Mirror Therapy After Stroke: A Dosing Study

NCT02778087 | Terminated

• 1 other identifier: AAAQ2004
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

It has been suggested that augmenting repetitive task practice with the use of box (mirror) therapy (BT) can enhance the benefits of task practice and may provide stroke survivors an opportunity to engage in self-directed practice outside of normally scheduled therapy sessions. However, the dosage of BT to be used in clinical practice is unclear. In order for practitioners to begin integrating BT into clinical practice situations more information is needed to determine what defines a therapeutic dose. The aim of this study is to differentiate between two dosages of self-directed BT added to treatment as usual for decreasing arm and hand motor impairments, improving activity level, and increasing self-directed participation after stroke. Forty-five subjects from the Stroke Rehabilitation Unit at Helen Hayes Hospital (HHH) will be randomly assigned into three groups: treatment as usual plus 30 minute dosage of self-directed BT 5x/week; treatment as usual plus 60 minute dosage of self-directed BT 5x/week; treatment as usual plus 30 minutes of self-directed sham BT 5x/week.

Conditions

Stroke

Keywords

motor recovery; mirror therapy; upper extremity

Outcome Measures

Primary Outcomes (1)

• Score on Action Research Arm Test:

  This test examines hand and arm motor function. It consists of 19 movement tasks divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale, ranging from 3 (performs test normally) to 0 (can perform no part of test). Totaled scores range from 0-57 with higher scores indicating higher functioning. Normative data for stroke has been published for this tool (Beebe \& Lang, 2009; van der Lee et al., 2001). This tool has been found to be a valid measure (Platz et al., 2005; van der Lee et al., 2001). This test has excellent test-retest reliability (Platz et al., 2005), as well as inter-rater reliability (Nijland et al., 2010). Minimally clinically important difference (MCID) for this test has been established for both acute (Lang et al., 2008) and chronic stroke survivors (van der Lee et al., 2001).

  pre and post intervention up to 12 months

Secondary Outcomes (3)

• Score on Stroke Impact Scale

  pre and post intervention up to 12 months

• Score on Functional Independence Measure

  pre and post intervention up to 12 months

• Score on Fugl-Meyer Assessment of Motor Recovery after Stroke (arm/hand section)

  pre and post intervention up to 12 months

Study Arms (3)

TAU plus 30 minutes of BT.

EXPERIMENTAL

Intervention: Subjects randomized to the 30 minute intervention will perform the above 15 minute Mirror Box Therapy intervention independently two times per day in addition to their treatment as usual.

Behavioral: Mirror Box Therapy

TAU plus 60 minute of BT.

EXPERIMENTAL

Intervention: Subjects randomized to the 60 minute intervention will perform the above 15 minute Mirror Box Therapy intervention independently four times per day in addition to their treatment as usual.

Behavioral: Mirror Box Therapy

TAU plus 30 minutes of sham BT.

SHAM COMPARATOR

Intervention: Subjects randomized to the control (sham) group will perform the above Sham Mirror Box Therapy intervention independently two times per day. The control group will be using a mirror box with an opaque surface as opposed to a reflective mirror.

Behavioral: Sham Mirror Box Therapy

Interventions

Mirror Box Therapy BEHAVIORAL

The BT intervention will be delivered in 15 minute increments via a self-directed program. The subject will sit comfortably at a table or desk in front of a box, which will be positioned in the mid-sagittal plane. The subject will place his or her affected arm inside the box so that it is out of view. The subject will then place his or her unaffected arm on the table and will be instructed to focus their attention on the mirror reflection of the unaffected arm throughout the intervention. The 15 minute intervention will consist of the following movements/tasks: active range of motion (AROM), functional tasks with objects, and object manipulation.

TAU plus 30 minutes of BT.; TAU plus 60 minute of BT.

Sham Mirror Box Therapy BEHAVIORAL

The BT intervention will be delivered in 15 minute increments via a self-directed program. The subject will sit comfortably at a table or desk in front of a box, which will be positioned in the mid-sagittal plane. The subject will place his or her affected arm inside the box so that it is out of view. The subject will then place his or her unaffected arm on the table and will be instructed to focus their attention on an opaque mirror throughout the intervention. The 15 minute intervention will consist of the following movements/tasks: AROM, functional tasks with objects, and object manipulation.

TAU plus 30 minutes of sham BT.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults status post ischemic or hemorrhagic stroke between the ages 18-85, receiving inpatient rehabilitation
• Using the impaired arm, ability to lift and release a wash cloth off a table with any means of prehension in either the sitting or standing positions
• A score \> 21/30 on the Mini-Mental State Exam
• Ability to consent.

You may not qualify if:

• Serious visual or visual-perceptual deficits, neuropsychological impairments, or orthopedic conditions that would prevent participation in the BT protocol as determined by the treatment team
• Involvement in another study protocol related to motor function after stroke
• Anticipated length of stay less than two weeks
• More than six months post stroke

Sponsors & Collaborators

• Columbia University: lead
• Helen Hayes Hospital: collaborator

Study Sites (1)

Helen Hayes Hospital (Stroke Unit)

West Haverstraw, New York, 10993, United States

Location

Related Publications (5)

• Nilsen DM, Gillen G, Geller D, Hreha K, Osei E, Saleem GT. Effectiveness of interventions to improve occupational performance of people with motor impairments after stroke: an evidence-based review. Am J Occup Ther. 2015 Jan-Feb;69(1):6901180030p1-9. doi: 10.5014/ajot.2015.011965.

  PMID: 25553742 BACKGROUND

• Nilsen DM, DiRusso T. Using mirror therapy in the home environment: a case report. Am J Occup Ther. 2014 May-Jun;68(3):e84-9. doi: 10.5014/ajot.2014.010389.

  PMID: 24797202 BACKGROUND

• Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Stroke. 2013 Jan;44(1):e1-2. doi: 10.1161/strokeaha.112.673087.

  PMID: 23390640 BACKGROUND

• Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD008449. doi: 10.1002/14651858.CD008449.pub2.

  PMID: 22419334 BACKGROUND

• Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.

  PMID: 25520374 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

• Glen Gillen, EdD, OTR

  Columbia University

  PRINCIPAL INVESTIGATOR

• Steven W. Lichtman, EdD

  Helen Hayes Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Rehabilitation and Regenerative Medicine

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: January 1, 2017
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2018
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)