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Completed

NCT Number: NCT03246139

Action Observation, Imagery and Execution for Stroke Rehabilitation

The specific study aims will be:

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. To examine the neural mechanisms and changes in cortical neural activity after the interventions in stroke patients. 3. To examine the correlations between AOIE-induced brain activation changes and the clinical efficacy of AOIE. 4. To identify who are the possible good responders to the therapy based on baseline motor function and motor imagery ability of the participants.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Shuang Ho Hospital, Taipei, Taiwan

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About this study

The investigators propose a 3-year randomized controlled trial to (1) investigate the short- and long-term treatment efficacy of AOIE, action observation alone, versus control treatment on clinical outcomes of patients with subacute stroke, (2) examine the neural mechanisms and activation changes after the 3 interventions by using an advanced brain imaging technique, magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes, and (4) identify who are the good responders to the AOIE therapy. An estimated total of 96 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive 1 of the 3 interventions for 3 weeks (a total of 15 sessions). Clinical outcome measures will be conducted at baseline, immediately after treatment (3 weeks), and at 3 months follow-up. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks). For the MEG study, The investigators anticipate to enroll 12 to 15 patients in each group to complete neuroimaging evaluation because of the specific eligibility criteria and high costs of MEG. The patients can still participate in the study, receiving rehabilitation therapy and clinical evaluations, even if the participants will not be included in the MEG study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed as having a unilateral stroke;
  • 1 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.

Exclusion criteria

  • 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.

Treatment and study plan

Action observation, imagery & execution

Behavioral

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

Behavioral

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

Control treatment

Behavioral

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

Primary outcomes

  1. Change scores of Modified Rankin Scale

    Time frame: baseline, 3 weeks , 3 months

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

  2. Change scores of Fugl-Meyer Assessment

    Time frame: baseline, 3 weeks , 3 months

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

Secondary outcomes

  1. Change scores of Box and Block Test

    Time frame: baseline, 3 weeks , 3 months

    The Box and Block Test is a measure of hand dexterity with satisfactory reliability and validity in patients with stroke.

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

    Time frame: baseline, 3 weeks , 3 months

    The CAHAI measures the upper-limb motor function after stroke.

  3. Change scores of Movement Imagery Questionnaire, revised second version

    Time frame: baseline, 3 weeks , 3 months

    The MIQ-RS will be applied to assess patient's ability of motor imagery.

  4. Change scores of Functional Independence Measure

    Time frame: baseline, 3 weeks , 3 months

    The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.

  5. Change scores of physical intensity measured by activity monitors

    Time frame: baseline, 3 weeks , 3 months

    The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of average intensity of physical activity (counts/minute) will be reported.

  6. Change scores of energy expenditure measured by activity monitors

    Time frame: baseline, 3 weeks , 3 months

    The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of energy expenditure(Kcal) will be reported.

  7. Change scores of Stroke Impact Scale (SIS) Version 3.0

    Time frame: baseline, 3 weeks , 3 months

    The Stroke Impact Scale Version 3.0 is a patient-reported outcome to evaluate function, participation, and health-related quality of life of stroke survivors with sound psychometric properties.

  8. Magnetoencephalography (MEG)

    Time frame: baseline, 3 weeks

    Magnetoencephalography (MEG) can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks).

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Action Observation, Imagery and Execution as a New Intervention Strategy for Stroke Rehabilitation: Short- and Long-term Treatment Effects and Neural Mechanism

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2017
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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