NCT03246139

Brief Summary

The specific study aims will be:

  1. 1.To investigate the short- and long-term treatment effects of action observation, imagery, and execution therapy (AOIE) compared with an action observation therapy (AO) group and a control treatment group as controls on different aspects of outcomes in patients with stroke.
  2. 2.To examine the neural mechanisms and changes in cortical neural activity after the interventions in stroke patients.
  3. 3.To examine the correlations between AOIE-induced brain activation changes and the clinical efficacy of AOIE.
  4. 4.To identify who are the possible good responders to the therapy based on baseline motor function and motor imagery ability of the participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable stroke

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

August 23, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

January 27, 2021

Status Verified

June 1, 2020

Enrollment Period

2.9 years

First QC Date

August 3, 2017

Last Update Submit

January 25, 2021

Conditions

Stroke

Keywords

strokeneurorehabilitationmirror neuron systemaction observationmotor imageryMEG

Outcome Measures

Primary Outcomes (2)

  • Change scores of Modified Rankin Scale

    The Modified Rankin Scale is used to assess the degree of stroke disability.

    baseline, 3 weeks , 3 months

  • Change scores of Fugl-Meyer Assessment

    Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.

    baseline, 3 weeks , 3 months

Secondary Outcomes (8)

  • Change scores of Box and Block Test

    baseline, 3 weeks , 3 months

  • Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)

    baseline, 3 weeks , 3 months

  • Change scores of Movement Imagery Questionnaire, revised second version

    baseline, 3 weeks , 3 months

  • Change scores of Functional Independence Measure

    baseline, 3 weeks , 3 months

  • Change scores of physical intensity measured by activity monitors

    baseline, 3 weeks , 3 months

  • +3 more secondary outcomes

Study Arms (3)

Action observation, imagery & execution

EXPERIMENTAL
Behavioral: Action observation, imagery & execution

Action observation

ACTIVE COMPARATOR
Behavioral: Action observation

Control treatment

ACTIVE COMPARATOR
Behavioral: Control treatment

Interventions

Action observation, imagery & executionBEHAVIORAL

The participants will be asked to observe movements through a video clip, practice motor imagery, and executing the movements that the participants observed.

Action observation, imagery & execution
Action observationBEHAVIORAL

The participants will be asked to observe videos and then practice what the participants observed.

Action observation
Control treatmentBEHAVIORAL

The participants will receive UE training without watching videos or imagining movements/tasks.

Control treatment

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed as having a unilateral stroke;
  • to 12 months after stroke onset
  • from 20 to 80 years of age
  • a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
  • able to follow the study instructions
  • capable of participating in therapy and assessment sessions.

You may not qualify if:

  • patients with global or receptive aphasia,
  • severe neglect
  • major medical problems, or comorbidities that influenced UE usage or caused severe pain
  • Additionally, if patients have no metal implants, no head traumas or neurosurgical operations, and can perform MEG motor tasks, the participants can additionally participate in the MEG assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Taipei medical university hospital

Taipei, 110, Taiwan

Location

Taipei Medical University Shuang Ho Hospital

Taipei, 23561, Taiwan

Location

Taoyuan Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

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

Taoyuan, 3351, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yu-Wei Hsieh, PhD

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

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 11, 2017

Study Start

August 23, 2017

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

January 27, 2021

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(4)