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CompletedNCT07666308Updated Jun 26, 2026

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

An interventional study of Conventional Rehabilitation and Virtual Reality-Based Mirror Therapy in Stroke, Hemiplegia and Upper Extremity Impairments, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 1 month after the study started (first participant enrolled May 2021, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Stroke
  • Hemiplegia
  • Upper Extremity Impairments

Keywords

  • Stroke rehabilitation
  • Upper extremity rehabilitation
  • Virtual reality
  • Mirror therapy
  • Functional electrical stimulation
  • FES cycling
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Conventional Rehabilitation

    Participants received a conventional rehabilitation program consisting of neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training for 40 minutes per day, five days per week, for four weeks.

    Other: Conventional Rehabilitation

  • Experimental
    Virtual Reality-Based Mirror Therapy

    Participants received conventional rehabilitation combined with virtual reality-based mirror therapy using the Neuroforma system. Virtual reality-based mirror therapy was administered for 15 minutes per day, five days per week, for four weeks.

    Other: Conventional Rehabilitation · Device: Virtual Reality-Based Mirror Therapy

  • Experimental
    Functional Electrical Stimulation-Assisted Cycling

    Participants received conventional rehabilitation combined with functional electrical stimulation-assisted cycling using the RT-300 system. FES-cycling therapy was administered five days per week for four weeks.

    Other: Conventional Rehabilitation · Device: Functional Electrical Stimulation-Assisted Cycling

Interventions

  • OtherConventional Rehabilitation

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

  • DeviceVirtual Reality-Based Mirror Therapy

    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.

  • DeviceFunctional Electrical Stimulation-Assisted Cycling

    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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Baseline and 4 weeks

Secondary outcomes

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

    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.

    Time frame: Baseline and 4 weeks

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

    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.

    Time frame: Baseline and 4 weeks

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

    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.

    Time frame: Baseline and 4 weeks

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

    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.

    Time frame: Baseline and 4 weeks

07

Study locations

1 site
  • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
    Ankara, Ankara 06800, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07666308
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Ezgi Aydın (Assistant Professor of Physical Medicine and Rehabilitation, Ankara City Hospital Bilkent) — Principal investigator
First posted
Jun 24, 2026
Start date
May 1, 2021
Primary completion
Feb 15, 2023
Completion
Feb 28, 2023
Last update
Jun 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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