Augmented-reality Based Mirror Therapy in Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Effects of Augmented-reality Based Mirror Therapy on Sensorimotor Function of Upper Extremity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580744
• Other study ID #: B-ER-111-246
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: National Cheng-Kung University Hospital
• Contact: Hsiu-Yun Hsu, Ph.D
• Phone: 886-6-2353535
• Email: hyhsu[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the proposed study, the investigators assumed that mirror therapy combined with augmented reality technology will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either augmented reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of stroke with unilateral side involved;

• A score of Mini-mental state examination greater than 24 for proving higher mental function

• Time of onset > 6 months before treatment begins; and

• Premorbid right-handedness.

Exclusion Criteria:

• Severe vision impairment;

• Major cognitive-perceptual deficit;

• Other brain disease.

Related Conditions & MeSH terms

• Rehabilitation
• Stroke
• Technology

Intervention

Other:
• Traditional occupational therapy
Motor training targeted to goals that are relevant to the functional needs of the patient
• Mirror therapy using a mirror box
Mirror therapy using a mirror box
• Augmented reality-based mirror therapy
Augmented reality-based mirror therapy

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	changes in oxygenated (HbO) and deoxygenated (Hb) hemoglobin concentrations using near infrared spectroscopy (NIRS)	To investigate the activation of specific brain regions	baseline, 9 weeks and 21 weeks
Primary	Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test	Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.	baseline, 9 weeks and 21 weeks
Secondary	Change in the result of Modified Ashworth scale (MAS)	Muscle tone is defined by the resistance of a muscle being stretched without resistance. The MAS scores were distributed across the entire scale, ranging from 0 to 4, that is convenient for the clinician use. The grading of the scale is described as below: 0) no increase in muscle tone; 1) minimal resistance at the end of the range of motion; 1+) slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the reminder (less than half) of the ROM; 2) more marked increase in tone but only after part is easily flexed; 3) considerable increase in tone; and 4) passive movement is difficult and affected part is rigid in flexion or extension.	baseline, 9 weeks and 21 weeks
Secondary	Change in the result of Box and blocks test	The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.	baseline, 9 weeks and 21 weeks
Secondary	Change in the result of Semmes-Weinstein monofilament (SWM) test	The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.	baseline, 9 weeks and 21 weeks
Secondary	Change in the result of Motor Activity Log	Semi-structured interview examine how much and how well the subject uses their more-affected arm for 30 ADLs. Score range from 0-5. Higher values represent a better outcome.	baseline, 9 weeks and 21 weeks