https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2205-z
- Tsai-yu Shih,
- Ching-yi Wu,
- Keh-chung Lin,
- Chia-hsiung Cheng,
- Yu-wei HsiehEmail author,
- Chia-ling Chen,
- Chih-jou Lai and
- Chih-chi Chen
Received: 15 December 2016
Accepted: 18 September 2017
Published: 4 October 2017
Abstract
Background
Loss of upper-extremity motor
function is one of the most debilitating deficits following stroke. Two
promising treatment approaches, action observation therapy (AOT) and
mirror therapy (MT), aim to enhance motor learning and promote neural
reorganization in patients through different afferent inputs and
patterns of visual feedback. Both approaches involve different patterns
of motor observation, imitation, and execution but share some similar
neural bases of the mirror neuron system. AOT and MT used in stroke
rehabilitation may confer differential benefits and neural activities
that remain to be determined. This clinical trial aims to investigate
and compare treatment effects and neural activity changes of AOT and MT
with those of the control intervention in patients with subacute stroke.
Methods/design
An estimated total of 90
patients with subacute stroke will be recruited for this study. All
participants will be randomly assigned to receive AOT, MT, or control
intervention for a 3-week training period (15 sessions). Outcome
measurements will be taken at baseline, immediately after treatment, and
at the 3-month follow-up. For the magnetoencephalography (MEG) study,
we anticipate that we will recruit 12 to 15 patients per group. The
primary outcome will be the Fugl-Meyer Assessment score. Secondary
outcomes will include the modified Rankin Scale, the Box and Block Test,
the ABILHAND questionnaire, the Questionnaire Upon Mental Imagery, the
Functional Independence Measure, activity monitors, the Stroke Impact
Scale version 3.0, and MEG signals.
Discussion
This clinical trial will
provide scientific evidence of treatment effects on motor, functional
outcomes, and neural activity mechanisms after AOT and MT in patients
with subacute stroke. Further application and use of AOT and MT may
include telerehabilitation or home-based rehabilitation through
web-based or video teaching.
Trial registration
ClinicalTrials.gov, ID: NCT02871700. Registered on 1 August 2016.
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