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

NCT06739733 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/748
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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 1. = Partially performs 2. = Fully performs The total score ranges from 0 to 66 points (higher scores indicate better motor function).

  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.

  12 months

Study Arms (2)

SRG

EXPERIMENTAL

Diagnostic Test: SRG

EMS

ACTIVE COMPARATOR

Diagnostic Test: EMS

Interventions

SRG 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.

SRG

EMS 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.

EMS

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Ahmad block garden town canal road

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)