Action Observation, Imagery and Execution for Stroke Rehabilitation

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246139
• Other study ID #: 201602056A3
• Secondary ID: N201705016
• Status: Completed
• Phase: N/A
• Start date: August 23, 2017
• Est. completion date: July 31, 2020

Study information

• Verified date: June 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Action observation, imagery & execution
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
The participants will be asked to observe videos and then practice what the participants observed.
• Control treatment
The participants will receive UE training without watching videos or imagining movements/tasks.

Locations

Country	Name	City	State
Taiwan	Taipei medical university hospital	Taipei
Taiwan	Taipei Medical University Shuang Ho Hospital	Taipei
Taiwan	Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare	Taoyuan City
Taiwan	Taoyuan Chang Gung Memorial Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change scores of Modified Rankin Scale	The Modified Rankin Scale is used to assess the degree of stroke disability.	baseline, 3 weeks , 3 months
Primary	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	Change scores of Box and Block Test	The Box and Block Test is a measure of hand dexterity with satisfactory reliability and validity in patients with stroke.	baseline, 3 weeks , 3 months
Secondary	Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)	The CAHAI measures the upper-limb motor function after stroke.	baseline, 3 weeks , 3 months
Secondary	Change scores of Movement Imagery Questionnaire, revised second version	The MIQ-RS will be applied to assess patient's ability of motor imagery.	baseline, 3 weeks , 3 months
Secondary	Change scores of Functional Independence Measure	The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.	baseline, 3 weeks , 3 months
Secondary	Change scores of physical intensity measured by activity monitors	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.	baseline, 3 weeks , 3 months
Secondary	Change scores of energy expenditure measured by activity monitors	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.	baseline, 3 weeks , 3 months
Secondary	Change scores of Stroke Impact Scale (SIS) Version 3.0	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.	baseline, 3 weeks , 3 months
Secondary	Magnetoencephalography (MEG)	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).	baseline, 3 weeks