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

NCT07666308 | Completed

• 1 other identifier: AYBU-26379996-55
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Hemiplegia; Upper Extremity Impairments

Keywords

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

Outcome Measures

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.

  Baseline and 4 weeks

Secondary Outcomes (4)

• Change in Motor Recovery Assessed by the Brunnstrom Recovery Stages

  Baseline and 4 weeks

• Change in Functional Independence Assessed by the Functional Independence Measure

  Baseline and 4 weeks

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

  Baseline and 4 weeks

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

  Baseline and 4 weeks

Study Arms (3)

Conventional Rehabilitation

ACTIVE COMPARATOR

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

Virtual Reality-Based Mirror Therapy

EXPERIMENTAL

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

Functional Electrical Stimulation-Assisted Cycling

EXPERIMENTAL

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

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.

Conventional Rehabilitation; Functional Electrical Stimulation-Assisted Cycling; Virtual Reality-Based Mirror Therapy

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.

Virtual Reality-Based Mirror Therapy

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.

Functional Electrical Stimulation-Assisted Cycling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments were performed by an experienced physiatrist who was blinded to participants' group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Medicine and Rehabilitation

Model Details: Participants were randomly assigned in a 1:1:1 ratio to three parallel intervention groups: conventional rehabilitation, conventional rehabilitation combined with virtual reality-based mirror therapy, and conventional rehabilitation combined with functional electrical stimulation-assisted cycling.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: May 1, 2021
• Primary Completion: February 15, 2023
• Study Completion: February 28, 2023
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)