NCT03418883

Brief Summary

This study evaluates the effects of mirror therapy on upper-limb motor impairment in stroke patients early after their cerebrovascular accident. In recent years mirror therapy has been used in stroke rehabilitation, both to ease motor (e.g., upper limb impairment) and cognitive (e.g., spatial neglect) recovery. To note, mirror therapy is a simple and inexpensive treatment that patients can practice independently and with no significant side effects. However, a recent review concluded that the currently evidence available is not enough to determine about the actual effectiveness of mirror therapy in stroke survivors. Moreover, at our knowledge, the majority of studies recruited chronic stroke patients while only a few trials recruited patients within few weeks after stroke. Therefore, further research is encouraged particularly early after stroke. In mirror therapy patients exercise their sound hand while it is reflected by a mirror placed at right angle to the patient's trunk. With this gambit, patients see two hands moving: their sound hand (i.e., the hand that is voluntarily moved) and the "avatar" of their impaired hand (i.e., the sound hand reflection in the mirror). In this assessor-blinded, randomized controlled trial half of participants receive mirror therapy .The other half receive sham therapy, in which the mirror is flipped so that the opaque surface face the sound arm. Mirror therapy and sham therapy are added to conventional rehabilitation. In the current work, we investigate the efficacy of mirror therapy on upper-limb recovery in early post-stroke patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

January 16, 2018

Last Update Submit

January 25, 2018

Conditions

Stroke, Acute

Keywords

Strokerehabilitationmirror therapyupper limb

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer (upper limb section)

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation and joint functioning in patients with post-stroke hemiplegia.

    Change from baseline FMA at six week.

Secondary Outcomes (2)

  • Action Research Arm Test

    Change from baseline ARAT at six week.

  • Functional Independence Measure

    Change from baseline FIM at six week.

Study Arms (2)

Mirror therapy

EXPERIMENTAL

Patient is sitting on a conventional chair and placed her/his forearms on a table. A mirror (45 cm × 40 cm) is positioned between the two arms, at right angle with the patient's trunk. The reflective surface is oriented so that the participant could easily see the mirror image of his/her sound arm. Patient practises his/her sound arm with exercises, ranging from the simple elbow flexion-extension to complex tasks.

Other: Mirror therapy

Sham therapy

SHAM COMPARATOR

Patient is sitting on a conventional chair and placed her/his forearms on a table. A box (45 cm × 40 cm) is positioned between the two arms, at right angle with the patient's trunk. The opaque surface replaces the mirror reflecting surface. Patient practises his/her sound arm with exercises,ranging from the simple elbow flexion-extension to complex tasks.

Other: Mirror therapy

Interventions

Mirror therapyOTHER
Mirror therapySham therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first ischemic or hemorrhagic stroke causing right or left hemiplegia or hemiparesis;
  • enrolling in the trial within four weeks from the stroke;
  • Mini Mental State Examination (MMSE) score ≥ 24, in order to exclude patients with significant cognitive decline;
  • Token Test score \< 40, in order to exclude patients with severe verbal comprehension deficits.

You may not qualify if:

  • significant visual impairment despite glasses,
  • cognitive deficits that could prevent patients from understanding the therapist instructions,
  • an additional neurological or orthopedic disease (e.g., Parkinson's disease, limb amputation) known to cause a motor impairment for itself.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Ramachandran VS, Altschuler EL. The use of visual feedback, in particular mirror visual feedback, in restoring brain function. Brain. 2009 Jul;132(Pt 7):1693-710. doi: 10.1093/brain/awp135. Epub 2009 Jun 8.

    PMID: 19506071BACKGROUND

  • 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: 22419334BACKGROUND

  • Chow S-C, Wang H, Shao J. Sample size calculations in clinical research. CRC press; 2007.ISBN 9781584889823

    BACKGROUND

  • R Core Team. R: A Language and Environment for Statistical Computing. Vienna, Austria; 2017.ISBN: 3-900051-07-0.

    BACKGROUND

  • Wickham H. ggplot2: Elegant Graphics for Data Analysis. Springer-Verlag New York; 2009. ISBN 978-0-387-98141-3

    BACKGROUND

  • Wilke CO. cowplot: Streamlined Plot Theme and Plot Annotations for "ggplot2." 2016.

    BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Massimo Corbo, MD

    Casa di Cura Privata Policlinico (CCPP)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2018

First Posted

February 1, 2018

Study Start

February 5, 2014

Primary Completion

July 15, 2016

Study Completion

September 22, 2016

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share