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NCT Number: NCT07666308

Virtual Reality-Based Mirror Therapy and FES-Cycling in Stroke Rehabilitation

This randomized controlled, assessor-blinded study aimed to compare the effects of virtual reality-based mirror therapy (VRBMT) and functional electrical stimulation-assisted cycling (FES-cycling) when combined with conventional rehabilitation on upper extremity recovery in patients with stroke.

Participants with first-ever stroke, unilateral hemiplegia, and upper extremity impairment within six months after stroke onset were randomly assigned to one of three groups: conventional rehabilitation alone, conventional rehabilitation plus VRBMT, or conventional rehabilitation plus FES-cycling.

All participants received a four-week rehabilitation program. Upper extremity motor function, functional independence, use of the affected upper extremity in daily activities, and quality of life were assessed before and after the intervention.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Extremity Impairments Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

Stroke frequently results in upper extremity motor impairment, leading to limitations in activities of daily living and reduced quality of life. Although conventional rehabilitation is the standard approach for improving motor recovery after stroke, technology-assisted rehabilitation methods have been developed to enhance neuroplasticity and functional outcomes.

Virtual reality-based mirror therapy provides visual feedback and aims to stimulate motor relearning mechanisms, whereas functional electrical stimulation-assisted cycling combines repetitive movement with electrically induced muscle activation to support motor recovery.

This randomized controlled, assessor-blinded study was designed to compare the additional effects of these two technology-assisted rehabilitation approaches when combined with conventional rehabilitation in patients with post-stroke upper extremity impairment.

Participants were randomly assigned to three parallel treatment groups. Clinical assessments were performed before and after completion of the rehabilitation program by an assessor blinded to group allocation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age older than 18 years
  • First-ever stroke
  • Unilateral hemiplegia
  • Time since stroke onset ≤6 months
  • Upper extremity Brunnstrom recovery stage between 1 and 4
  • Modified Ashworth Scale score <3 in the affected upper extremity
  • Ability to maintain sufficient sitting balance

Exclusion criteria

  • Visual impairment
  • Contraindication to electrical stimulation, including cardiac pacemaker implantation
  • Cognitive impairment (Mini-Mental State Examination score <25)
  • Severe aphasia preventing completion of clinical assessments
  • Presence of additional neurological disorders, including Parkinson's disease, Alzheimer's disease, multiple sclerosis, neuromuscular junction disorders, motor neuron disease, or peripheral nerve lesions
  • Neglect syndrome
  • Orthopedic conditions affecting upper extremity function, including amputation or joint contracture
  • Severe cardiac disease
  • Uncontrolled hypertension
  • Epilepsy
  • Psychiatric disorders such as schizophrenia or bipolar disorder
  • Pregnancy or suspected pregnancy
  • Acute deep vein thrombosis or thrombophlebitis
  • Local infection at the treatment site

Treatment and study plan

conventional rehabilitation

Other

A conventional rehabilitation program including neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training.

Virtual Reality-Based Mirror Therapy

Device

Virtual reality-based mirror therapy was performed using the Neuroforma system. The intervention provided visual feedback to create an illusion of movement of the paretic upper extremity and aimed to support motor relearning.

Functional Electrical Stimulation-Assisted Cycling

Device

Functional electrical stimulation-assisted cycling was performed using the RT-300 system. Electrical stimulation was applied to targeted upper extremity muscles during cycling movements to facilitate repetitive motor activity.

Primary outcomes

  1. Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment

    Time frame: Baseline and 4 weeks

    Upper extremity motor function was evaluated using the upper extremity section of the Fugl-Meyer Assessment (FMA-UE). The FMA-UE assesses motor impairment of the affected upper extremity, with total scores ranging from 0 to 66. Higher scores indicate better upper extremity motor function. Change from baseline to the post-treatment assessment was calculated as the post-treatment score minus the baseline score.

Secondary outcomes

  1. Change in Motor Recovery Assessed by the Brunnstrom Recovery Stages

    Time frame: Baseline and 4 weeks

    Motor recovery was assessed using the Brunnstrom Recovery Stages. The upper extremity and hand stages were evaluated separately. Scores range from stage 1 to stage 6, with higher stages indicating better motor recovery.

  2. Change in Functional Independence Assessed by the Functional Independence Measure

    Time frame: Baseline and 4 weeks

    Functional independence was assessed using the Functional Independence Measure (FIM). The scale evaluates motor and cognitive aspects of daily functioning. Total scores range from 18 to 126, with higher scores indicating greater functional independence.

  3. Change in Upper Extremity Use in Daily Activities Assessed by the Motor Activity Index-28

    Time frame: Baseline and 4 weeks

    Functional use of the affected upper extremity during activities of daily living was assessed using the Motor Activity Index-28 (MAI-28). Total scores range from 0 to 28, with higher scores indicating better use of the affected upper extremity.

  4. Change in Quality of Life Assessed by the Short Form-36 Health Survey

    Time frame: Baseline and 4 weeks

    Health-related quality of life was assessed using the Short Form-36 Health Survey (SF-36), which includes eight domains evaluating physical and mental health. Each domain score ranges from 0 to 100, with higher scores indicating better quality of life.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of Virtual Reality-Based Mirror Therapy and Functional Electrical Stimulation-Assisted Cycling for Upper Extremity Rehabilitation After Stroke: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 24, 2026
Registry last updated
Jun 26, 2026

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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