Combined Effects of Soft Robotic Hand and Electrical Stimulation on Hand Function in Stroke Survivors

January 11, 2026 updated by: Lahore University of Biological and Applied Sciences
Stroke is a clinically delineated syndrome, which is characterised by an acute, focal neurological deficit resulting from vascular injury (infarction or haemorrhage) within the central nervous system. Notably, around 80 percent of stroke survivors experience post-stroke deficits in upper extremity (UE) motor performance, impacting grip strength, dexterity, and functional independence, which greatly hinder the ability of stroke patients to carry out activities of daily living (ADL), and in turn affects their overall quality of life (QOL).One potential solution to these difficulties is the creation of rehabilitation robotic devices that incorporate hand technology and electrical stimulation. Although soft robotic assistive devices and electrical stimulation have each shown positive effects on motor recovery, their combined use has yet to be thoroughly investigated. This study intends to determine if the simultaneous application of these therapies can speed up rehabilitation results in comparison to independent therapies. Stroke Participants will be divided into two groups, Experimental group and Control group. Both the groups will receive intervention for 40 min/day, 03 days/week, for 08 week and measurements will be taken prior to the treatment, after 4 weeks of treatment and 8 weeks post-treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stroke is the second largest cause of death and disability worldwide. On the basis of cause, there are two major kinds of strokes, 80 % of which are ischemic strokes and 20% are of hemorrhagic stroke. While on the basis of duration stroke is divided as transient ischemic stroke (TIA), acute, sub-acute and chronic stroke. Between 1993/1994 and 2005, the mean age of stroke onset decreased by two years, and the proportion of strokes among individuals aged 20 to 54 increased by approximately 50%, from 12.9% to 18.6%, with ischemic stroke being the most common type. Prevalence of stroke in low-income countries is increasing over the last three decades with an annual increase of 14.3%, and globally, the overall prevalence of stroke in the elderly is estimated at 7.4%. Between 17% and 40% of stroke survivors experience spasticity in their upper extremities, significantly impairing their ability to perform daily tasks. Rehabilitation of the upper limbs is particularly crucial during the first six months following a stroke, as recovery of motor functions and daily living activities significantly diminishes after this period. Beyond this six-month window, up to 66% of patients fail to regain functional upper-limb capabilities. Robot assisted therapy (RAT) is a novel approach used in the stroke rehabilitation to deliver the motor and task-oriented training by utilizing robotic devices. There are many researches working on the effect of soft robotic hand and electrical stimulation and their effect compared with the other physical therapy intervention that are constrained induced movement therapy (CIMT) or Mirror therapy or traditional physical therapy program, but the results for the combined effect of the soft robotic hand and electrical stimulation when applied along with functional task training are still under study. Given the limitations of traditional therapies, the integration of soft robotic hand with electrical stimulation may offer a promising approach to early rehabilitation. This integrated approach can enhance functional recovery by facilitating neuroplasticity and motor relearning through synchronised passive and active movements, thereby promoting greater independence in daily activities. This research aims to develop effective rehabilitation strategies that lower long-term healthcare costs and enhance overall motor recovery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54660
        • Recruiting
        • Shadman Medical Center, Stroke Rehabilitation
      • Lahore, Punjab Province, Pakistan, 54660
        • Recruiting
        • Pakistan Society for the Rehabilitation of the Disabled (PSRD)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with their first episode of stroke.
  • Participants with 3-6 months post stroke.
  • Participants with normal cognition on Montreal Cognitive Assessment (MOCA) ≥24.
  • Participants with the ability to extend Metacarpophalangeal (MCP) and Proximal Interphalangeal (PIP) joint to 180 degree passively
  • Modified Ashworth Scale < 2.
  • Participants with the score of 10 to 16 on National Institute of Health Stroke Scale Score (NIHSS Score).

Exclusion Criteria:

  • Presence of other neurological, neuromuscular, orthopedic diseases, or
  • conditions that may interfere with task performance.
  • Participants with sensory disturbances in the fingers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Group-1 (Soft Robotic Hand + Neuromuscular Electrical Stimulation)
The experimental group will follow a rehabilitation program that combines soft robotic hand support along with electrical muscle stimulation (EMS), and perform task oriented training. Syrebo Hand rehabilitation robotic glove will be used which help the patient to flex and extend the fingers as in open or close a fist and for the stimulation of muscles ComfyStim EMS device will be used, By placing EMS electrodes on the important muscle groups used for gripping, moving the wrist, and making small movements, adjusting the intensity to what each person can handle. After the careful set up of both devices patient will perform task training such as grip-release cycles, reaching to grab objects, pinching small items, and mimicking daily activities like lifting a cup or stacking blocks.
Other: Soft Robotic Hand combined with Neuromuscular Electrical Stimulation along with Task Oriented Training
Group-1, will follow a rehabilitation program that combines soft robotic hand support, electrical muscle stimulation (EMS), and task oriented training. After the adjustment of soft robotic hand, EMS electrodes will be placed on specific muscles, with set FITT principal as, A pulse frequency of 20 to 50 Hz and a pulse duration of 400 μs will be set with the intensity as per tolerated by the participant. Participants will perform task oriented activities that will include, Reaching to grasp objects, Picking up and releasing things at different heights using active finger and wrist extension. Opening a jar, or bottle, Turning a key or doorknob, Holding and lifting a tray or flat object, Pushing objects forward (like sliding a book across) with the assistance of soft robotic hand while electrical simulations are being delivered through the EMS for 40 min/day, 03 days/week, for 08 week. Measurements will be taken prior to the treatment, after 4 weeks of treatment and 8 weeks post-treatment.
Other Names:
  • electrical stimulation
  • task oriented training
  • Soft Robotic Hand
  • robotic assisted therapy
  • soft robotic hand and electrical stimulation
Other: Control: Group-2 ( Neuromuscular Electrical Stimulation)
The control group will follow a rehabilitation program that combines support of electrical stimulation, and task oriented training. For the stimulation of muscles ComfyStim EMS device will be used, by placing EMS electrodes on the important muscle groups used for gripping, moving the wrist, and making small movements, adjusting the intensity to what each person can handle. After the careful set up of EMS device patient will perform task training such as grip-release cycles, reaching to grab objects, pinching small items, and mimicking daily activities like lifting a cup or stacking blocks.
Other: Neuromuscular Electrical Stimulation along with Task Oriented Training
The control group will follow a rehabilitation program that combines support of electrical stimulation, and task oriented training. For the stimulation of muscles ComfyStim EMS device will be used. The FITT principal used for EMS will be as, A pulse frequency of 20 to 50 Hz and a pulse duration of 400 μs will be set with the intensity as per tolerated by the participant. Participants will perform task oriented activities that will include, Reaching to grasp objects, Picking up and releasing things at different heights using active finger and wrist extension. Opening a jar or bottle, Turning a key or doorknob, Holding and lifting a tray or flat object, Pushing objects forward (like sliding a book across) while electrical simulations are being delivered through the EMS for 40 min/day, 03 days/week, for 08 week. Measurements will be taken prior to the treatment, after 4 weeks of treatment and 8 weeks post-treatment.
Other Names:
  • Electrical stimulation
  • Neuromuscular electrical stimulation
  • task oriented training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Wolf Motor Function Test
Time Frame: Measurements will be taken before the treatment as baseline, after 4 weeks of treatment, and 8 weeks post-treatment
Motor hand function will be assessed using the Wolf Motor Function Test (WMFT). The WMFT evaluates functional ability and movement speed through 17 tasks, including 15 timed functional tasks and 2 strength-based tasks. Each task is scored on a 6-point scale (0-5), with higher scores indicating better performance; total scores range from 0 to 85.
Measurements will be taken before the treatment as baseline, after 4 weeks of treatment, and 8 weeks post-treatment
Fugl-meyer assessment of upper limb (FMA-UE)
Time Frame: Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
Motor hand function will be assessed using the Fugl-Meyer Assessment of Upper Extremity (FMA-UE). The FMA-UE has demonstrated excellent test-retest and inter- and intra-rater reliability, and evidence for its content validity. The FMA assesses motor recovery in the upper extremity using a 33-item scale scored from 0 to 2 per item, with a maximum score of 66.
Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
Nine-Peg Hole Test
Time Frame: Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
Dexterity of the affected hand will be assessed using the Nine-Hole Peg Test (NHPT), a standardized and widely used tool for measuring fine motor coordination. Participants are instructed to place nine pegs into nine holes on a board and then remove them as quickly as possible, using one hand at a time. The total time taken to complete the task is recorded in seconds. Shorter completion times indicate better manual dexterity.
Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
Dynamometer
Time Frame: Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
Grip strength will be assessed using a hand-held dynamometer, a reliable tool for measuring isometric muscle force. Participants will be instructed to squeeze the device with maximum effort while seated, with the elbow flexed at 90 degrees and the forearm in a neutral position. Each hand will be tested three times, and the highest value will be recorded. This method provides an objective measure of hand strength and is commonly used in stroke rehabilitation to monitor functional recovery and response to intervention.
Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
Modified Ashworth Scale
Time Frame: Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment.
The Modified Ashworth Scale (MAS) will be used to evaluate muscle spasticity in the affected upper limb. This scale grades resistance during passive soft-tissue stretching on a 6-point ordinal scale (0 to 4, with an additional 1+ grade), where higher scores indicate increased muscle tone. MAS is widely used in stroke rehabilitation to monitor changes in spasticity and assess the effectiveness of interventions aimed at promoting motor recovery.
Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lahore University of Biological and Applied Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aruba Saeed, PhD, Lahore University of Biological and Applied sciences, UBAS

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UBAS/ERB/FoRS/25/040 Amna

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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