ClinicalTrials.gov
ClinicalTrials.gov Menu

Mirror Box Therapy for Upper Limb Function With Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02276729
Recruitment Status : Active, not recruiting
First Posted : October 28, 2014
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
Northern Health and Social Care Trust
Information provided by (Responsible Party):
Dr Alison Porter-Armstrong, University of Ulster

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident (CVA) Stroke Other: Mirror Box Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Pilot Randomized Controlled Trial (RCT) of Mirror Box Therapy in Upper Limb Rehabilitation With Sub-acute Stroke Patients
Study Start Date : April 2015
Estimated Primary Completion Date : January 12, 2018
Estimated Study Completion Date : January 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Mirror Box Treatment Group
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
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.

No Intervention: Conventional Therapy Control Group
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.



Primary Outcome Measures :
  1. Change in Functional Independence Measure v4 at 6 weeks [ Time Frame: Baseline and 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.

  2. Change in Functional Independence Measure v4 at 3 months post-discharge [ Time Frame: Baseline and 3 months ]
    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.

  3. Change in Functional Independence Measure v4 at 6 months post-discharge [ Time Frame: Baseline and 6 months ]
    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.


Secondary Outcome Measures :
  1. Change in Graded Wolf Motor Function Test (gWMFT) at 6 weeks [ Time Frame: Baseline and 6 weeks. ]
    The gWMFT is a 15-item standardised measure which determines the motor ability of participants by recording functional movement time (0- 120 seconds per item, total = mean of 15 items, maximum score= 120 seconds) and quality of movement (0-7 Likert scale per item with 0= no movement, to 7 = normal movement, total = mean of 15 items, maximum score= 7). This graded version has two levels of each task which can be chosen depending on the participants' general functioning level. The graded version was developed from the original WMFT which has shown to have good reliability and validity. Despite being named a motor assessment, this assessment includes assessment of the upper limb using functional activities and, as such, is considered of relevance to OT outcomes. This outcome measure has also been used by other investigators in previous studies with a stroke cohort.

  2. Change in Graded Wolf Motor Function Test (gWMFT) at 3 months post-discharge [ Time Frame: Baseline and 3 months. ]
    The gWMFT is a 15-item standardised measure which determines the motor ability of participants by recording functional movement time (0- 120 seconds per item, total = mean of 15 items, maximum score= 120 seconds) and quality of movement (0-7 Likert scale per item with 0= no movement, to 7 = normal movement, total = mean of 15 items, maximum score= 7). This graded version has two levels of each task which can be chosen depending on the participants' general functioning level. The graded version was developed from the original WMFT which has shown to have good reliability and validity. Despite being named a motor assessment, this assessment includes assessment of the upper limb using functional activities and, as such, is considered of relevance to OT outcomes. This outcome measure has also been used by other investigators in previous studies with a stroke cohort.

  3. Change in Graded Wolf Motor Function Test (gWMFT) at 6 months post-discharge [ Time Frame: Baseline and 6 months. ]
    The gWMFT is a 15-item standardised measure which determines the motor ability of participants by recording functional movement time (0- 120 seconds per item, total = mean of 15 items, maximum score= 120 seconds) and quality of movement (0-7 Likert scale per item with 0= no movement, to 7 = normal movement, total = mean of 15 items, maximum score= 7). This graded version has two levels of each task which can be chosen depending on the participants' general functioning level. The graded version was developed from the original WMFT which has shown to have good reliability and validity. Despite being named a motor assessment, this assessment includes assessment of the upper limb using functional activities and, as such, is considered of relevance to OT outcomes. This outcome measure has also been used by other investigators in previous studies with a stroke cohort.

  4. Change in EQ-5D-5L15 at 6 weeks [ Time Frame: Baseline and 6 weeks. ]
    The EQ-5D-5L is a widely-used standardized 2 page instrument for use as a measure of health outcome. It is applicable to a wide range of health conditions and treatments and provides a simple descriptive profile of 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) across 5 levels ranging from no problems to extreme problems, and a visual analogue scale of the respondent's self- rated health ranging from 'best imaginable health state' to 'worst imaginable health state'.

  5. Change in EQ-5D-5L15 at 3 months post-discharge [ Time Frame: Baseline and 3 months. ]
    The EQ-5D-5L is a widely-used standardized 2 page instrument for use as a measure of health outcome. It is applicable to a wide range of health conditions and treatments and provides a simple descriptive profile of 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) across 5 levels ranging from no problems to extreme problems, and a visual analogue scale of the respondent's self- rated health ranging from 'best imaginable health state' to 'worst imaginable health state'.

  6. Change in EQ-5D-5L15 at 6 months post-discharge [ Time Frame: Baseline and 6 months. ]
    The EQ-5D-5L is a widely-used standardized 2 page instrument for use as a measure of health outcome. It is applicable to a wide range of health conditions and treatments and provides a simple descriptive profile of 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) across 5 levels ranging from no problems to extreme problems, and a visual analogue scale of the respondent's self- rated health ranging from 'best imaginable health state' to 'worst imaginable health state'.

  7. Change in Canadian Occupational Performance Measure (COPM) at 3 months post-discharge [ Time Frame: Baseline and 3 months. ]
    The COPM is a standardized outcome measure to detect change in a client's self-perception of occupational performance over time. It uses a semi-structured interview format and structured scoring method to detect change scores between assessment and reassessment in everyday occupational activities.

  8. Change in Canadian Occupational Performance Measure (COPM) at 6 months post-discharge [ Time Frame: Baseline and 6 months. ]
    The COPM is a standardized outcome measure to detect change in a client's self-perception of occupational performance over time. It uses a semi-structured interview format and structured scoring method to detect change scores between assessment and reassessment in everyday occupational activities.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276729


Locations
United Kingdom
Whiteabbey Hospital, Northern Health and Social Care Trust
Belfast, Co Antrim, United Kingdom, BT35 9RH
Sponsors and Collaborators
Dr Alison Porter-Armstrong
Northern Health and Social Care Trust
Investigators
Principal Investigator: Alison Porter-Armstrong, DPhil University of Ulster, Northern Ireland

Publications:
Scarborough P, Peto V, Bhatnagar P, et al (2009) Stroke Statistics. Dept of Public Health, University of Oxford.
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
Intercollegiate Stroke Working Party (ISWP) (2008), National Clinical Guideline for Stroke. 3rd edition. London, UK: Royal College Physicians
Intercollegiate Stroke Working Party (ISWP) (2012). National Clinical Guideline for Stroke. 4th edition. London, UK: Royal College Physicians
Law M, Baptiste S, McColl M, Carswell A, Polatajko H, Pollock N. The Canadian Occupational Performance Measures (COPM) 4th edition, Toronto: CAOT.

Responsible Party: Dr Alison Porter-Armstrong, Senior Lecturer in Rehabilitation Sciences, University of Ulster
ClinicalTrials.gov Identifier: NCT02276729     History of Changes
Other Study ID Numbers: 165094
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr Alison Porter-Armstrong, University of Ulster:
Upper limb
Rehabilitation
Occupational Therapy
Mirror Box Therapy

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases