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

24 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: Conventional Rehabilitation
A conventional rehabilitation program including neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training.
Sperimentale: 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.
Altro: Conventional Rehabilitation
A conventional rehabilitation program including neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training.
Dispositivo: 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.
Sperimentale: 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.
Altro: Conventional Rehabilitation
A conventional rehabilitation program including neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Motor Recovery Assessed by the Brunnstrom Recovery Stages
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ankara City Hospital Bilkent

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2021

Completamento primario (Effettivo)

15 febbraio 2023

Completamento dello studio (Effettivo)

28 febbraio 2023

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2026

Primo Inserito (Effettivo)

24 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AYBU-26379996-55

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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