Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke

NCT ID: NCT02871700

Last Updated: 2019-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-10-31

Brief Summary

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The specific aims of this study will be to:

1. investigate the treatment efficacy of Action observation therapy (AOT), mirror therapy (MT) versus a control intervention on motor and functional outcomes of stroke patients.
2. compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG).
3. determine the correlations between neural activation changes and clinical outcomes after AOT and MT.
4. identify who are the potential good responders to AOT and MT.

Detailed Description

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In this 3-year study project, the investigators will design a comparative, randomized controlled trial to (1) investigate the treatment efficacy of AOT, MT versus a control intervention on motor and functional outcomes of stroke patients, (2) compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes after AOT and MT, and (4) identify who are the potential good responders to AOT and MT. An estimated total of 90 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive AOT, MT, or control intervention for a 3-week training period (a total of 15 sessions). Outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up. For the MEG study, the investigators anticipate to recruit 12 to 15 patients in each group. The patients can still participate in this study to receive treatments and clinical evaluations even if they do not meet the MEG eligibility criteria or are not willing to participate in the MEG study.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Action observation therapy (AOT)

Action observation therapy (AOT)

Group Type EXPERIMENTAL

Action observation therapy

Intervention Type BEHAVIORAL

The patients were asked to observe everyday life actions of which they had motor experience or the actions belong to the motor repertoire of observers', they had better performance. The common categories of motor actions and tasks for stroke patients are selected in this study: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-extremity (UE) functional tasks practice.

Mirror therapy (MT)

Mirror therapy (MT)

Group Type EXPERIMENTAL

Mirror therapy

Intervention Type BEHAVIORAL

The MT group will receive 60 minutes of upper-limb training in a mirror box. MT treatment activities will include AROM exercises (10 to 15 minutes), reaching movement or object manipulation (15 to 20 minutes), and functional tasks practice (30 minutes) in a mirror box.

Control group

Customary bilateral UE training

Group Type ACTIVE_COMPARATOR

Customary bilateral UE training

Intervention Type BEHAVIORAL

The participants in this group will receive dose-matched customary bilateral UE training programs for 1 hour per session. The treatment protocol of control group will also include: (a) AROM exercises (10 to 15 minutes), (b) reaching movement or object manipulation (15 to 20 minutes), and (3) functional tasks practice (30 minutes).

Interventions

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Action observation therapy

The patients were asked to observe everyday life actions of which they had motor experience or the actions belong to the motor repertoire of observers', they had better performance. The common categories of motor actions and tasks for stroke patients are selected in this study: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-extremity (UE) functional tasks practice.

Intervention Type BEHAVIORAL

Mirror therapy

The MT group will receive 60 minutes of upper-limb training in a mirror box. MT treatment activities will include AROM exercises (10 to 15 minutes), reaching movement or object manipulation (15 to 20 minutes), and functional tasks practice (30 minutes) in a mirror box.

Intervention Type BEHAVIORAL

Customary bilateral UE training

The participants in this group will receive dose-matched customary bilateral UE training programs for 1 hour per session. The treatment protocol of control group will also include: (a) AROM exercises (10 to 15 minutes), (b) reaching movement or object manipulation (15 to 20 minutes), and (3) functional tasks practice (30 minutes).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. diagnosed as having a unilateral stroke
2. 1 to 6 months after stroke onset
3. from 20 to 80 years of age
4. a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
5. able to follow the study instructions (measured by the Montreal Cognitive Assessment)
6. capable of participating in therapy and assessment sessions

Exclusion Criteria

1. patients with global or receptive aphasia
2. severe neglect
3. major medical problems, or comorbidities that influenced UE usage or caused severe pain
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Wei Hsieh, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, and Healthy Aging Research Center, Chang Gung University

Locations

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Taipei Tzu Chi hospital, Buddhist Tzu Chi Medical fundation

Taipei, , Taiwan

Site Status

Cathay General Hospital (Taipei and Sijhi)

Taipei, , Taiwan

Site Status

Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare

Taoyuan District, , Taiwan

Site Status

Taoyuan Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

References

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Hsieh YW, Lin YH, Zhu JD, Wu CY, Lin YP, Chen CC. Treatment Effects of Upper Limb Action Observation Therapy and Mirror Therapy on Rehabilitation Outcomes after Subacute Stroke: A Pilot Study. Behav Neurol. 2020 Jan 2;2020:6250524. doi: 10.1155/2020/6250524. eCollection 2020.

Reference Type DERIVED
PMID: 32377266 (View on PubMed)

Shih TY, Wu CY, Lin KC, Cheng CH, Hsieh YW, Chen CL, Lai CJ, Chen CC. Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial. Trials. 2017 Oct 4;18(1):459. doi: 10.1186/s13063-017-2205-z.

Reference Type DERIVED
PMID: 28978349 (View on PubMed)

Other Identifiers

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104-9173A3

Identifier Type: -

Identifier Source: org_study_id

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