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

Not Applicable

Active, not recruiting

• Conditions: Stroke

• Registration Number: NCT06739733
• Lead Sponsor: Superior University

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.

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-10-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Fugl-Meyer Upper Extremity Assessment (FMA-UE)	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)	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.

Trial Locations

Locations (1)

Ahmad block garden town canal road; 🇵🇰 Lahore, Punjab, Pakistan