StrokeNCT06739733
Effectiveness of Soft Robotic Glove Versus EMS on Hand Function and Quality of Life in Stroke Survivors (RCT)
A study testing SRG and EMS in people with Stroke, run by Superior University at 1 site in Pakistan.
Trial summary
This study will evaluate the effectiveness of soft robotic gloves versus electrical muscle stimulation (EMS) in improving hand function and quality of life in stroke survivors. Stroke often leads to impaired hand mobility, impacting daily activities and reducing overall quality of life. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- SRG and EMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 1 Mar 2025
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had ischemic or hemorrhagic stroke ≤6 months.
- Mini-mental status exam scores > 24(7).
- GCS score 11 to 15(2)
- FMA-UE score < 21(3)
Who cannot join
- Participants with severe vision or hearing impairment.
- Neurological disorders including epilepsy, Alzheimer's disease, vertigo, Parkinson disease, and , muscular disorders which limit functional activity (OA, RA, etc).
- Peripheral vestibular disorder.
- Medications that affect balance, severe cardiovascular conditions, recent lower limb injury or surgery.
- Contraindications for EMS: Patients with certain medical conditions, such as pacemakers, implantable cardioverter-defibrillators, or metal fragments in their body, that contraindicated the use of EMS were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Soft Robotic Glove Versus EMS on Hand Function and Quality of Life in Stroke Survivors. A Randomized Clinical Trial
This study will evaluate the effectiveness of soft robotic gloves versus electrical muscle stimulation (EMS) in improving hand function and quality of life in stroke survivors. Stroke often leads to impaired hand mobility, impacting daily activities and reducing overall quality of life. Soft robotic gloves, designed to assist with hand movement, will provide mechanical support and encourage voluntary muscle activity. EMS, on the other hand, will stimulate muscle contraction through electrical impulses, potentially enhancing muscle strength and coordination.
Read the detailed description
Participants will be divided into two groups: one will receive treatment using soft robotic gloves, and the other with EMS. Outcomes will be assessed using standardized hand function tests and quality-of-life questionnaires over a specified period. Results are expected to indicate that both interventions will improve hand function and quality of life, with the robotic gloves showing a marginally greater improvement in dexterity and grip strength, while EMS will yield benefits in muscle reactivation and endurance. Stroke survivors in the robotic glove group are anticipated to report greater ease in performing daily tasks, while the EMS group will note an increase in muscle engagement.
- Conditions
- Stroke
- Being tested
- SRG, EMS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRGDiagnostic test
Soft robotic gloves stimulation 30-minute sessions, 5 times per week upto 8 week Soft robotic gloves are assistive devices designed to enhance hand function for individuals with disabilities or injuries. These gloves use flexible materials, such as silicone or fabric, combined with pneumatic or cable-driven mechanisms to mimic natural hand movements. They provide assistance for gripping, holding, or manipulating objects, often controlled by sensors or user inputs. Soft robotic gloves are lightweight, adaptable, and offer rehabilitation potential, helping restore motor function in conditions like stroke or spinal cord injury. They are increasingly used in clinical and home-based therapy settings.
EMSDiagnostic test
Electrical muscle stimulation 30-minute sessions, 5 times per week upto 8 weeks.
Electrical Muscle Stimulation (EMS) is a technique that uses electrical impulses to contract muscles, often used for rehabilitation, strength training, or pain management. Electrodes placed on the skin deliver controlled currents to target specific muscle groups, mimicking natural nerve signals. EMS is commonly used in physiotherapy to prevent muscle atrophy, improve circulation, and enhance recovery after injury. It is also utilized in fitness and sports for performance enhancement. Safe and non-invasive, EMS can be adjusted for therapeutic or functional goals.
| Study group | Role | What they receive |
|---|---|---|
| SRG | Experimental | Not described Receives: Diagnostic Test: SRG |
| EMS | Active comparator | Not described Receives: Diagnostic Test: EMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fugl-Meyer Upper Extremity Assessment (FMA-UE)
The Fugl-Meyer Upper Extremity Assessment (FMA-UE) is a standardized tool used to evaluate motor function, sensation, coordination, and joint motion in individuals with upper limb impairments, often post-stroke. It is based on a hierarchical framework of motor recovery, covering movements from basic reflexes to voluntary motor control. The assessment includes various sections focusing on shoulder, elbow, forearm, wrist, hand, and coordination. Each item measures specific movement tasks, allowing therapists to track progress over time. The FMA-UE is widely used in clinical settings for its reliability and validity in evaluating upper extremity function.
Scoring
The FMA-UE has 33 items, each scored on a 3-point scale:
0 = Cannot perform
- = Partially performs
- = Fully performs
The total score ranges from 0 to 66 points (higher scores indicate better motor function).
Measured: 12 Months
The Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH)
The Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) is a shortened version of the DASH outcome measure used to assess physical function and symptoms in individuals with upper extremity conditions. It consists of 11 questions evaluating difficulty in performing daily activities, severity of symptoms (pain, tingling, weakness), and social and emotional impacts. The QuickDASH is designed for fast administration and is applicable across various musculoskeletal disorders. It provides insight into functional limitations, helping guide treatment planning.
Scoring
Each item is rated on a 1-5 Likert scale (1 = no difficulty, 5 = extreme difficulty).
Scores are averaged, transformed into a scale of 0 to 100 (0 = no disability, 100 = most severe disability).
An optional Work and Sports/Performing Arts module adds context-specific insights.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Mar 2024
- Primary completion1 Oct 2024
- Study completion1 Mar 2025 (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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739733
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/748
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Soft Robotic Glove Versus EMS on Hand Function and Quality of Life in Stroke Survivors. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06739733
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/748
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 18 Dec 2024 (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 study will evaluate the effectiveness of soft robotic gloves versus electrical muscle stimulation (EMS) in improving hand function and quality of life in stroke survivors. Stroke often leads to impaired hand mobility, impacting daily activities and reducing overall quality of life. Soft robotic gloves, designed to assist with hand movement, will provide mechanical support and encourage voluntary muscle activity. EMS, on the other hand, will stimulate muscle contraction through electrical impulses, potentially enhancing muscle strength and coordination.
Detailed description
Participants will be divided into two groups: one will receive treatment using soft robotic gloves, and the other with EMS. Outcomes will be assessed using standardized hand function tests and quality-of-life questionnaires over a specified period. Results are expected to indicate that both interventions will improve hand function and quality of life, with the robotic gloves showing a marginally greater improvement in dexterity and grip strength, while EMS will yield benefits in muscle reactivation and endurance. Stroke survivors in the robotic glove group are anticipated to report greater ease in performing daily tasks, while the EMS group will note an increase in muscle engagement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRG | Experimental | Diagnostic Test: SRG |
| EMS | Active comparator | Diagnostic Test: EMS |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Had ischemic or hemorrhagic stroke ≤6 months.
- Mini-mental status exam scores > 24(7).
- GCS score 11 to 15(2)
- FMA-UE score < 21(3)
Key exclusion criteria (5 listed)
- Participants with severe vision or hearing impairment.
- Neurological disorders including epilepsy, Alzheimer's disease, vertigo, Parkinson disease, and , muscular disorders which limit functional activity (OA, RA, etc).
- Peripheral vestibular disorder.
- Medications that affect balance, severe cardiovascular conditions, recent lower limb injury or surgery.
- Contraindications for EMS: Patients with certain medical conditions, such as pacemakers, implantable cardioverter-defibrillators, or metal fragments in their body, that contraindicated the use of EMS were excluded.
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 |
|---|---|---|
| SRGSoft robotic gloves stimulation 30-minute sessions, 5 times per week upto 8 week Soft robotic gloves are assistive devices designed to enhance hand function for individuals with disabilities or injuries. These gloves use flexible materials, such as silicone or fabric, combined with pneumatic or cable-driven mechanisms to mimic natural hand movements. They provide assistance for gripping, holding, or manipulating objects, often controlled by sensors or user inputs. Soft robotic gloves are lightweight, adaptable, and offer rehabilitation potential, helping restore motor function in conditions like stroke or spinal cord injury. They are increasingly used in clinical and home-based therapy settings. | Diagnostic test | SRG |
| EMSElectrical muscle stimulation 30-minute sessions, 5 times per week upto 8 weeks. Electrical Muscle Stimulation (EMS) is a technique that uses electrical impulses to contract muscles, often used for rehabilitation, strength training, or pain management. Electrodes placed on the skin deliver controlled currents to target specific muscle groups, mimicking natural nerve signals. EMS is commonly used in physiotherapy to prevent muscle atrophy, improve circulation, and enhance recovery after injury. It is also utilized in fitness and sports for performance enhancement. Safe and non-invasive, EMS can be adjusted for therapeutic or functional goals. | Diagnostic test | EMS |
Primary outcome
The Fugl-Meyer Upper Extremity Assessment (FMA-UE)
Time frame: 12 Months
The Fugl-Meyer Upper Extremity Assessment (FMA-UE) is a standardized tool used to evaluate motor function, sensation, coordination, and joint motion in individuals with upper limb impairments, often post-stroke. It is based on a hierarchical framework of motor recovery, covering movements from basic reflexes to voluntary motor control. The assessment includes various sections focusing on shoulder, elbow, forearm, wrist, hand, and coordination. Each item measures specific movement tasks, allowing therapists to track progress over time. The FMA-UE is widely used in clinical settings for its reliability and validity in evaluating upper extremity function. Scoring The FMA-UE has 33 items, each scored on a 3-point scale: 0 = Cannot perform 1. = Partially performs 2. = Fully performs The total score ranges from 0 to 66 points (higher scores indicate better motor function).
The Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH)
Time frame: 12 months
The Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) is a shortened version of the DASH outcome measure used to assess physical function and symptoms in individuals with upper extremity conditions. It consists of 11 questions evaluating difficulty in performing daily activities, severity of symptoms (pain, tingling, weakness), and social and emotional impacts. The QuickDASH is designed for fast administration and is applicable across various musculoskeletal disorders. It provides insight into functional limitations, helping guide treatment planning. Scoring Each item is rated on a 1-5 Likert scale (1 = no difficulty, 5 = extreme difficulty). Scores are averaged, transformed into a scale of 0 to 100 (0 = no disability, 100 = most severe disability). An optional Work and Sports/Performing Arts module adds context-specific insights.
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 Dec 2024.
- 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 SRG and EMS in people with Stroke, run by Superior 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. 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?
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?
The Fugl-Meyer Upper Extremity Assessment (FMA-UE) (time frame: 12 Months). The study lists 2 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 18 Dec 2024.