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

NCT07266662 | Recruiting DMC

• 1 other identifier: UBAS/ERB/FoRS/25/033 Asad Ali
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke (CVA) or Transient Ischemic Attack

Keywords

neuromuscular rehabilitation; sensory augmentation; neuromodulation; motor recovery; upper limb function; neuroplasticity; Fugl-Meyer Assessment; Jebsen-Taylor Test

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Study Arms (3)

Group 1 (combination of Multisensory Augmentation and Neuromodulation with Routine Physical Therapy)

EXPERIMENTAL

Group 1 will receive a combination of Multisensory Augmentation (Mirror Therapy) and Neuromodulation (Transcranial Direct Current Stimulation - tDCS) along with Routine Physical Therapy. The interventions will be administered four times a week over an 8-week period. The multisensory augmentation component will involve Mirror Therapy, where participants will perform motor tasks with their unaffected arm while observing its reflection in a mirror placed in front of them, simulating movement of the affected arm. This therapy enhances sensory feedback and promotes neuroplasticity. The neuromodulation component will involve tDCS, where a low electrical current will be applied to the motor cortex to modulate cortical excitability and promote neuroplastic changes, supporting motor relearning and reducing spasticity. Each session will consist of 15 minutes of Mirror Therapy and 15 minutes of tDCS stimulation, followed by Routine Physical Therapy, which includes task-oriented training and refl

Other: Combination of Sensory Augmentation and Neuromodulation

Group 2 (only sensory augmentation and Routine Physical Therapy)

EXPERIMENTAL

Group 2 will receive Sensory Augmentation (Mirror Therapy) in combination with Routine Physical Therapy. The interventions will be administered four times a week over an 8-week period. Mirror Therapy will involve participants performing motor tasks with their unaffected arm while observing its reflection in a mirror placed in front of them, creating the illusion of movement in the affected arm. This technique enhances sensory feedback and promotes neuroplasticity, which is critical for motor recovery in stroke survivors. In addition to Mirror Therapy, participants will also undergo Routine Physical Therapy for 20 minutes per session. The physical therapy will include task-oriented training and reflex inhibitory exercises designed to improve motor control, strength, and coordination. Each session will last 45 minutes, with 25 minutes dedicated to the sensory augmentation intervention and physical therapy combined. This arm aims to assess the effects of sensory augmentation alone on mot

Other: Sensory Augmentation

Group 3 (neuromodulation only and Routine Physical Therapy)

EXPERIMENTAL

Group 3 will receive Neuromodulation (Transcranial Direct Current Stimulation - tDCS) in combination with Routine Physical Therapy. The interventions will be administered four times a week over an 8-week period. tDCS involves the application of a low electrical current to the motor cortex, modulating cortical excitability to promote neuroplasticity and support motor relearning while reducing spasticity. The tDCS session will last 20 minutes, with a 5-minute break during the session. In addition to tDCS, participants will also undergo Routine Physical Therapy for 20 minutes per session. The physical therapy will include task-oriented training and reflex inhibitory exercises designed to enhance motor control, strength, and functional movement. Each session will last 45 minutes, with 20 minutes dedicated to tDCS and 20 minutes to physical therapy. This arm will evaluate the impact of neuromodulation alone on motor recovery when combined with traditional physical rehabilitation techniques

Other: Neuromodulation

Interventions

Neuromodulation OTHER

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.

Also known as: Routine Physical Therapy

Group 3 (neuromodulation only and Routine Physical Therapy)

Combination of Sensory Augmentation and Neuromodulation OTHER

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.

Also known as: Routine Physical Therapy

Group 1 (combination of Multisensory Augmentation and Neuromodulation with Routine Physical Therapy)

Sensory Augmentation OTHER

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.

Also known as: Routine Physical Therapy

Group 2 (only sensory augmentation and Routine Physical Therapy)

Eligibility Criteria

• Age: 45 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 45-65
• Gender: both male and female
• Ischemic stroke
• Diagnosed cases of middle cerebral artery stroke by neurologist
• Stage of recovery - Chronic (more than 6 months)
• Burnstromm recovery stage 3
• Good Compliance

You may not qualify if:

• Vestibular Dysfunction
• Serious cognitive impairment,
• Severe vision or visuospatial neglect
• Spasticity (Modified Ashworth scale \>3)
• Upper extremity contractures
• Upper extremity fractures
• Orthopedic disease
• Neurological conditions (other than stroke)
• Recurrence of stroke or epilepsy during the study period
• Serious systemic impairment or concomitant diseases
• Patients refused to participate in the experiment

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (2)

Lahore University of Biological and Applied Sciences

Lahore, Punjab Province, Pakistan

NOT YET RECRUITING

Pakistan Society of Rehabilitation and Differently Abled Hospital

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (5)

• Shahid J, Kashif A, Shahid MK. A Comprehensive Review of Physical Therapy Interventions for Stroke Rehabilitation: Impairment-Based Approaches and Functional Goals. Brain Sci. 2023 Apr 25;13(5):717. doi: 10.3390/brainsci13050717.

  PMID: 37239189 BACKGROUND

• Norman SL, Wolpaw JR, Reinkensmeyer DJ. Targeting neuroplasticity to improve motor recovery after stroke: an artificial neural network model. Brain Commun. 2022 Oct 21;4(6):fcac264. doi: 10.1093/braincomms/fcac264. eCollection 2022.

  PMID: 36458210 BACKGROUND

• Harris JE, Eng JJ. Paretic upper-limb strength best explains arm activity in people with stroke. Phys Ther. 2007 Jan;87(1):88-97. doi: 10.2522/ptj.20060065. Epub 2006 Dec 19.

  PMID: 17179441 BACKGROUND

• Li S. Spasticity, Motor Recovery, and Neural Plasticity after Stroke. Front Neurol. 2017 Apr 3;8:120. doi: 10.3389/fneur.2017.00120. eCollection 2017.

  PMID: 28421032 BACKGROUND

• Coupland AP, Thapar A, Qureshi MI, Jenkins H, Davies AH. The definition of stroke. J R Soc Med. 2017 Jan;110(1):9-12. doi: 10.1177/0141076816680121. Epub 2017 Jan 13. No abstract available.

  PMID: 28084167 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Nabeela Dawood

  Lahore University of Biological and Applied Sciences

  STUDY CHAIR

Central Study Contacts

Syed Asad Ali, Doctor of Physical Therapy

CONTACT

+923224739971; thisisasadali01@gmail.com

Nabeela Dawood, NMPT

CONTACT

+923315337445; nabeela.dawood@ubas.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)