StrokeNCT07160114
Task-oriented Training With Electrical Stimulation Glove on Hand Function and Dexterity in Chronic Stroke Patients
A study testing Electrical Stimulation Glove with Task-Oriented Training and Task-Oriented Training Only in people with Stroke and Chronic Stroke Patient, run by University of Lahore at 1 site in Pakistan.
Trial summary
Stroke often causes long-lasting weakness and difficulty using the hands, which limits independence in daily life. Many patients find it hard to perform everyday tasks such as dressing, eating, or writing. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke, Chronic Stroke Patient
- What is being tested?
- Electrical Stimulation Glove with Task-Oriented Training and Task-Oriented Training Only
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2025to 28 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients after the six months of first stroke event (chronic stroke patient)
- Mini mental scale grade (24/above)
- Medically and neurologically stable condition
- No visual or auditory defects (Anderson \& White, 2023)
Who cannot join
- Pre-existing arm impairment such as rheumatoid arthritis
- Cardiac pacemaker
- Patients with other neurological impairments
- Recurrent or progressive stroke
- Unconscious patients due to any other cause
- History of seizure within 2 years (Anderson \& White, 2023)
Trial locations and contacts
1 site in 1 country.
About this study
Stroke often causes long-lasting weakness and difficulty using the hands, which limits independence in daily life. Many patients find it hard to perform everyday tasks such as dressing, eating, or writing. Rehabilitation usually includes task-oriented training (TOT), which means practicing meaningful activities that mimic real-life situations.
This study is testing whether adding a new device called an electrical stimulation glove (ESG) can make hand training more effective for people living with chronic stroke. The glove delivers gentle electrical impulses to the muscles in the hand while patients practice functional tasks. This stimulation may help activate weak muscles and improve coordination during rehabilitation.
Read more
Participants in this study are divided into two groups:
One group receives task-oriented training with the electrical stimulation glove,
The other group receives task-oriented training only.
Therapy includes warm-up exercises, task practice such as pegboard activities, grasping and releasing objects, and everyday skills, followed by cool-down exercises.
The study is being carried out at CMH Multan, Pakistan, and involves adult men and women between 40 and 60 years of age who have experienced a stroke more than six months earlier. Outcomes are measured with standard rehabilitation tools that assess hand function, motor recovery, and dexterity.
This research may help determine whether the electrical stimulation glove can be used alongside routine rehabilitation programs to support better recovery of hand function in people with stroke.
Read the detailed description
Background and Rationale Stroke is a major cause of long-term disability worldwide. Many stroke survivors experience chronic upper limb impairment, including weakness, stiffness, and reduced dexterity, which limits their ability to perform daily activities. Task-oriented training is a widely used rehabilitation approach that focuses on practicing functional, goal-directed movements to restore independence. Electrical stimulation has also been shown to support neuromuscular activation and promote neuroplasticity. Integrating these two strategies into a single wearable device - an electrical stimulation glove (ESG) - may offer a novel and affordable rehabilitation option.
Study Objectives The purpose of this trial is to evaluate the effects of combining task-oriented training with an electrical stimulation glove on hand function and dexterity in chronic stroke patients, compared to task-oriented training alone.
Study Design
This is a randomized controlled trial conducted at CMH Multan, Pakistan, over nine months. A total of 36 participants are enrolled, with 18 in each group. Patients are randomly assigned to either:
Intervention Group: Task-oriented training with an electrical stimulation glove.
Control Group: Task-oriented training only.
Eligibility Participants are men and women aged 40-60 years, at least six months after their first stroke, medically stable, and with adequate cognitive ability (Mini-Mental Scale score ≥24). Patients with recurrent stroke, seizures, pacemakers, or other neurological/orthopedic impairments are excluded.
Interventions
Task-Oriented Training (Control): Sessions include warm-up exercises, functional tasks such as pegboard placement, grasp-and-release of objects, writing or drawing, and simulated daily activities, followed by cool-down stretches.
Task-Oriented Training with Electrical Stimulation Glove (Intervention): Same activities as above, but performed while wearing the ESG. The glove delivers gentle electrical impulses to wrist and finger muscles during task performance, supporting active movement and sensory feedback.
Each session lasts approximately 60 minutes, including warm-up, 40 minutes of functional activities, and cool-down. The program runs three times per week for eight weeks.
Outcome Measures
Hand function and dexterity are evaluated before and after the intervention using standardized tools:
Wolf Functional Test (WFT): assesses the quality and speed of upper limb tasks.
Fugl-Meyer Assessment - Upper Extremity (FMA-U): evaluates motor recovery of the arm and hand.
Functional Dexterity Test (FDT): measures fine motor control and coordination.
Ethical Considerations Informed consent is obtained from all participants. Confidentiality and safety are maintained throughout the study. Participation is voluntary, and individuals may withdraw at any time without penalty.
- Conditions
- Stroke, Chronic Stroke Patient
- Being tested
- Electrical Stimulation Glove with Task-Oriented Training, Task-Oriented Training Only
- Keywords
- Stroke rehabilitation, Electrical stimulation glove, Task-oriented training, Upper extremity function, Hand dexterity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Stimulation Glove with Task-Oriented TrainingDevice
Participants perform structured task-oriented training while wearing an electrical stimulation glove. The glove is embedded with electrodes that deliver low-intensity electrical impulses to the wrist and finger muscles during functional tasks. Training includes warm-up range of motion and stretching, 40 minutes of functional activities such as pegboard tasks, object manipulation, writing, and daily living tasks, followed by cool-down exercises. The intervention is delivered in 60-minute sessions, three times per week, for 8 weeks.
Task-Oriented Training OnlyBehavioural
Participants receive task-oriented training without the electrical stimulation glove. Training includes warm-up range of motion and stretching, 40 minutes of functional activities such as pegboard placement, grasp-and-release, writing or drawing, and simulated daily living tasks, followed by cool-down exercises. The intervention is delivered in 60-minute sessions, three times per week, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Task-Oriented Training with Electrical Stimulation Glove | Experimental | Participants receive task-oriented training combined with an electrical stimulation glove. Sessions include warm-up exercises, functional activities (such as pegboard tasks, grasp-and-release of objects, writing, and simulated daily activities), and cool-down stretches. The glove delivers low-intensity electrical impulses to the wrist and finger muscles during training to facilitate neuromuscular activation and enhance motor recovery. Sessions last approximately 60 minutes, three times per week for 8 weeks. Receives: Device: Electrical Stimulation Glove with Task-Oriented Training |
| Task-Oriented Training Only | Active comparator | Participants receive task-oriented training without the electrical stimulation glove. Sessions include warm-up exercises, functional activities (such as pegboard placement, grasp-and-release of objects, writing or drawing, and simulated daily activities), and cool-down stretches. This protocol provides standard rehabilitation focusing on functional use of the affected hand. Sessions last approximately 60 minutes, three times per week for 8 weeks. Receives: Behavioral: Task-Oriented Training Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Extremity Motor Function (Fugl-Meyer Assessment - Upper Extremity, FMA-U)
The Fugl-Meyer Assessment - Upper Extremity is a stroke-specific, performance-based scale that evaluates motor function, balance, sensation, and joint functioning. In this study, it is used to assess changes in upper limb motor recovery after intervention.
Measured: Baseline and 8 weeks post-intervention
Secondary outcomes (2)
Change in Functional Performance (Wolf Functional Test, WFT)
The Wolf Functional Test assesses upper extremity motor ability through timed and functional tasks such as lifting, reaching, and manipulating objects. It measures speed and quality of movement in stroke patients.
Measured: Baseline and 8 weeks post-intervention
Change in Hand Dexterity (Functional Dexterity Test, FDT)
The Functional Dexterity Test evaluates fine motor control, coordination, and speed of finger movements required for daily activities. Lower scores reflect better dexterity.
Measured: Baseline and 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start15 Apr 2025
- Primary completion19 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha waris, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160114
- Sponsor's protocol ID
- UOL/IREB/25/09/0031
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ackerley SJ, Byblow WD, Barber PA, MacDonald H, McIntyre-Robinson A, Stinear CM. Primed Physical Therapy Enhances Recovery of Upper Limb Function in Chronic Stroke Patients. Neurorehabil Neural Repair. 2016 May;30(4):339-48. doi: 10.1177/1545968315595285. Epub 2015 Jul 15.
PubMed 26180053Abo M, Kakuda W, Momosaki R, Harashima H, Kojima M, Watanabe S, Sato T, Yokoi A, Umemori T, Sasanuma J. Randomized, multicenter, comparative study of NEURO versus CIMT in poststroke patients with upper limb hemiparesis: the NEURO-VERIFY Study. Int J Stroke. 2014 Jul;9(5):607-12. doi: 10.1111/ijs.12100. Epub 2013 Sep 9.
PubMed 24015934
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-oriented Training With Electrical Stimulation Glove on Hand Function and Dexterity in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT07160114
- Acronym / sponsor ID
- UOL/IREB/25/09/0031
- Conditions
- Stroke, Chronic Stroke Patient
- Keywords
- Stroke rehabilitation, Electrical stimulation glove, Task-oriented training, Upper extremity function, Hand dexterity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 8 Sep 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 often causes long-lasting weakness and difficulty using the hands, which limits independence in daily life. Many patients find it hard to perform everyday tasks such as dressing, eating, or writing. Rehabilitation usually includes task-oriented training (TOT), which means practicing meaningful activities that mimic real-life situations.
This study is testing whether adding a new device called an electrical stimulation glove (ESG) can make hand training more effective for people living with chronic stroke. The glove delivers gentle electrical impulses to the muscles in the hand while patients practice functional tasks. This stimulation may help activate weak muscles and improve coordination during rehabilitation.
Participants in this study are divided into two groups:
One group receives task-oriented training with the electrical stimulation glove,
The other group receives task-oriented training only.
Therapy includes warm-up exercises, task practice such as pegboard activities, grasping and releasing objects, and everyday skills, followed by cool-down exercises.
The study is being carried out at CMH Multan, Pakistan, and involves adult men and women between 40 and 60 years of age who have experienced a stroke more than six months earlier. Outcomes are measured with standard rehabilitation tools that assess hand function, motor recovery, and dexterity.
This research may help determine whether the electrical stimulation glove can be used alongside routine rehabilitation programs to support better recovery of hand function in people with stroke.
Detailed description
Background and Rationale Stroke is a major cause of long-term disability worldwide. Many stroke survivors experience chronic upper limb impairment, including weakness, stiffness, and reduced dexterity, which limits their ability to perform daily activities. Task-oriented training is a widely used rehabilitation approach that focuses on practicing functional, goal-directed movements to restore independence. Electrical stimulation has also been shown to support neuromuscular activation and promote neuroplasticity. Integrating these two strategies into a single wearable device - an electrical stimulation glove (ESG) - may offer a novel and affordable rehabilitation option.
Study Objectives The purpose of this trial is to evaluate the effects of combining task-oriented training with an electrical stimulation glove on hand function and dexterity in chronic stroke patients, compared to task-oriented training alone.
Study Design
This is a randomized controlled trial conducted at CMH Multan, Pakistan, over nine months. A total of 36 participants are enrolled, with 18 in each group. Patients are randomly assigned to either:
Intervention Group: Task-oriented training with an electrical stimulation glove.
Control Group: Task-oriented training only.
Eligibility Participants are men and women aged 40-60 years, at least six months after their first stroke, medically stable, and with adequate cognitive ability (Mini-Mental Scale score ≥24). Patients with recurrent stroke, seizures, pacemakers, or other neurological/orthopedic impairments are excluded.
Interventions
Task-Oriented Training (Control): Sessions include warm-up exercises, functional tasks such as pegboard placement, grasp-and-release of objects, writing or drawing, and simulated daily activities, followed by cool-down stretches.
Task-Oriented Training with Electrical Stimulation Glove (Intervention): Same activities as above, but performed while wearing the ESG. The glove delivers gentle electrical impulses to wrist and finger muscles during task performance, supporting active movement and sensory feedback.
Each session lasts approximately 60 minutes, including warm-up, 40 minutes of functional activities, and cool-down. The program runs three times per week for eight weeks.
Outcome Measures
Hand function and dexterity are evaluated before and after the intervention using standardized tools:
Wolf Functional Test (WFT): assesses the quality and speed of upper limb tasks.
Fugl-Meyer Assessment - Upper Extremity (FMA-U): evaluates motor recovery of the arm and hand.
Functional Dexterity Test (FDT): measures fine motor control and coordination.
Ethical Considerations Informed consent is obtained from all participants. Confidentiality and safety are maintained throughout the study. Participation is voluntary, and individuals may withdraw at any time without penalty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task-Oriented Training with Electrical Stimulation Glove | Experimental | Device: Electrical Stimulation Glove with Task-Oriented TrainingParticipants receive task-oriented training combined with an electrical stimulation glove. Sessions include warm-up exercises, functional activities (such as pegboard tasks, grasp-and-release of objects, writing, and simulated daily activities), and cool-down stretches. The glove delivers low-intensity electrical impulses to the wrist and finger muscles during training to facilitate neuromuscular activation and enhance motor recovery. Sessions last approximately 60 minutes, three times per week for 8 weeks. |
| Task-Oriented Training Only | Active comparator | Behavioral: Task-Oriented Training OnlyParticipants receive task-oriented training without the electrical stimulation glove. Sessions include warm-up exercises, functional activities (such as pegboard placement, grasp-and-release of objects, writing or drawing, and simulated daily activities), and cool-down stretches. This protocol provides standard rehabilitation focusing on functional use of the affected hand. Sessions last approximately 60 minutes, three times per week for 8 weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients after the six months of first stroke event (chronic stroke patient)
- Mini mental scale grade (24/above)
- Medically and neurologically stable condition
- No visual or auditory defects (Anderson \& White, 2023)
Key exclusion criteria (6 listed)
- Pre-existing arm impairment such as rheumatoid arthritis
- Cardiac pacemaker
- Patients with other neurological impairments
- Recurrent or progressive stroke
- Unconscious patients due to any other cause
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 |
|---|---|---|
| Electrical Stimulation Glove with Task-Oriented TrainingParticipants perform structured task-oriented training while wearing an electrical stimulation glove. The glove is embedded with electrodes that deliver low-intensity electrical impulses to the wrist and finger muscles during functional tasks. Training includes warm-up range of motion and stretching, 40 minutes of functional activities such as pegboard tasks, object manipulation, writing, and daily living tasks, followed by cool-down exercises. The intervention is delivered in 60-minute sessions, three times per week, for 8 weeks. | Device | Task-Oriented Training with Electrical Stimulation Glove |
| Task-Oriented Training OnlyParticipants receive task-oriented training without the electrical stimulation glove. Training includes warm-up range of motion and stretching, 40 minutes of functional activities such as pegboard placement, grasp-and-release, writing or drawing, and simulated daily living tasks, followed by cool-down exercises. The intervention is delivered in 60-minute sessions, three times per week, for 8 weeks. | Behavioural | Task-Oriented Training Only |
Primary outcome
Change in Upper Extremity Motor Function (Fugl-Meyer Assessment - Upper Extremity, FMA-U)
Time frame: Baseline and 8 weeks post-intervention
The Fugl-Meyer Assessment - Upper Extremity is a stroke-specific, performance-based scale that evaluates motor function, balance, sensation, and joint functioning. In this study, it is used to assess changes in upper limb motor recovery after intervention.
2 secondary outcomes
Change in Functional Performance (Wolf Functional Test, WFT)
Time frame: Baseline and 8 weeks post-intervention
Change in Hand Dexterity (Functional Dexterity Test, FDT)
Time frame: Baseline and 8 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 26180053Ackerley SJ, Byblow WD, Barber PA, MacDonald H, McIntyre-Robinson A, Stinear CM. Primed Physical Therapy Enhances Recovery of Upper Limb Function in Chronic Stroke Patients. Neurorehabil Neural Repair. 2016 May;30(4):339-48. doi: 10.1177/1545968315595285. Epub 2015 Jul 15.
- Background: PubMed 24015934Abo M, Kakuda W, Momosaki R, Harashima H, Kojima M, Watanabe S, Sato T, Yokoi A, Umemori T, Sasanuma J. Randomized, multicenter, comparative study of NEURO versus CIMT in poststroke patients with upper limb hemiparesis: the NEURO-VERIFY Study. Int J Stroke. 2014 Jul;9(5):607-12. doi: 10.1111/ijs.12100. Epub 2013 Sep 9.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation Glove with Task-Oriented Training and Task-Oriented Training Only in people with Stroke and Chronic Stroke Patient, run by University of Lahore 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 8 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Extremity Motor Function (Fugl-Meyer Assessment - Upper Extremity, FMA-U) (time frame: Baseline and 8 weeks post-intervention). 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 NCT07160114, which also lists 2 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 8 Sep 2025.