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Completed

NCT Number: NCT05580744

Augmented-reality Based Mirror Therapy in Stroke Rehabilitation

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Mirror Movement Therapy Nervous System Diseases Rehabilitation Technology Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng-Kung University Hospital

Tainan, Taiwan, 704

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Traditional occupational therapy

Other

Motor training targeted to goals that are relevant to the functional needs of the patient

Mirror therapy using a mirror box

Other

Mirror therapy using a mirror box

Augmented reality-based mirror therapy

Other

Augmented reality-based mirror therapy

Primary outcomes

  1. Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test

    Time frame: baseline, 9 weeks and 21 weeks

    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.

Secondary outcomes

  1. Change in the result of Modified Ashworth scale (MAS)

    Time frame: baseline, 9 weeks and 21 weeks

    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.

  2. Change in the result of Box and blocks test

    Time frame: baseline, 9 weeks and 21 weeks

    The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.

  3. Change in the result of Semmes-Weinstein monofilament (SWM) test

    Time frame: baseline, 9 weeks and 21 weeks

    The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.

  4. Change in the result of Motor Activity Log

    Time frame: baseline, 9 weeks and 21 weeks

    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.

Other outcomes

  1. changes in oxygenated (HbO) and deoxygenated (Hb) hemoglobin concentrations using near infrared spectroscopy (NIRS)

    Time frame: baseline, 9 weeks and 21 weeks

    To investigate the activation of specific brain regions

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 14, 2022
Registry last updated
Dec 16, 2024

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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