StrokeNCT07666308
Virtual Reality-Based Mirror Therapy and FES-Cycling in Stroke Rehabilitation
A study testing Conventional Rehabilitation, Virtual Reality-Based Mirror Therapy and Functional Electrical Stimulation-Assisted Cycling in people with Stroke and Hemiplegia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiplegia, Upper Extremity Impairments
- What is being tested?
- Conventional Rehabilitation, Virtual Reality-Based Mirror Therapy and Functional Electrical Stimulation-Assisted Cycling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
Ankara, Ankara, 06800
About this study
Official title: 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.
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.
- Conditions
- Stroke, Hemiplegia, Upper Extremity Impairments
- Being tested
- Conventional Rehabilitation, Virtual Reality-Based Mirror Therapy, Functional Electrical Stimulation-Assisted Cycling
- Keywords
- Stroke rehabilitation, Upper extremity rehabilitation, Virtual reality, Mirror therapy, Functional electrical stimulation, FES cycling
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RehabilitationOther
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 TherapyDevice
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 CyclingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Conventional Rehabilitation; Device: Functional Electrical Stimulation-Assisted Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
Secondary outcomes (4)
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.
Measured: Baseline and 4 weeks
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.
Measured: Baseline and 4 weeks
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.
Measured: Baseline and 4 weeks
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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 May 2021
- Primary completion15 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Aydın, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666308
- Sponsor's protocol ID
- AYBU-26379996-55
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Virtual Reality-Based Mirror Therapy and Functional Electrical Stimulation-Assisted Cycling for Upper Extremity Rehabilitation After Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07666308
- Acronym / sponsor ID
- AYBU-26379996-55
- Conditions
- Stroke, Hemiplegia, Upper Extremity Impairments
- Keywords
- Stroke rehabilitation, Upper extremity rehabilitation, Virtual reality, Mirror therapy, Functional electrical stimulation, FES cycling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation | Active comparator | Other: Conventional RehabilitationParticipants 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. |
| Virtual Reality-Based Mirror Therapy | Experimental | Other: Conventional Rehabilitation, Device: Virtual Reality-Based Mirror TherapyParticipants 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. |
| Functional Electrical Stimulation-Assisted Cycling | Experimental | Other: Conventional Rehabilitation, Device: Functional Electrical Stimulation-Assisted CyclingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional RehabilitationA conventional rehabilitation program including neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training. | Other | Conventional Rehabilitation, Functional Electrical Stimulation-Assisted Cycling, Virtual Reality-Based Mirror Therapy |
| Virtual Reality-Based Mirror TherapyVirtual 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. | Device | Virtual Reality-Based Mirror Therapy |
| Functional Electrical Stimulation-Assisted CyclingFunctional 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. | Device | Functional Electrical Stimulation-Assisted Cycling |
Primary outcome
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.
4 secondary outcomes
Change in Motor Recovery Assessed by the Brunnstrom Recovery Stages
Time frame: Baseline and 4 weeks
Change in Functional Independence Assessed by the Functional Independence Measure
Time frame: Baseline and 4 weeks
Change in Upper Extremity Use in Daily Activities Assessed by the Motor Activity Index-28
Time frame: Baseline and 4 weeks
Change in Quality of Life Assessed by the Short Form-36 Health Survey
Time frame: Baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Rehabilitation, Virtual Reality-Based Mirror Therapy and Functional Electrical Stimulation-Assisted Cycling in people with Stroke and Hemiplegia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.