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

24. juni 2026 opdateret af: Ezgi Aydın, Ankara City Hospital Bilkent

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

  • Tyrkiet (Türkiye)
    • Ankara
      • Ankara, Ankara, Tyrkiet (Türkiye), 06800
        • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Deltagelseskriterier

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Berettigelseskriterier

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Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Andet: Conventional Rehabilitation
A conventional rehabilitation program including neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training.
Eksperimentel: 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.
Andet: Conventional Rehabilitation
A conventional rehabilitation program including neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training.
Enhed: Virtual 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.
Eksperimentel: 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.
Andet: Conventional Rehabilitation
A conventional rehabilitation program including neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training.
Enhed: Functional 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment
Tidsramme: 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.
Baseline and 4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Motor Recovery Assessed by the Brunnstrom Recovery Stages
Tidsramme: 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.
Baseline and 4 weeks
Change in Functional Independence Assessed by the Functional Independence Measure
Tidsramme: 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.
Baseline and 4 weeks
Change in Upper Extremity Use in Daily Activities Assessed by the Motor Activity Index-28
Tidsramme: 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.
Baseline and 4 weeks
Change in Quality of Life Assessed by the Short Form-36 Health Survey
Tidsramme: 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.
Baseline and 4 weeks

Samarbejdspartnere og efterforskere

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Sponsor

Ankara City Hospital Bilkent

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2021

Primær færdiggørelse (Faktiske)

15. februar 2023

Studieafslutning (Faktiske)

28. februar 2023

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

18. juni 2026

Først opslået (Faktiske)

24. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AYBU-26379996-55

Plan for individuelle deltagerdata (IPD)

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