StrokeNCT07282938
Combined Effects of Soft Robotic Hand and Electrical Stimulation on Hand Function in Stroke Survivors
A study testing Soft Robotic Hand combined with Neuromuscular Electrical Stimulation along with Task Oriented Training and Neuromuscular Electrical Stimulation along with Task Oriented Training in people with Stroke and Cerebro-vascular Accident, run by Lahore University of Biological and Applied Sciences at 2 sites in Pakistan.
Trial summary
Stroke is a clinically delineated syndrome, which is characterised by an acute, focal neurological deficit resulting from vascular injury (infarction or haemorrhage) within the central nervous system. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke, Cerebro-vascular Accident
- What is being tested?
- Soft Robotic Hand combined with Neuromuscular Electrical Stimulation along with Task Oriented Training and Neuromuscular Electrical Stimulation along with Task Oriented Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesPakistan
- Study dates
- 8 Dec 2025to Jun 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with their first episode of stroke.
- Participants with 3-6 months post stroke.
- Participants with normal cognition on Montreal Cognitive Assessment (MOCA) ≥24.
- Participants with the ability to extend Metacarpophalangeal (MCP) and Proximal Interphalangeal (PIP) joint to 180 degree passively
- Modified Ashworth Scale < 2.
- Participants with the score of 10 to 16 on National Institute of Health Stroke Scale Score (NIHSS Score).
Who cannot join
- Presence of other neurological, neuromuscular, orthopedic diseases, or
- conditions that may interfere with task performance.
- Participants with sensory disturbances in the fingers
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Pakistan Society for the Rehabilitation of the Disabled (PSRD)
Lahore, Punjab Province, 54660
- Recruiting
Shadman Medical Center, Stroke Rehabilitation
Lahore, Punjab Province, 54660
About this study
Stroke is a clinically delineated syndrome, which is characterised by an acute, focal neurological deficit resulting from vascular injury (infarction or haemorrhage) within the central nervous system. Notably, around 80 percent of stroke survivors experience post-stroke deficits in upper extremity (UE) motor performance, impacting grip strength, dexterity, and functional independence, which greatly hinder the ability of stroke patients to carry out activities of daily living (ADL), and in turn affects their overall quality of life (QOL).One potential solution to these difficulties is the creation of rehabilitation robotic devices that incorporate hand technology and electrical stimulation. Although soft robotic assistive devices and electrical stimulation have each shown positive effects on motor recovery, their combined use has yet to be thoroughly investigated. This study intends to determine if the simultaneous application of these therapies can speed up rehabilitation results in comparison to independent therapies. Stroke Participants will be divided into two groups, Experimental group and Control group. Both the groups will receive intervention for 40 min/day, 03 days/week, for 08 week and measurements will be taken prior to the treatment, after 4 weeks of treatment and 8 weeks post-treatment.
Read the detailed description
Stroke is the second largest cause of death and disability worldwide. On the basis of cause, there are two major kinds of strokes, 80 % of which are ischemic strokes and 20% are of hemorrhagic stroke. While on the basis of duration stroke is divided as transient ischemic stroke (TIA), acute, sub-acute and chronic stroke. Between 1993/1994 and 2005, the mean age of stroke onset decreased by two years, and the proportion of strokes among individuals aged 20 to 54 increased by approximately 50%, from 12.9% to 18.6%, with ischemic stroke being the most common type. Prevalence of stroke in low-income countries is increasing over the last three decades with an annual increase of 14.3%, and globally, the overall prevalence of stroke in the elderly is estimated at 7.4%. Between 17% and 40% of stroke survivors experience spasticity in their upper extremities, significantly impairing their ability to perform daily tasks. Rehabilitation of the upper limbs is particularly crucial during the first six months following a stroke, as recovery of motor functions and daily living activities significantly diminishes after this period. Beyond this six-month window, up to 66% of patients fail to regain functional upper-limb capabilities. Robot assisted therapy (RAT) is a novel approach used in the stroke rehabilitation to deliver the motor and task-oriented training by utilizing robotic devices. There are many researches working on the effect of soft robotic hand and electrical stimulation and their effect compared with the other physical therapy intervention that are constrained induced movement therapy (CIMT) or Mirror therapy or traditional physical therapy program, but the results for the combined effect of the soft robotic hand and electrical stimulation when applied along with functional task training are still under study. Given the limitations of traditional therapies, the integration of soft robotic hand with electrical stimulation may offer a promising approach to early rehabilitation. This integrated approach can enhance functional recovery by facilitating neuroplasticity and motor relearning through synchronised passive and active movements, thereby promoting greater independence in daily activities. This research aims to develop effective rehabilitation strategies that lower long-term healthcare costs and enhance overall motor recovery.
- Conditions
- Stroke, Cerebro-vascular Accident
- Being tested
- Soft Robotic Hand combined with Neuromuscular Electrical Stimulation along with Task Oriented Training, Neuromuscular Electrical Stimulation along with Task Oriented Training
- Keywords
- Stroke, hand impairments, soft robotic hand, electrical stimulation, robotic therapy, Cerebrovascular accident
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Robotic Hand combined with Neuromuscular Electrical Stimulation along with Task Oriented TrainingOther
Also called Soft Robotic Hand, robotic assisted therapy, electrical stimulation, soft robotic hand and electrical stimulation
Group-1, will follow a rehabilitation program that combines soft robotic hand support, electrical muscle stimulation (EMS), and task oriented training. After the adjustment of soft robotic hand, EMS electrodes will be placed on specific muscles, with set FITT principal as, A pulse frequency of 20 to 50 Hz and a pulse duration of 400 μs will be set with the intensity as per tolerated by the participant. Participants will perform task oriented activities that will include, Reaching to grasp objects, Picking up and releasing things at different heights using active finger and wrist extension. Opening a jar, or bottle, Turning a key or doorknob, Holding and lifting a tray or flat object, Pushing objects forward (like sliding a book across) with the assistance of soft robotic hand while electrical simulations are being delivered through the EMS for 40 min/day, 03 days/week, for 08 week. Measurements will be taken prior to the treatment, after 4 weeks of treatment and 8 weeks post-treatment.
Neuromuscular Electrical Stimulation along with Task Oriented TrainingOther
Also called Electrical stimulation, Neuromuscular electrical stimulation, task oriented training
The control group will follow a rehabilitation program that combines support of electrical stimulation, and task oriented training. For the stimulation of muscles ComfyStim EMS device will be used. The FITT principal used for EMS will be as, A pulse frequency of 20 to 50 Hz and a pulse duration of 400 μs will be set with the intensity as per tolerated by the participant. Participants will perform task oriented activities that will include, Reaching to grasp objects, Picking up and releasing things at different heights using active finger and wrist extension. Opening a jar or bottle, Turning a key or doorknob, Holding and lifting a tray or flat object, Pushing objects forward (like sliding a book across) while electrical simulations are being delivered through the EMS for 40 min/day, 03 days/week, for 08 week. Measurements will be taken prior to the treatment, after 4 weeks of treatment and 8 weeks post-treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group-1 (Soft Robotic Hand + Neuromuscular Electrical Stimulation) | Experimental | The experimental group will follow a rehabilitation program that combines soft robotic hand support along with electrical muscle stimulation (EMS), and perform task oriented training. Syrebo Hand rehabilitation robotic glove will be used which help the patient to flex and extend the fingers as in open or close a fist and for the stimulation of muscles ComfyStim EMS device will be used, By placing EMS electrodes on the important muscle groups used for gripping, moving the wrist, and making small movements, adjusting the intensity to what each person can handle. After the careful set up of both devices patient will perform task training such as grip-release cycles, reaching to grab objects, pinching small items, and mimicking daily activities like lifting a cup or stacking blocks. Receives: Other: Soft Robotic Hand combined with Neuromuscular Electrical Stimulation along with Task Oriented Training |
| Control: Group-2 ( Neuromuscular Electrical Stimulation) | Other | The control group will follow a rehabilitation program that combines support of electrical stimulation, and task oriented training. For the stimulation of muscles ComfyStim EMS device will be used, by placing EMS electrodes on the important muscle groups used for gripping, moving the wrist, and making small movements, adjusting the intensity to what each person can handle. After the careful set up of EMS device patient will perform task training such as grip-release cycles, reaching to grab objects, pinching small items, and mimicking daily activities like lifting a cup or stacking blocks. Receives: Other: Neuromuscular Electrical Stimulation along with Task Oriented Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
Motor hand function will be assessed using the Wolf Motor Function Test (WMFT). The WMFT evaluates functional ability and movement speed through 17 tasks, including 15 timed functional tasks and 2 strength-based tasks. Each task is scored on a 6-point scale (0-5), with higher scores indicating better performance; total scores range from 0 to 85.
Measured: Measurements will be taken before the treatment as baseline, after 4 weeks of treatment, and 8 weeks post-treatment
Fugl-meyer assessment of upper limb (FMA-UE)
Motor hand function will be assessed using the Fugl-Meyer Assessment of Upper Extremity (FMA-UE). The FMA-UE has demonstrated excellent test-retest and inter- and intra-rater reliability, and evidence for its content validity. The FMA assesses motor recovery in the upper extremity using a 33-item scale scored from 0 to 2 per item, with a maximum score of 66.
Measured: Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
Nine-Peg Hole Test
Dexterity of the affected hand will be assessed using the Nine-Hole Peg Test (NHPT), a standardized and widely used tool for measuring fine motor coordination. Participants are instructed to place nine pegs into nine holes on a board and then remove them as quickly as possible, using one hand at a time. The total time taken to complete the task is recorded in seconds. Shorter completion times indicate better manual dexterity.
Measured: Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
Dynamometer
Grip strength will be assessed using a hand-held dynamometer, a reliable tool for measuring isometric muscle force. Participants will be instructed to squeeze the device with maximum effort while seated, with the elbow flexed at 90 degrees and the forearm in a neutral position. Each hand will be tested three times, and the highest value will be recorded. This method provides an objective measure of hand strength and is commonly used in stroke rehabilitation to monitor functional recovery and response to intervention.
Measured: Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
Modified Ashworth Scale
The Modified Ashworth Scale (MAS) will be used to evaluate muscle spasticity in the affected upper limb. This scale grades resistance during passive soft-tissue stretching on a 6-point ordinal scale (0 to 4, with an additional 1+ grade), where higher scores indicate increased muscle tone. MAS is widely used in stroke rehabilitation to monitor changes in spasticity and assess the effectiveness of interventions aimed at promoting motor recovery.
Measured: Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start8 Dec 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Lahore University of Biological and Applied SciencesThe sponsor's other registered studies.
- 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
- Model description
- After recruitment, the participants will be allocated into their respective groups utilizing the online randomizer tool.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD, Principal investigator, Lahore University of Biological and Applied sciences, UBAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282938
- Sponsor's protocol ID
- UBAS/ERB/FoRS/25/040 Amna
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kristensen MGH, Busk H, Wienecke T. Neuromuscular Electrical Stimulation Improves Activities of Daily Living Post Stroke: A Systematic Review and Meta-analysis. Arch Rehabil Res Clin Transl. 2021 Nov 12;4(1):100167. doi: 10.1016/j.arrct.2021.100167. eCollection 2022 Mar.
PubMed 35282150Ko MJ, Chuang YC, Ou-Yang LJ, Cheng YY, Tsai YL, Lee YC. The Application of Soft Robotic Gloves in Stroke Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Brain Sci. 2023 Jun 2;13(6):900. doi: 10.3390/brainsci13060900.
PubMed 37371378Bayindir O, Akyuz G, Sekban N. The effect of adding robot-assisted hand rehabilitation to conventional rehabilitation program following stroke: A randomized-controlled study. Turk J Phys Med Rehabil. 2022 Jun 1;68(2):254-261. doi: 10.5606/tftrd.2022.8705. eCollection 2022 Jun.
PubMed 35989963Chen P, Liu TW, Tse MMY, Lai CKY, Tsoh J, Ng SSM. The Predictive Role of Hand Section of Fugl-Meyer Assessment and Motor Activity Log in Action Research Arm Test in People With Stroke. Front Neurol. 2022 Jul 7;13:926130. doi: 10.3389/fneur.2022.926130. eCollection 2022.
PubMed 35873769Chien WT, Chong YY, Tse MK, Chien CW, Cheng HY. Robot-assisted therapy for upper-limb rehabilitation in subacute stroke patients: A systematic review and meta-analysis. Brain Behav. 2020 Aug;10(8):e01742. doi: 10.1002/brb3.1742. Epub 2020 Jun 26.
PubMed 32592282Lindsay LR, Thompson DA, O'Dell MW. Updated Approach to Stroke Rehabilitation. Med Clin North Am. 2020 Mar;104(2):199-211. doi: 10.1016/j.mcna.2019.11.002.
PubMed 32035564Mosconi MG, Paciaroni M. Treatments in Ischemic Stroke: Current and Future. Eur Neurol. 2022;85(5):349-366. doi: 10.1159/000525822. Epub 2022 Aug 2.
PubMed 35917794Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.
PubMed 32837228
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Soft Robotic Hand and Electrical Stimulation on Hand Function in Stroke Survivors
- ClinicalTrials.gov ID
- NCT07282938
- Acronym / sponsor ID
- UBAS/ERB/FoRS/25/040 Amna
- Conditions
- Stroke, Cerebro-vascular Accident
- Keywords
- Stroke, hand impairments, soft robotic hand, electrical stimulation, robotic therapy, Cerebrovascular accident
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Dec 2025 (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.
Stroke is a clinically delineated syndrome, which is characterised by an acute, focal neurological deficit resulting from vascular injury (infarction or haemorrhage) within the central nervous system. Notably, around 80 percent of stroke survivors experience post-stroke deficits in upper extremity (UE) motor performance, impacting grip strength, dexterity, and functional independence, which greatly hinder the ability of stroke patients to carry out activities of daily living (ADL), and in turn affects their overall quality of life (QOL).One potential solution to these difficulties is the creation of rehabilitation robotic devices that incorporate hand technology and electrical stimulation. Although soft robotic assistive devices and electrical stimulation have each shown positive effects on motor recovery, their combined use has yet to be thoroughly investigated. This study intends to determine if the simultaneous application of these therapies can speed up rehabilitation results in comparison to independent therapies. Stroke Participants will be divided into two groups, Experimental group and Control group. Both the groups will receive intervention for 40 min/day, 03 days/week, for 08 week and measurements will be taken prior to the treatment, after 4 weeks of treatment and 8 weeks post-treatment.
Detailed description
Stroke is the second largest cause of death and disability worldwide. On the basis of cause, there are two major kinds of strokes, 80 % of which are ischemic strokes and 20% are of hemorrhagic stroke. While on the basis of duration stroke is divided as transient ischemic stroke (TIA), acute, sub-acute and chronic stroke. Between 1993/1994 and 2005, the mean age of stroke onset decreased by two years, and the proportion of strokes among individuals aged 20 to 54 increased by approximately 50%, from 12.9% to 18.6%, with ischemic stroke being the most common type. Prevalence of stroke in low-income countries is increasing over the last three decades with an annual increase of 14.3%, and globally, the overall prevalence of stroke in the elderly is estimated at 7.4%. Between 17% and 40% of stroke survivors experience spasticity in their upper extremities, significantly impairing their ability to perform daily tasks. Rehabilitation of the upper limbs is particularly crucial during the first six months following a stroke, as recovery of motor functions and daily living activities significantly diminishes after this period. Beyond this six-month window, up to 66% of patients fail to regain functional upper-limb capabilities. Robot assisted therapy (RAT) is a novel approach used in the stroke rehabilitation to deliver the motor and task-oriented training by utilizing robotic devices. There are many researches working on the effect of soft robotic hand and electrical stimulation and their effect compared with the other physical therapy intervention that are constrained induced movement therapy (CIMT) or Mirror therapy or traditional physical therapy program, but the results for the combined effect of the soft robotic hand and electrical stimulation when applied along with functional task training are still under study. Given the limitations of traditional therapies, the integration of soft robotic hand with electrical stimulation may offer a promising approach to early rehabilitation. This integrated approach can enhance functional recovery by facilitating neuroplasticity and motor relearning through synchronised passive and active movements, thereby promoting greater independence in daily activities. This research aims to develop effective rehabilitation strategies that lower long-term healthcare costs and enhance overall motor recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- After recruitment, the participants will be allocated into their respective groups utilizing the online randomizer tool.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group-1 (Soft Robotic Hand + Neuromuscular Electrical Stimulation) | Experimental | Other: Soft Robotic Hand combined with Neuromuscular Electrical Stimulation along with Task Oriented TrainingThe experimental group will follow a rehabilitation program that combines soft robotic hand support along with electrical muscle stimulation (EMS), and perform task oriented training. Syrebo Hand rehabilitation robotic glove will be used which help the patient to flex and extend the fingers as in open or close a fist and for the stimulation of muscles ComfyStim EMS device will be used, By placing EMS electrodes on the important muscle groups used for gripping, moving the wrist, and making small movements, adjusting the intensity to what each person can handle. After the careful set up of both devices patient will perform task training such as grip-release cycles, reaching to grab objects, pinching small items, and mimicking daily activities like lifting a cup or stacking blocks. |
| Control: Group-2 ( Neuromuscular Electrical Stimulation) | Other | Other: Neuromuscular Electrical Stimulation along with Task Oriented TrainingThe control group will follow a rehabilitation program that combines support of electrical stimulation, and task oriented training. For the stimulation of muscles ComfyStim EMS device will be used, by placing EMS electrodes on the important muscle groups used for gripping, moving the wrist, and making small movements, adjusting the intensity to what each person can handle. After the careful set up of EMS device patient will perform task training such as grip-release cycles, reaching to grab objects, pinching small items, and mimicking daily activities like lifting a cup or stacking blocks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with their first episode of stroke.
- Participants with 3-6 months post stroke.
- Participants with normal cognition on Montreal Cognitive Assessment (MOCA) ≥24.
- Participants with the ability to extend Metacarpophalangeal (MCP) and Proximal Interphalangeal (PIP) joint to 180 degree passively
- Modified Ashworth Scale < 2.
Key exclusion criteria (3 listed)
- Presence of other neurological, neuromuscular, orthopedic diseases, or
- conditions that may interfere with task performance.
- Participants with sensory disturbances in the fingers
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 |
|---|---|---|
| Soft Robotic Hand combined with Neuromuscular Electrical Stimulation along with Task Oriented TrainingAlso: Soft Robotic Hand, robotic assisted therapy, electrical stimulation, soft robotic hand and electrical stimulationGroup-1, will follow a rehabilitation program that combines soft robotic hand support, electrical muscle stimulation (EMS), and task oriented training. After the adjustment of soft robotic hand, EMS electrodes will be placed on specific muscles, with set FITT principal as, A pulse frequency of 20 to 50 Hz and a pulse duration of 400 μs will be set with the intensity as per tolerated by the participant. Participants will perform task oriented activities that will include, Reaching to grasp objects, Picking up and releasing things at different heights using active finger and wrist extension. Opening a jar, or bottle, Turning a key or doorknob, Holding and lifting a tray or flat object, Pushing objects forward (like sliding a book across) with the assistance of soft robotic hand while electrical simulations are being delivered through the EMS for 40 min/day, 03 days/week, for 08 week. Measurements will be taken prior to the treatment, after 4 weeks of treatment and 8 weeks post-treatment. | Other | Experimental: Group-1 (Soft Robotic Hand + Neuromuscular Electrical Stimulation) |
| Neuromuscular Electrical Stimulation along with Task Oriented TrainingAlso: Electrical stimulation, Neuromuscular electrical stimulation, task oriented trainingThe control group will follow a rehabilitation program that combines support of electrical stimulation, and task oriented training. For the stimulation of muscles ComfyStim EMS device will be used. The FITT principal used for EMS will be as, A pulse frequency of 20 to 50 Hz and a pulse duration of 400 μs will be set with the intensity as per tolerated by the participant. Participants will perform task oriented activities that will include, Reaching to grasp objects, Picking up and releasing things at different heights using active finger and wrist extension. Opening a jar or bottle, Turning a key or doorknob, Holding and lifting a tray or flat object, Pushing objects forward (like sliding a book across) while electrical simulations are being delivered through the EMS for 40 min/day, 03 days/week, for 08 week. Measurements will be taken prior to the treatment, after 4 weeks of treatment and 8 weeks post-treatment. | Other | Control: Group-2 ( Neuromuscular Electrical Stimulation) |
Primary outcome
Wolf Motor Function Test
Time frame: Measurements will be taken before the treatment as baseline, after 4 weeks of treatment, and 8 weeks post-treatment
Motor hand function will be assessed using the Wolf Motor Function Test (WMFT). The WMFT evaluates functional ability and movement speed through 17 tasks, including 15 timed functional tasks and 2 strength-based tasks. Each task is scored on a 6-point scale (0-5), with higher scores indicating better performance; total scores range from 0 to 85.
Fugl-meyer assessment of upper limb (FMA-UE)
Time frame: Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
Motor hand function will be assessed using the Fugl-Meyer Assessment of Upper Extremity (FMA-UE). The FMA-UE has demonstrated excellent test-retest and inter- and intra-rater reliability, and evidence for its content validity. The FMA assesses motor recovery in the upper extremity using a 33-item scale scored from 0 to 2 per item, with a maximum score of 66.
Nine-Peg Hole Test
Time frame: Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
Dexterity of the affected hand will be assessed using the Nine-Hole Peg Test (NHPT), a standardized and widely used tool for measuring fine motor coordination. Participants are instructed to place nine pegs into nine holes on a board and then remove them as quickly as possible, using one hand at a time. The total time taken to complete the task is recorded in seconds. Shorter completion times indicate better manual dexterity.
Dynamometer
Time frame: Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
Grip strength will be assessed using a hand-held dynamometer, a reliable tool for measuring isometric muscle force. Participants will be instructed to squeeze the device with maximum effort while seated, with the elbow flexed at 90 degrees and the forearm in a neutral position. Each hand will be tested three times, and the highest value will be recorded. This method provides an objective measure of hand strength and is commonly used in stroke rehabilitation to monitor functional recovery and response to intervention.
Modified Ashworth Scale
Time frame: Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment.
The Modified Ashworth Scale (MAS) will be used to evaluate muscle spasticity in the affected upper limb. This scale grades resistance during passive soft-tissue stretching on a 6-point ordinal scale (0 to 4, with an additional 1+ grade), where higher scores indicate increased muscle tone. MAS is widely used in stroke rehabilitation to monitor changes in spasticity and assess the effectiveness of interventions aimed at promoting motor recovery.
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 18 Jun 2026.
- Background: PubMed 35282150Kristensen MGH, Busk H, Wienecke T. Neuromuscular Electrical Stimulation Improves Activities of Daily Living Post Stroke: A Systematic Review and Meta-analysis. Arch Rehabil Res Clin Transl. 2021 Nov 12;4(1):100167. doi: 10.1016/j.arrct.2021.100167. eCollection 2022 Mar.
- Background: PubMed 37371378Ko MJ, Chuang YC, Ou-Yang LJ, Cheng YY, Tsai YL, Lee YC. The Application of Soft Robotic Gloves in Stroke Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Brain Sci. 2023 Jun 2;13(6):900. doi: 10.3390/brainsci13060900.
- Background: PubMed 35989963Bayindir O, Akyuz G, Sekban N. The effect of adding robot-assisted hand rehabilitation to conventional rehabilitation program following stroke: A randomized-controlled study. Turk J Phys Med Rehabil. 2022 Jun 1;68(2):254-261. doi: 10.5606/tftrd.2022.8705. eCollection 2022 Jun.
- Background: PubMed 35873769Chen P, Liu TW, Tse MMY, Lai CKY, Tsoh J, Ng SSM. The Predictive Role of Hand Section of Fugl-Meyer Assessment and Motor Activity Log in Action Research Arm Test in People With Stroke. Front Neurol. 2022 Jul 7;13:926130. doi: 10.3389/fneur.2022.926130. eCollection 2022.
- Background: PubMed 32592282Chien WT, Chong YY, Tse MK, Chien CW, Cheng HY. Robot-assisted therapy for upper-limb rehabilitation in subacute stroke patients: A systematic review and meta-analysis. Brain Behav. 2020 Aug;10(8):e01742. doi: 10.1002/brb3.1742. Epub 2020 Jun 26.
- Background: PubMed 32035564Lindsay LR, Thompson DA, O'Dell MW. Updated Approach to Stroke Rehabilitation. Med Clin North Am. 2020 Mar;104(2):199-211. doi: 10.1016/j.mcna.2019.11.002.
- Background: PubMed 35917794Mosconi MG, Paciaroni M. Treatments in Ischemic Stroke: Current and Future. Eur Neurol. 2022;85(5):349-366. doi: 10.1159/000525822. Epub 2022 Aug 2.
- Background: PubMed 32837228Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.
- 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.
Aruba Saeed, PhD principal investigator
Lahore University of Biological and Applied sciences, UBAS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft Robotic Hand combined with Neuromuscular Electrical Stimulation along with Task Oriented Training and Neuromuscular Electrical Stimulation along with Task Oriented Training in people with Stroke and Cerebro-vascular Accident, run by Lahore University of Biological and Applied Sciences at 2 sites 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 6 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 18 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 2 sites 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 Amna Naveed, DPT (+923178731632, amnanaveed14082000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (time frame: Measurements will be taken before the treatment as baseline, after 4 weeks of treatment, and 8 weeks post-treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07282938, which also lists 8 linked publications.
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 18 Jun 2026.