StrokeNCT07629011
Effects of Mental Imagery Training Combined With Task Oriented Training by EMG-Driven Soft Robotic Hand Stroke in Stroke
A study testing Mental imagery training combined with Robotic hand training and Robotic hand training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Mental imagery training combined with Robotic hand training and Robotic hand training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Railway General Hospital
Rawalpindi, Punjab Province, 44000
Arshad Nawaz Malik, PhD Rehab, 03334503754, Arshad.nawaz@riphah.edu.pk
Ayesha Umer, MS-NMPT*
About this study
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
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- Mental imagery training combined with Robotic hand training, Robotic hand training
- Keywords
- Stroke rehabilitation, Mental imagery training, Task oriented training, upper limb rehabilitation, motor function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental imagery training combined with Robotic hand trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mental imagery training with Robotic hand training Group | Experimental | Not described Receives: Other: Mental imagery training combined with Robotic hand training |
| Robotic hand training | Active comparator | Not described Receives: Other: Robotic hand training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Upper Extremity (FMA-UE).
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
Measured: 6 weeks
Action research arm test (ARAT)
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
Measured: 6 weeks
Box and block Test (BBT)
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
Measured: 6 weeks
Secondary outcomes (1)
Modified ashworth scale (MAS)
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Apr 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Umer, MS-NMPT*, Principal investigator, Riphah International Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629011
- Sponsor's protocol ID
- 02261/ Ayesha Umer
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mental Imagery Training Combined With Task Oriented Training by EMG-Driven Soft Robotic Hand Stroke in Stroke
- ClinicalTrials.gov ID
- NCT07629011
- Acronym / sponsor ID
- 02261/ Ayesha Umer
- Conditions
- Stroke
- Keywords
- Stroke rehabilitation, Mental imagery training, Task oriented training, upper limb rehabilitation, motor function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental imagery training with Robotic hand training Group | Experimental | Other: Mental imagery training combined with Robotic hand training |
| Robotic hand training | Active comparator | Other: Robotic hand training |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental imagery training combined with Robotic hand trainingParticipants 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: 1. Spherical grip (cricket ball - 109g, 75mm) 2. Tripod grip (woodblock - 74g, 50mm) 3. Tip pinch grip (small cube - 8g, 25mm) For each task (15 minutes), MIT duration will be 10 minutes 1. 2 repetitions - Watch task video (first-person view) 2. 5 repetitions - Imagine performing the task (eyes closed, paretic hand) 3. 3 repetitions - Perform the task with soft robotic hand assistance 4. The above sequence is repeated twice per task. | Other | Mental imagery training with Robotic hand training Group |
| Robotic hand trainingEach 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: 1. Spherical grip - Cricket ball (109g, 75mm) 2. Tripod grip - Woodblock (74g, 50mm) 3. 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. | Other | Robotic hand training |
Primary outcome
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 1. Reflex Activity on paretic side (2 items) Bicep reflex Tricep reflex 2. Volitional movements within synergies pattern Flexion synergy ,Extensor synergy 3. Volitional movement mixing synergies 4. 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
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
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
1 secondary outcome
Modified ashworth scale (MAS)
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayesha Umer, MS-NMPT* principal investigator
Riphah International Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental imagery training combined with Robotic hand training and Robotic hand training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arshad Nawaz Malik, PhD Rehab (03334503754, arshad.nawaz@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment Upper Extremity (FMA-UE). (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.