stage.

Aims and Objectives. The aim of this pilot study is therefore to explore the feasibility of conducting a fully powered randomized controlled trial of mirror box therapy for upper limb rehabilitation within a sub-acute stroke population.

The objectives of the study are to:

1. Evaluate the feasibility of patient recruitment within an in-patient sub-acute single setting;
2. Assess the feasibility of delivering MBT as a component of OT treatment in the sub-acute in-patient population;
3. Evaluate the sensitivity of the outcome measures for use in a fully powered trial and conduct a power calculation;
4. Conduct a preliminary analysis of the data to identify potential treatment gains within and between the 2 groups;
5. Pilot the collection of data to enable cost-consequence analysis to be undertaken as an output of the main RCT.

Sample: 50 participants will be recruited and randomized into two groups (treatment n=25; control n=25) over a 2 year period of 1 January 2015 - 31st Dec 2016.

Sample Size Justification: This sample size will allow us to estimate a standard deviation for the primary outcome, and allow us to estimate participation rate with a precision of +/-12.5% if, as we expect, the rate is in the vicinity of 75%.

Randomization: Block randomization will be undertaken using a computer generated randomization list. Each block is estimated to run over a 16 week period. This will allow for recruitment of between 1-2 new subjects per week and assumes an average inpatient stay of 6 weeks. Group allocation will be concealed in consecutively numbered, opaque sealed envelopes.

Intervention: Participants in both groups shall receive their standard OT treatment for upper limb rehabilitation for the duration of their in-patient stay, which is 3-5 sessions per week of approximately 45 minutes duration. This classic rehabilitation treatment is based upon neurodevelopmental theory using the Bobath approach of postural control and repetitive task training. Participants in the treatment group will be additionally required to perform two 20-minute sessions of mirror box therapy, five days/week for the duration of their in-patient stay. Also based upon neurodevelopmental theory, this treatment creates the illusion of perfect bilateral synchronization of repetitive task training by concealing the affected arm in a mirrored box that reflects the repetitive upper arm movements conducted by the unaffected limb.

Control Group Intervention: Participants will receive standard Occupational Therapy intervention for this population in the sub-acute rehabilitation setting, delivered by members of the OT stroke team. This follows the documented protocol used within the Health and Social Care Trust and progresses through 8 phases from assisted to unassisted movements, gross upper limb movements to wrist and fine finger movement, using remedial and functional activities as well as ward-level rehabilitation.

Treatment Group: Participants in the intervention group will be required to perform two 20 minute sessions of MBT, five days/week for the duration of their in-patient stay carried out under the direction of members of the OT stroke team. Sessions will be conducted at the patient's bedside or in the OT Department. Participants will be seated in a comfortable high chair and positioned in front of an adjustable height table. The mirror box will be positioned on the table in front of the participant. The participant will place or be assisted by the therapist to place the affected arm into the open end section of the nylon box; the mirror section will face the patient's non affected side.

Follow-up data period: We will follow up the initial blocks at both 3 and 6 monthly intervals in order to collect longer term data for use on sustained functional gain as well as for use in economic analysis. We will attempt to follow up as many subjects as possible in the latter blocks at the 3 \& 6 monthly intervals.

Analysis: Participation rates to both the complete set of assessments, and to the paired baseline and discharge assessments will be estimated and reported. If compliance to the complete set is similar to compliance with baseline and discharge, then assessment every two weeks will be considered for the main trial. However, if compliance with baseline and discharge falls below 60% this will question the value of conducting a larger study. Differences from baseline at discharge will be analysed using ANCOVA, with baseline assessment as the covariate. The upper 90% limit of the estimated sd will be used in future power calculation. The data from multiple assessments will be analysed using repeated measures ANOVA, and the estimated within and between patient sd used in future calculation. Confidence intervals will be presented for treatment effects, and the upper 95% limits used to inform future planning. The qualitative analysis of the patient exit questionnaire will consist of thematic analysis and synthesis.

Economic Analysis: If the subsequent main RCT demonstrates effectiveness of MBT, then analysis of relative costs and outcomes of the intervention will be demonstrable through a cost-consequence analysis using cost and outcome data gathered through the EQ-5D-5L and information relating to discharge destination and discharge care plans.

Ethics and Data Protection: Ethical approval will be obtained from ORECNI and full research governance approvals before commencement of this project.

Eligibility criteria: Inclusion Criteria:

* 18 years and over;
* newly admitted inpatient of the rehabilitation ward;
* diagnosis of CVA in the last three months resulting in upper limb motor loss;
* able to follow two part spoken or written commands in the English language;
* upper limb therapy designated as a main portion of goal directed treatment programme;
* consent to take part in the study.

Exclusion Criteria:

* patients who have had a previous CVA
* patients who have gross cognitive impairment
* patients who are unable to understand two part spoken/ written commands in English.

Primary outcomes:
measure: Change in Functional Independence Measure v4 at 6 weeks
timeFrame: Baseline and 6 weeks.
measure: Change in Functional Independence Measure v4 at 3 months post-discharge
timeFrame: Baseline and 3 months
measure: Change in Functional Independence Measure v4 at 6 months post-discharge
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Graded Wolf Motor Function Test (gWMFT) at 6 weeks
timeFrame: Baseline and 6 weeks.
measure: Change in Graded Wolf Motor Function Test (gWMFT) at 3 months post-discharge
timeFrame: Baseline and 3 months.
measure: Change in Graded Wolf Motor Function Test (gWMFT) at 6 months post-discharge
timeFrame: Baseline and 6 months.
measure: Change in EQ-5D-5L15 at 6 weeks
timeFrame: Baseline and 6 weeks.
measure: Change in EQ-5D-5L15 at 3 months post-discharge
timeFrame: Baseline and 3 months.
measure: Change in EQ-5D-5L15 at 6 months post-discharge
timeFrame: Baseline and 6 months.
measure: Change in Canadian Occupational Performance Measure (COPM) at 3 months post-discharge
timeFrame: Baseline and 3 months.
measure: Change in Canadian Occupational Performance Measure (COPM) at 6 months post-discharge
timeFrame: Baseline and 6 months.
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Whiteabbey Hospital, Northern Health and Social Care Trust
state: Co Antrim
Study officials:
affiliation: University of Ulster, Northern Ireland
name: Alison Porter-Armstrong, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scarborough P, Peto V, Bhatnagar P, et al (2009) Stroke Statistics. Dept of Public Health, University of Oxford.
citation: Higgins J, Mayo NE, Desrosiers J, Salbach NM, Ahmed S. Upper-limb function and recovery in the acute phase poststroke. J Rehabil Res Dev. 2005 Jan-Feb;42(1):65-76. doi: 10.1682/jrrd.2003.10.0156.
citation: Allied Health Professions Federation (2005). The role of allied health professionals in the treatment and management of people with long term conditions. London: Allied Health Professions Federation
citation: Intercollegiate Stroke Working Party (ISWP) (2008), National Clinical Guideline for Stroke. 3rd edition. London, UK: Royal College Physicians
citation: Intercollegiate Stroke Working Party (ISWP) (2012). National Clinical Guideline for Stroke. 4th edition. London, UK: Royal College Physicians
citation: Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6. doi: 10.1016/s0140-6736(99)00920-4. No abstract available.
citation: Yavuzer G, Selles R, Sezer N, Sutbeyaz S, Bussmann JB, Koseoglu F, Atay MB, Stam HJ. Mirror therapy improves hand function in subacute stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2008 Mar;89(3):393-8. doi: 10.1016/j.apmr.2007.08.162.
citation: Ramachandran VS, Rogers-Ramachandran D. Synaesthesia in phantom limbs induced with mirrors. Proc Biol Sci. 1996 Apr 22;263(1369):377-86. doi: 10.1098/rspb.1996.0058.
citation: Stevens JA, Stoykov ME. Using motor imagery in the rehabilitation of hemiparesis. Arch Phys Med Rehabil. 2003 Jul;84(7):1090-2. doi: 10.1016/s0003-9993(03)00042-x.
citation: Uswatte G, Taub E, Morris D, Vignolo M, McCulloch K. Reliability and validity of the upper-extremity Motor Activity Log-14 for measuring real-world arm use. Stroke. 2005 Nov;36(11):2493-6. doi: 10.1161/01.STR.0000185928.90848.2e. Epub 2005 Oct 13.
citation: Dohle C, Pullen J, Nakaten A, Kust J, Rietz C, Karbe H. Mirror therapy promotes recovery from severe hemiparesis: a randomized controlled trial. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):209-17. doi: 10.1177/1545968308324786. Epub 2008 Dec 12.
citation: Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.
citation: Oujamaa L, Relave I, Froger J, Mottet D, Pelissier JY. Rehabilitation of arm function after stroke. Literature review. Ann Phys Rehabil Med. 2009 Apr;52(3):269-93. doi: 10.1016/j.rehab.2008.10.003. Epub 2009 Apr 9. English, French.
citation: Granger CV, Cotter AC, Hamilton BB, Fiedler RC. Functional assessment scales: a study of persons after stroke. Arch Phys Med Rehabil. 1993 Feb;74(2):133-8.
citation: Beninato M, Gill-Body KM, Salles S, Stark PC, Black-Schaffer RM, Stein J. Determination of the minimal clinically important difference in the FIM instrument in patients with stroke. Arch Phys Med Rehabil. 2006 Jan;87(1):32-9. doi: 10.1016/j.apmr.2005.08.130.
citation: Law M, Polatajko H, Pollock N, McColl MA, Carswell A, Baptiste S. Pilot testing of the Canadian Occupational Performance Measure: clinical and measurement issues. Can J Occup Ther. 1994 Oct;61(4):191-7. doi: 10.1177/000841749406100403.