Effectiveness of Soft Robotic Glove Versus EMS on Hand Function and Quality of Life in Stroke Survivors (RCT)

NCT ID: NCT06739733

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-03-01

Brief 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. 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SRG

Group Type: EXPERIMENTAL

SRG

Intervention Type: DIAGNOSTIC_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.

EMS

Group Type: ACTIVE_COMPARATOR

EMS

Intervention Type: DIAGNOSTIC_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.

Interventions

SRG

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.

Intervention Type: DIAGNOSTIC_TEST

EMS

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmad block garden town canal road

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall22/748

Identifier Type: -

Identifier Source: org_study_id