Stroke (Subacute)
Conditions
Keywords
Fugl-Meyer Assessment, Functional Independence Measure, Lower limb rehabilitation, Stroke (subacute), Foot Clearance, Neuromuscular Rehabilition, Mirror therapy (MT), Functional Electrical Stimulation (FES)
Brief summary
This study aims to evaluate the effectiveness of two rehabilitation techniques- Functional Electrical Stimulation (FES) and Mirror Therapy (MT)-in improving motor recovery among stroke survivors. Stroke often results in long-term impairments, particularly in foot clearance, which is critical for daily activities. Although current rehabilitation strategies help, more effective solutions are needed to enhance recovery. Participants, aged 18- 85 years old with subacute stroke and foot clearance impairments, will be randomized into two groups: Group A will receive functional electrical stimulation (FES) with routine physical therapy; and Group B will receive mirror therapy (MT) with routine physical therapy. The interventions will take place three times a week for 4 weeks, and participants will undergo motor function assessments, including the Fugl-Meyer Assessment and Functional Independence Measure, before and after the intervention. The study will compare the effects of each intervention on motor recovery, specifically focusing on tibialis anterior function and motor control. The findings could lead to improved rehabilitation protocols, offering stroke survivors better therapeutic options and enhancing their quality of life.
Detailed description
Stroke is one of the leading causes of disability worldwide, often leading to long-term impairments in motor function, particularly in the lower limbs. These impairments can severely affect a person's ability to perform daily tasks, reducing their independence and quality of life. The rehabilitation process for stroke survivors typically includes physical therapy aimed at improving motor control, balance, and functionality of the affected limbs. While traditional rehabilitation strategies are effective, there is a growing interest in enhancing recovery by improving foot clearance which is a common impairment after stroke through advanced techniques like sensory augmentation and neuromodulation. This study will focus on evaluating the comparative effects of two innovative rehabilitation approaches Mirror Therapy (MT) and functional electrical stimulation (FES) on motor recovery in sub-acute stroke survivors. These two techniques have shown promising results in improving motor function in stroke patients altogether, but their individual efficacy and comparison remains unclear. Intervention Strategies: Mirror therapy is a non-invasive technique that involves using a mirror to create the illusion of movement in the affected limb by reflecting the movement of the unaffected limb. This process enhances the sensory feedback and promotes neuroplasticity, which is the brain's ability to reorganize and form new neural connections. Mirror therapy has been shown to reduce spasticity, improve sensory functions like proprioception, and facilitate the restoration of motor function. Neuromodulation: functional electrical stimulation (FES) is a non-invasive brain stimulation technique that uses a low electrical current to stimulate neuronal activity in specific areas of the brain. To improve foot clearance in stroke survivors, FES is applied to the dorsiflexors to promote stimulation, to promote neuroplasticity, and facilitate the relearning of motor tasks. While previous studies have demonstrated the effectiveness of FES and Mirror Therapy combined but its individual impact has not been fully explored. Study Design and Groups: This randomized controlled trial will involve 38 subacute stroke patients aged 18-75 who have lower extremity motor impairments along with inadequate foot clearance and inability to perform activities of daily living (ADLs). The participants will be randomly assigned to one of two groups: Group A (Experimental Group):functional electrical stimulation (FES) along with routine physical therapy. Group B: (Experimental group) mirror therapy (MT) combined with routine physical therapy. Functional Electrical Stimulation (FES) was used 3 sessions a week for 4 weeks to address the impaired foot clearance in the sub acute stroke population. Each session consisted of 30 minutes of stimulation to the tibialis anterior. The intensity (current amplitude) of the stimulation was set to a level that was just sufficient to elicit ankle dorsiflexion, but not high enough to elicit discomfort; the pulse frequency was kept around 35 40 Hz, with a pulse width of about 200 300 µs. Stimulation was given using surface electrodes over the proximal portion of the deep peroneal nerve while subjects were either sitting or lying supine. In an hour of FES therapy, patients completed multiple 5-minute short sessions of alternating 15 seconds of rest and 15 seconds of active foot clearance (dorsiflexion) along with auditory/text cues. The FES device provided stimulation to the appropriate muscles to facilitate control of motor function for the weak foot during these activities. Outcome was assessed using the FMA lower limb motor subscale (FMA-LE) at baseline, and week 4. Mirror therapy as an intervention was delivered five days per week for four weeks duration in post stroke patients. Each session consisted of 30 minutes of mirror therapy in addition to 60-120 minutes of conventional rehabilitation exercises, providing a standardized intensity across participants. The assessments were done at baseline and immediately after treatment using FIM motor for lower limb. During this treatment session, patients were seated with a vertical mirror (40×70 cm) positioned between the lower limbs so that only the non-paretic extremity was visible in the mirror. Patients were instructed to perform repeated ankle dorsiflexion and plantarflexion movements of the non-paretic limb while watching its mirror image, giving visual feedback that the paretic limb was moving, while the paretic side remained still. In my research, I followed the same MT setup, exercise type, and session length but adjusted the frequency to three sessions per week rather than five, based on patient availability and tolerance and condition. Statistical analyses will include paired-sample t test and Kolmogorov-Smirnov test to examine the effects of interventions on experimental group and control group on the primary and secondary outcomes. Post-intervention comparisons will be made to assess the differential impact of each intervention. Safety and Ethics: This study has been approved by the institutional review board (IRB) of Lahore University of Biological and Applied Sciences, and all participants will provide informed consent before participating. To ensure the safety of participants, all sessions will be conducted under the supervision of trained physical therapists. Minimal risks associated with the study include mild discomfort or fatigue during the physical assessments and interventions. If any participant experiences adverse effects, they will be promptly withdrawn from the study. The study will also ensure the confidentiality of all participant data. Personal information will be anonymized, and data will be stored securely. Participation in the study is voluntary, and participants may withdraw at any time without facing any negative consequences. Significance and Potential Impact: This study has the potential to significantly impact stroke rehabilitation practices by providing evidence on the Comparative Effects of Functional Electrical Stimulation and Mirror Therapy for Foot Clearance among patients with sub-acute Stroke. The results may guide clinicians in developing more effective rehabilitation protocols and inform future research on rehabilitation strategies. Given the growing incidence of stroke worldwide, particularly in low- and middle-income countries, this research could pave the way for accessible, cost-effective, and non-invasive therapeutic interventions. It may offer stroke survivors, especially those in resource-limited settings, improved chances for motor recovery and a better quality of life. Furthermore, this study will contribute valuable data to the scientific community, offering insights into the combined effects of mirror therapy and FES, which could enhance the evidence base for stroke rehabilitation. Conclusion: By comparing the Effects of Functional Electrical Stimulation and Mirror Therapy for Foot Clearance among patients with sub-acute Stroke, this study aims to identify the most effective intervention(s) for improving motor recovery in stroke survivors. The findings will not only contribute to the field of neurorehabilitation but may also offer new therapeutic options for patients in need of effective, evidence-based treatments for motor impairments post-stroke.
Interventions
OTHERNeuromodulators
Functional Electrical Stimulation was administered to participants in the experimental group to facilitate activation of the ankle dorsiflexor muscles, primarily the tibialis anterior, to improve impaired foot clearance in sub-acute stroke patients. Surface electrodes were placed over the tibialis anterior muscle of the affected limb to elicit ankle dorsiflexion. Electrical stimulation was delivered at an intensity sufficient to produce visible and functional ankle dorsiflexion without causing discomfort. The stimulation aimed to enhance neuromuscular recruitment, improve voluntary motor control, and promote motor relearning through repeated activation of the weakened muscles during functional tasks. Each FES session lasted 30 minutes, followed by 20 minutes of routine physical.
OTHERSensory Agumentation
Mirror Therapy was administered to participants in the comparison group as a sensory augmentation intervention to enhance motor recovery through visual feedback. A vertical mirror was placed between the lower limbs in the sagittal plane, such that the reflection of the non-paretic limb was visible while the paretic limb was concealed from view. Participants were instructed to perform repeated ankle dorsiflexion and plantarflexion movements with the non-paretic limb while observing its reflection in the mirror. This created the visual illusion that the paretic limb was moving normally, providing visual feedback to the brain. Mirror Therapy aims to stimulate mirror neuron systems and sensorimotor cortical areas, encouraging cortical reorganization and improved motor control of the affected limb. During the session, the paretic limb remained relaxed while the participant focused on the mirror image. Each Mirror Therapy session lasted 30 minutes, followed by 20 minutes of routine physical
Sponsors
Lahore University of Biological and Applied Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This study will use a single-blind design, where the participants will be unaware of the specific intervention group they have been assigned to (i.e., whether they are receiving the combination of sensory augmentation and neuromodulation, sensory augmentation alone, or neuromodulation alone). This masking ensures that participant expectations do not influence their responses to the interventions. However, the treating therapists and study coordinators who administer the interventions and assess outcomes will not be masked, as they will be responsible for the direct management of the interventions and data collection. This design allows for an objective evaluation of the effects of the interventions while minimizing potential biases from participant expectations.
Intervention model description
Not Needed
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient aged 18-85 years of age, who experienced stroke within ≤6 months. * The Fugl-Meyer motor assessment of lower extremity (FMA-LE) was conducted by physiotherapist in the hospital, and score required to be ≥ 20 points. * Participants possessed healthy nerves, neuromuscular junctions, muscles tissues, and a sufficient range of motion in dorsiflexor and plantarflexion. * The subjects could walk independently on a treadmill for at least 2 min without without experiencing adverse reaction to FES. * Patients who received more 24 scores on Mini Mental State Exam and could comprehend and follow the information researcher provides. * No orthopedic diseases in upper and lower extremities. * Patients with functional ambulation classification (FAC) score of 3 or 4 were included (FAC is a scale of 0-5, where 3 indicates supervision or standby guarding and 4 indicates independent on level surfaces. * Patients with inadequate ankle dorsiflexion during the swing phase of gait. * Patients with adequate minimal stability at the ankle during stance with stimulation.
Exclusion criteria
* Patients with cardiac pacemaker, those with skin lesions, who could not be treated due to spasticity within the last three months, and vestibular and cerebellar lesions or deaf- blindness were excluded. * Patients with past or current epilepsy, uncontrolled seizure disorder, mental disorders and all neurological disorders except stroke. * Patients with severe edema of lower extremities or patients of vascular disorders like deep vein thrombosis or thromboembolisms and severe atheroscelerosis of lower extremities. * Subjects with any musculoskeletal dysfunction that would potentially affect gait and causes risk of falls. * We excluded patients with pregnancy, plantar flexion contracture, and severe hemi-neglect. * Subjects with hip or knee prostheses made of metal on the lower limb were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Foot Clearance | From the enrollment to the end of treatment at 4 weeks | Sub-acute stroke survivors present with hemi-paretic gait often presents with reduced hip, knee, and ankle flexion during swing phase along with decreased joint motion and power in late stance and pre-swing phase. These impairments result in making foot clearance more difficult. A crucial walking measure that signals tripping is minimum foot clearance (MFC), which takes place in the mid-swing phase of the gait cycle in our study we intend to improve foot clearance in subacute stroke survivors primarily. The tool used for this purpose is Fugl-Meyer Assessment (FMA) a comprehensive, standardized tool used to assess motor function recovery in stroke patients, focusing on the lower limb, balance, and sensory function. The outcomes that were studied in stroke patients are foot clearance and improvement in ADLs. This tool is stroke-specific, performance-based scale designed to evaluate motor recovery, with the Lower Extremity subscale assessing hip, knee, and ankle function, including ankle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity of Daily Living (ADLs) | From the enrollment to the end of treatment at 4 weeks | Stroke survivors need some assistance or are fully dependent on their caregivers for activities of daily living (ADLs). Reduced stroke hospitalization and efficiency-driven care increase the need for early prognosis of basic ADL outcomes (e.g., dressing, mobility, bathing) to optimize early stroke management. Our secondary outcome is improvement in ADLs for which we have used Functional Independence Measure (FIM) is one of the most widely used outcome measures in stroke rehabilitation. The Motor-FIM, which includes items related to transfers, locomotion, and stair climbing, is particularly relevant to mobility outcomes. The FIM demonstrates excellent internal consistency, with Cronbach's alpha values reported between 0.93 and 0.95 for the total scale, and approximately 0.95 for the motor subscale. These findings confirm that the FIM is a reliable and valid instrument for assessing functional independence in ADLs and mobility performance among stroke patients. |
Countries
Pakistan
Contacts
CONTACTNabeela Dawood
STUDY_CHAIRNabeela Dawood
Lahore University of Biological and Applied Sciences
PRINCIPAL_INVESTIGATORRohma Shah
Lahore College of Physical Therapy
PRINCIPAL_INVESTIGATORAyesha Hassan
Lahore College of Physical Therapy
PRINCIPAL_INVESTIGATORRabiya Haroon
Lahore College of Physical Therapy
Outcome results
None listed