Mirror Box Therapy for Upper Limb Function With Stroke

NCT02276729 | Completed

• 1 other identifier: 165094
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident (CVA); Stroke

Keywords

Upper limb; Rehabilitation; Occupational Therapy; Mirror Box Therapy

Outcome Measures

Primary Outcomes (3)

• Change in Functional Independence Measure v4 at 6 weeks

  The FIM/FAM (Version 4) is an 18 item measure of 6 areas of function (self-care; sphincter control; mobility; locomotion; communication and social cognition) grouped into two domains of motor items and cognitive items. Each item is scored on a 7-point likert scale and the score indicates the amount of assistance required to perform each item (ranging from 1 representing total assistance in all areas to 7 representing total independence in all areas), and has been widely used post-stroke18.

  Baseline and 6 weeks.

• Change in Functional Independence Measure v4 at 3 months post-discharge

  The FIM/FAM (Version 4) is an 18 item measure of 6 areas of function (self-care; sphincter control; mobility; locomotion; communication and social cognition) grouped into two domains of motor items and cognitive items. Each item is scored on a 7-point likert scale and the score indicates the amount of assistance required to perform each item (ranging from 1 representing total assistance in all areas to 7 representing total independence in all areas), and has been widely used post-stroke18.

  Baseline and 3 months

• Change in Functional Independence Measure v4 at 6 months post-discharge

  The FIM/FAM (Version 4) is an 18 item measure of 6 areas of function (self-care; sphincter control; mobility; locomotion; communication and social cognition) grouped into two domains of motor items and cognitive items. Each item is scored on a 7-point likert scale and the score indicates the amount of assistance required to perform each item (ranging from 1 representing total assistance in all areas to 7 representing total independence in all areas), and has been widely used post-stroke18.

  Baseline and 6 months

Secondary Outcomes (8)

• Change in Graded Wolf Motor Function Test (gWMFT) at 6 weeks

  Baseline and 6 weeks.

• Change in Graded Wolf Motor Function Test (gWMFT) at 3 months post-discharge

  Baseline and 3 months.

• Change in Graded Wolf Motor Function Test (gWMFT) at 6 months post-discharge

  Baseline and 6 months.

• Change in EQ-5D-5L15 at 6 weeks

  Baseline and 6 weeks.

• Change in EQ-5D-5L15 at 3 months post-discharge

  Baseline and 3 months.

Study Arms (2)

Mirror Box Treatment Group

EXPERIMENTAL

Participants in the intervention group will be required to perform two 20 minute sessions of Mirror Box Therapy, five days/week for the duration of their in-patient stay carried out under the direction of members of the OT stroke team as well as receiving 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.

Other: Mirror Box Therapy

Conventional Therapy Control Group

NO INTERVENTION

Participants in the control group 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.

Interventions

Mirror Box Therapy OTHER

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. It is postulated that mirror visual feedback can stimulate neural recovery in the brain 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 to improve upper limb function.

Mirror Box Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Alison Porter-Armstrong: lead
• Northern Health and Social Care Trust: collaborator

Study Sites (1)

Whiteabbey Hospital, Northern Health and Social Care Trust

Belfast, Co Antrim, BT35 9RH, United Kingdom

Location

Related Publications (16)

• Scarborough P, Peto V, Bhatnagar P, et al (2009) Stroke Statistics. Dept of Public Health, University of Oxford.

  BACKGROUND

• 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.

  PMID: 15742251 BACKGROUND

• 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

  BACKGROUND

• Intercollegiate Stroke Working Party (ISWP) (2008), National Clinical Guideline for Stroke. 3rd edition. London, UK: Royal College Physicians

  BACKGROUND

• Intercollegiate Stroke Working Party (ISWP) (2012). National Clinical Guideline for Stroke. 4th edition. London, UK: Royal College Physicians

  BACKGROUND

• 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.

  PMID: 10376620 BACKGROUND

• 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.

  PMID: 18295613 BACKGROUND

• 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.

  PMID: 8637922 BACKGROUND

• 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.

  PMID: 12881842 BACKGROUND

• 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.

  PMID: 16224078 BACKGROUND

• 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.

  PMID: 19074686 BACKGROUND

• 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.

  PMID: 11387578 BACKGROUND

• 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.

  PMID: 19398398 BACKGROUND

• 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.

  PMID: 8431095 BACKGROUND

• 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.

  PMID: 16401435 BACKGROUND

• 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.

  PMID: 10137673 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alison Porter-Armstrong, DPhil

  University of Ulster, Northern Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer in Rehabilitation Sciences

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 28, 2014
• Study Start: April 1, 2015
• Primary Completion: May 31, 2018
• Study Completion: October 11, 2018
• Last Updated: December 14, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)