Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:15 AM
Study NCT ID:
NCT07448532
Status:
RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effects of Functional Electrical Stimulation and Mirror Therapy for Foot Clearance Among Patients With Sub-acute Stroke
Sponsor:
Lahore University of Biological and Applied Sciences
Organization:
Study Overview
Official Title:
Comparative Effects of Functional Electrical Stimulation and Mirror Therapy for Foot Clearance Among Patients With Sub-acute Stroke
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FES MT CVA
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1334-2744 | REGISTRY | Rohma Shah | View |