Hemiplegia, Stroke, Upper Extremity Impairments
Conditions
Keywords
Stroke rehabilitation, Upper extremity rehabilitation, Virtual reality, Mirror therapy, Functional electrical stimulation, FES cycling
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.
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.
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.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessments were performed by an experienced physiatrist who was blinded to participants' group allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motor Recovery Assessed by the Brunnstrom Recovery Stages | 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. |
| Change in Functional Independence Assessed by the Functional Independence Measure | 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. |
| Change in Upper Extremity Use in Daily Activities Assessed by the Motor Activity Index-28 | 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. |
| Change in Quality of Life Assessed by the Short Form-36 Health Survey | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed