Virtual Reality Mirror Therapy With Focused Object-Directed Attention System

NCT07525713 — Not applicable, Recruiting, 54 participants, National Cheng-Kung University Hospital

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Virtual Reality Mirror Therapy With Focused Object-Directed Attention for Neuro-Rehabilitation

RegistryNCT07525713
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment54 (Estimated)
SponsorNational Cheng-Kung University Hospital (Other)
ConditionsStroke, Rehabilitation, Virtual Reality, Mirror Movement Therapy, Attention, Task Performance
Interventionstask-oriented training (Other)
Datesstart 2026-04-20, primary completion 2027-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-04-13, last updated 2026-06-16
Locations1 site in Taiwan

Related Papers Related Patents Related Grants Related Experts
All trials for Stroke All trials for Rehabilitation All trials of task-oriented training

-Summary

In this study, the investigators hypothesized that Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA) would yield superior therapeutic effects compared to conventional Virtual Reality Mirror Therapy (VRMT) in individuals with unilateral stroke.

The aim of this study is to compare the immediate effects of a single session of VRMT, VRMTFOA, and VRMTFOA with auditory feedback on upper extremity function and brain activity in stroke patients.

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+Arms and interventions

ArmTypeInterventionsDescription
Virtual Reality Mirror Therapy GroupActive comparatorOther: task-oriented training30 minutes of Virtual Reality Mirror Therapy combined with 20 minutes of conventional task-oriented therapy.
Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA)ExperimentalOther: task-oriented training30 minutes of Virtual Reality Mirror Therapy with Focused Object-Directed Attention combined with 20 minutes of conventional task-oriented therapy.
VRMTFOA with auditory feedbackActive comparatorOther: task-oriented training30 minutes of VRMTFOA with auditory feedback combined with 20 minutes of conventional task-oriented therapy.
  • task-oriented training (Other): Virtual Reality Mirror Therapy combined with Motor training targeted to goals that are relevant to the functional needs of the patient

+Outcome measures

Primary outcomes

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

  • Change in the result of Modified Ashworth scale (MAS) [baseline, 9 weeks and 21 weeks]: Muscle tone is defined by assess muscle tone by evaluating resistance to passive stretch, reflecting the level of spasticity, with scores ranging from 0 (no increase in tone) to 4 (rigidity in flexion or extension).
  • Change in the result of Box and blocks test [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.
  • Change in the result of Semmes-Weinstein monofilament (SWM) test [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.
  • Change in the result of Motor Activity Log [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.
  • Surface electromyography (sEMG) [baseline, 9 weeks]: Change in the root mean square (RMS) of the EMG signal was computed to quantify the change of muscle activation.
  • Clinical Global Impression (CGI) scale [9 weeks]: Assess overall clinical change, rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).

+Eligibility

Sex: All, ages: 20 Years to 80 Years, accepts healthy volunteers

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;
* Premorbid right-handedness.

Exclusion Criteria:

* Severe vision impairment;
* Major cognitive-perceptual deficit;
* Other brain disease.

+Locations (1)

FacilityCityCountryStatus
National Cheng-Kung University HospitalTainan, TaiwanTaiwanRecruiting