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NCT Number: NCT07629011

Effects of Mental Imagery Training Combined With Task Oriented Training by EMG-Driven Soft Robotic Hand Stroke in Stroke

This randomized controlled trial is to determine the effects of robotic hand training in improving upper limb motor function and coordination with and without mental imagery training in chronic stroke patients

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Railway General Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

Location status: Recruiting

Location contact

Arshad Nawaz Malik, PhD Rehab

CONTACT

[email protected]

03334503754

Ayesha Umer, MS-NMPT*

PRINCIPAL_INVESTIGATOR

About this study

The World Health Organization (WHO) defines stroke as a condition marked by the sudden onset of clinical symptoms reflecting a focal or global disturbance in brain function, lasting more than 24 hours or leading to death, with no apparent cause other than a vascular origin. WHO estimates that approximately 15 million people worldwide experience a stroke each year. It continues term disability .Stroke remains a widespread concern in developing nations, but it continues to be largely overlooked. One of the most affected areas following stroke is the impairment of motor skill.

Motor deficits, especially hemiparesis, are frequently seen in stroke survivors and greatly hinder their ability to carry out daily activities, which in turn negatively influences their overall quality of life. Upper limb motor deficits are frequently seen in stroke survivors, with nearly 78% affected. Approximately 50% of them struggle particularly with hand function needed for daily living activities. Compensatory movements are frequently seen during upper extremity tasks, often involving proximal joints compensating for limited distal joint function. Most notable improvements in upper extremity motor function usually take place within the first six months after stroke onset. However, around 65% of stroke survivors continue to experience difficulty using their affected hand during the chronic stage. As a result, restoring upper extremity function especially hand function is crucial for chronic stroke survivors to achieve independence in daily activities.

Previous research has shown that task-oriented training can greatly improve upper extremity motor function, even in individuals with chronic stroke. The task- oriented approach is a functional activity-based method that emphasizes practicing specific tasks repeatedly to improve performance. The task-oriented approach incorporates such functional tasks, making it a practical intervention for patients. This treatment focuses on enhancing motor function by encouraging active use of the affected upper limb because patients use the unaffected side more during arm action, it is necessary to apply therapy to the affected arm.

Another technique used with stroke patients is Mental imagery(MI) /Mental Practice(MP) technique does not require great economic investments and can be performed anywhere, because no special equipment is needed. It is safe, given that the technique can be repeated many times without great physical effort. MI is a technique in which individuals imagine themselves performing physical tasks without any actual movement. Theory suggests that Mental rehearsal of a task activates the similar regions of the brain as activated by physical performance of the same task. Recent research indicates that when MI is combined with physical practice, it can significantly improve the recovery of motor functions. In MI, reactivation occurs when a movement is mentally simulated rather than physically executed, reflecting a voluntary effort. This allows individuals to develop and refine motor skills without actual movement.

Recently, wearable robotic hands have attracted considerable interest as rehabilitation tools in hospitals and therapy centers. These robotic devices help stroke patients perform repetitive hand functions such as opening and grasping. Research has demonstrated that rehabilitation using wearable robotic hands or gloves, which are activated by surface electromyography signals, combining with TOT can improve motor performance and reduce abnormal muscle tone patterns.

This study proposes integrating MI with TOT using soft robotic hand to potentially enhance motor learning and functional recovery by simultaneously engaging both cognitive and sensorimotor pathways. The combination could provide a synergistic effect, maximizing cortical activation and functional gains in stroke survivors with upper limb deficits. By investigating this approach, the study aims to contribute to more effective rehabilitation protocols for improving UL function post-stroke. This combination may lead to faster recovery and better motor performance without extra financial burden. This information can help rehabilitation professionals assess upper limb motor recovery, monitor progress, and develop targeted interventions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants clinically diagnosed with stroke in chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after stroke.
  • 18-70 years of age.
  • Sufficient cognition to follow simple instructions and understand the content and purpose of study (MMSE score 28)
  • Able to sit up for at least 45 minutes.
  • Detectable residual signals from the affected side's Flexor digitorum (FD) and Extensor Digitorum (ED) muscles.
  • Modified Ashworth Scale (MAS) score of finger extensor less than or to 3
  • Ability to provide informed consent

Exclusion criteria

  • Patients with severe dysphasia with inadequate communication.
  • Any additional medical or psychological condition affecting their ability to comply with the study protocol.
  • History of other neurological disease or psychiatric disorders, including alcoholism and substance abuse

Treatment and study plan

Mental imagery training combined with Robotic hand training

Other

Participants will receive combined training of robotic hand-assisted task practice and mental imagery training over 7 weeks, 3 sessions per week, totaling 20 sessions.

Each session (~60 minutes) conducted in a quiet room with the patient seated upright (hips, knees, ankles at 90°, forearms on table). Training involves real-life object handling tasks using three grip types:

  • Spherical grip (cricket ball - 109g, 75mm)
  • Tripod grip (woodblock - 74g, 50mm)
  • Tip pinch grip (small cube - 8g, 25mm) For each task (15 minutes), MIT duration will be 10 minutes
  • 2 repetitions - Watch task video (first-person view)
  • 5 repetitions - Imagine performing the task (eyes closed, paretic hand)
  • 3 repetitions - Perform the task with soft robotic hand assistance
  • The above sequence is repeated twice per task.

Robotic hand training

Other

Each session included a 5-minute warm-up, followed by three 15-minute EMG-driven, robot-assisted task blocks and two 5-minute breaks.

Robotic Hand Tasks include: Real-life object handling using three grip types:

  • Spherical grip - Cricket ball (109g, 75mm)
  • Tripod grip - Woodblock (74g, 50mm)
  • Tip pinch grip - Small cube (8g, 25mm)

Muscle Monitoring:

EMG signals recorded from flexor digitorum, extensor digitorum, biceps brachii, and triceps brachii.

Maximum Voluntary Contraction assessed before each session; EMG activation threshold set at 3×SD above baseline.

Training Activities will include: Grasping, lifting, holding, transporting, and releasing objects with robotic assistance and verbal guidance.

Each 15-minute block included ~30-40 repetitions per task.

Primary outcomes

  1. Fugl-Meyer Assessment Upper Extremity (FMA-UE).

    Time frame: 6 weeks

    Evaluate sensorimotor impairment after stroke, especially in the upper limb. 3 Sections, (A) UPPER EXTREMITY

    • Reflex Activity on paretic side (2 items) Bicep reflex Tricep reflex
    • Volitional movements within synergies pattern Flexion synergy ,Extensor synergy
    • Volitional movement mixing synergies
    • Volitional movement with little or no synergy

    (B) Wrist Stability at 15 dorsiflexion (DF) (Elbow at 90)Repeated (DF) (Elbow at 90) Stability at 15 dorsiflexion (DF) (Elbow at 0) Circumduction (C)Hand Mass Flexion ,Mass Extension GRASP Finger mass flexion /Finger mass extension Thumb adduction ,Opposition, Cylindrical grip ,Spherical grip

    Normal = Score 0-66 A UE /36 B Wrist /10 C Hand /14

  2. Action research arm test (ARAT)

    Time frame: 6 weeks

    The ARAT is an observer-rated, performance-based assessment designed to measure upper extremity function and dexterity, especially after stroke or other cortical injuries.

    4 Subscale

    • Grasp (6 items)
    • Grip (4 items)
    • Pinch (6 items)
    • Gross movement (3 items). Total score = 57
  3. Box and block Test (BBT)

    Time frame: 6 weeks

    Measures gross manual dexterity and speed Equipment: Wooden box (≈ 53.7 × 25.4 × 8.5 cm) with a partition, plus 150-152 blocks (≈ 2.5 cm cubes) Primary score: Number of blocks successfully transferred in 60 seconds (per hand).Only blocks completely transferred count; dropped blocks are excluded

Secondary outcomes

  1. Modified ashworth scale (MAS)

    Time frame: 6 weeks

    Measure muscle spasticity by assessing resistance during passive soft-tissue stretching.

    0-4 Point scale Used to measure spasticity of finger, wrist, elbow Scoring 0,1,1+,2,3,4

Study contacts

Contact information is provided by the study sponsor or research team.

Arshad Nawaz Malik, PhD Rehab

CONTACT

[email protected]

03334503754

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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