Comparative Effects of Sensory Augmentation and Neuromodulation on Enhancing Motor Recovery Among Stroke Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-56
SponsorLahore University of Biological and Applied Sciences

About this trial

This study aims to evaluate the effectiveness of two rehabilitation techniques-Sensory Augmentation (using mirror therapy) and Neuromodulation (using transcranial direct current stimulation, tDCS)-in improving motor recovery among stroke survivors. Stroke often results in long-term impairments, particularly in upper limb motor function, which is critical for daily activities. Although current rehabilitation strategies help, more effective solutions are needed to enhance recovery. Participants, aged 45-65 with chronic stroke and upper extremity impairments, will be randomized into three groups: Group 1 will receive a combination of sensory augmentation (mirror therapy) and neuromodulation (tDCS) with routine physical therapy; Group 2 will receive sensory augmentation (mirror therapy) with routine physical therapy; and Group 3 will receive neuromodulation (tDCS) with routine physical therapy. The interventions will take place four times a week for 8 weeks, and participants will undergo motor function assessments, including the Fugl-Meyer Assessment and Jebsen-Taylor Test, before and after the intervention. The study will compare the effects of each intervention on motor recovery, specifically focusing on upper limb function and motor control. The findings could lead to improved rehabilitation protocols, offering stroke survivors better therapeutic options and enhancing their quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 45-65

Gender: both male and female

Ischemic stroke

Diagnosed cases of middle cerebral artery stroke by neurologist

Disqualifiers

Vestibular Dysfunction

Serious cognitive impairment,

Severe vision or visuospatial neglect

Spasticity (Modified Ashworth scale >3)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sensory Augmentation

    Other intervention

    Sensory Augmentation in this study will use Mirror Therapy, a non-invasive technique aimed at enhancing sensory feedback and promoting neuroplasticity. Participants will perform tasks with their unaffected arm while observing its reflection in a mirror placed in front of them, creating the illusion that the affected arm is moving. This visual feedback stimulates sensory pathways and encourages the brain to reorganize motor functions. Each session will last 15 minutes, conducted four times a week for 8 weeks, alongside Routine Physical Therapy. Mirror therapy differs from other rehabilitation methods by focusing on sensory-motor deficits through visual feedback, encouraging neuroplasticity and motor recovery, especially in chronic stroke patients with upper limb impairments.

  • Neuromodulation

    Other intervention

    Neuromodulation in this study will use Transcranial Direct Current Stimulation (tDCS), a non-invasive technique to modulate brain activity. A low electrical current will be applied to the motor cortex to enhance cortical excitability, promote neuroplasticity, and support motor relearning. tDCS helps reduce spasticity and facilitates recovery of motor functions by altering neural activity in targeted areas of the brain. Each session will last 20 minutes, with a 5-minute break, conducted four times a week for 8 weeks, alongside Routine Physical Therapy. tDCS stands apart from other therapies by directly stimulating brain regions to enhance neural plasticity, targeting motor function recovery through brain stimulation rather than external physical exercises alone.

  • Combination of Sensory Augmentation and Neuromodulation

    Other intervention

    The combined intervention will integrate Transcranial Direct Current Stimulation (tDCS) and Mirror Therapy to enhance motor recovery through both brain stimulation and sensory feedback. tDCS will apply a low electrical current to the motor cortex to modulate brain activity, promoting neuroplasticity, reducing spasticity, and facilitating motor relearning. Mirror Therapy will provide visual feedback by having participants perform tasks with their unaffected arm while observing its reflection in a mirror, simulating movement in the affected arm and stimulating sensory-motor pathways. This combined approach aims to maximize neuroplasticity by targeting both the brain and sensory processing systems. Each session will last 45 minutes: 15 minutes of Mirror Therapy, 15 minutes of tDCS, and 15 minutes of Routine Physical Therapy, conducted four times a week for 8 weeks.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Group 1 (combination of Multisensory Augmentation and Neuromodulation with Routine Physical Therapy)Experimental treatment 1 intervention
Group B: Group 2 (only sensory augmentation and Routine Physical Therapy)Experimental treatment 1 intervention
Group C: Group 3 (neuromodulation only and Routine Physical Therapy)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Fugl-Meyer Assessment Scale

The Fugl-Meyer Assessment (FMA) is a comprehensive, standardized tool used to assess motor function recovery in stroke patients, focusing on the upper limb, balance, and sensory function. The FMA includes subscales for motor function, sensory function, balance, and joint range of motion. The motor function subscale, which is particularly relevant in this study, evaluates voluntary movements, reflexes, coordination, and muscle strength of the upper limbs. The FMA scale ranges from 0 to 66 for the upper limb, with higher scores indicating better motor function. A score of 66 represents full motor recovery, while 0 indicates no motor function. Intermediate scores reflect varying levels of impairment and recovery. The FMA is widely used for its sensitivity in detecting changes over time, making it an effective tool for tracking motor recovery after stroke.

Time frame
Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.
2

Jebsen-Taylor Test

The Jebsen-Taylor Test of Hand Function (JTT) is a standardized assessment used to evaluate the functional use of the hands in everyday tasks, particularly for stroke patients. It includes seven subtests: writing, card turning, picking up small objects, simulated feeding, stacking checkers, and moving light and heavy objects. These tasks simulate common daily activities that require hand function. The JTT is scored based on the time it takes to complete each task, with shorter times indicating better hand function. The total score is the sum of the times for all subtests. Interpretation: Lower total times suggest better hand function, while longer times indicate greater motor impairment. The test helps assess the ability to perform functional tasks, providing a realistic measure of hand performance and recovery. It's valuable for evaluating improvements in motor function following rehabilitation interventions.

Time frame
Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.

Secondary outcomes

Other outcomes

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