Clinical Trials Directory

Trials / Completed

CompletedNCT07160114

Task-oriented Training With Electrical Stimulation Glove on Hand Function and Dexterity in Chronic Stroke Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
University of Lahore · Academic / Other
Sex
All
Age
40 Years – 60 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
DEVICEElectrical 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.
BEHAVIORALTask-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.

Timeline

Start date
2025-04-15
Primary completion
2025-08-19
Completion
2025-08-28
First posted
2025-09-08
Last updated
2025-09-08

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT07160114. Inclusion in this directory is not an endorsement.