NCT07160114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 30, 2025

Last Update Submit

August 30, 2025

Conditions

Keywords

Stroke rehabilitationElectrical stimulation gloveTask-oriented trainingUpper extremity functionHand dexterity

Outcome Measures

Primary Outcomes (1)

  • Change in Upper Extremity Motor Function (Fugl-Meyer Assessment - Upper Extremity, FMA-U)

    The Fugl-Meyer Assessment - Upper Extremity is a stroke-specific, performance-based scale that evaluates motor function, balance, sensation, and joint functioning. In this study, it is used to assess changes in upper limb motor recovery after intervention.

    Baseline and 8 weeks post-intervention

Secondary Outcomes (2)

  • Change in Functional Performance (Wolf Functional Test, WFT)

    Baseline and 8 weeks post-intervention

  • Change in Hand Dexterity (Functional Dexterity Test, FDT)

    Baseline and 8 weeks post-intervention

Study Arms (2)

Task-Oriented Training with Electrical Stimulation Glove

EXPERIMENTAL

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.

Device: Electrical Stimulation Glove with Task-Oriented Training

Task-Oriented Training Only

ACTIVE COMPARATOR

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.

Behavioral: Task-Oriented Training Only

Interventions

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 with Electrical Stimulation Glove

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.

Task-Oriented Training Only

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, 54590, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 26180053BACKGROUND
  • 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.

    PMID: 24015934BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

August 30, 2025

First Posted

September 8, 2025

Study Start

April 15, 2025

Primary Completion

August 19, 2025

Study Completion

August 28, 2025

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations