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

NCT ID: NCT07160114

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-08-28

Brief 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

Stroke; Chronic Stroke Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Task-Oriented Training with Electrical Stimulation Glove

Participants receive task-oriented training combined with an electrical stimulation glove. Sessions include warm-up exercises, functional activities (such as pegboard tasks, grasp-and-release of objects, writing, and simulated daily activities), and cool-down stretches. The glove delivers low-intensity electrical impulses to the wrist and finger muscles during training to facilitate neuromuscular activation and enhance motor recovery. Sessions last approximately 60 minutes, three times per week for 8 weeks.

Group Type: EXPERIMENTAL

Electrical Stimulation Glove with Task-Oriented Training

Intervention Type: DEVICE

Participants 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.

Task-Oriented Training Only

Participants receive task-oriented training without the electrical stimulation glove. Sessions include warm-up exercises, functional activities (such as pegboard placement, grasp-and-release of objects, writing or drawing, and simulated daily activities), and cool-down stretches. This protocol provides standard rehabilitation focusing on functional use of the affected hand. Sessions last approximately 60 minutes, three times per week for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Task-Oriented Training Only

Intervention Type: BEHAVIORAL

Participants 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.

Interventions

Electrical Stimulation Glove with Task-Oriented Training

Participants 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.

Intervention Type: DEVICE

Task-Oriented Training Only

Participants 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients after the six months of first stroke event (chronic stroke patient)
• Mini mental scale grade (24/above)
• Medically and neurologically stable condition
• No visual or auditory defects (Anderson & White, 2023)

Exclusion Criteria

• Pre-existing arm impairment such as rheumatoid arthritis
• Cardiac pacemaker
• Patients with other neurological impairments
• Recurrent or progressive stroke
• Unconscious patients due to any other cause
• History of seizure within 2 years (Anderson & White, 2023)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Ayesha waris

Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Lahore Teaching Hospital

Lahore, , Pakistan

Countries

Pakistan

References

Ackerley SJ, Byblow WD, Barber PA, MacDonald H, McIntyre-Robinson A, Stinear CM. Primed Physical Therapy Enhances Recovery of Upper Limb Function in Chronic Stroke Patients. Neurorehabil Neural Repair. 2016 May;30(4):339-48. doi: 10.1177/1545968315595285. Epub 2015 Jul 15.

Reference Type: BACKGROUND

PMID: 26180053 (View on PubMed)

Abo M, Kakuda W, Momosaki R, Harashima H, Kojima M, Watanabe S, Sato T, Yokoi A, Umemori T, Sasanuma J. Randomized, multicenter, comparative study of NEURO versus CIMT in poststroke patients with upper limb hemiparesis: the NEURO-VERIFY Study. Int J Stroke. 2014 Jul;9(5):607-12. doi: 10.1111/ijs.12100. Epub 2013 Sep 9.

Reference Type: BACKGROUND

PMID: 24015934 (View on PubMed)

Other Identifiers

UOL/IREB/25/09/0031

Identifier Type: -

Identifier Source: org_study_id