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NCT Number: NCT07282938

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebro-vascular Accident Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Society for the Rehabilitation of the Disabled (PSRD), Lahore, Punjab Province, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soft Robotic Hand combined with Neuromuscular Electrical Stimulation along with Task Oriented Training

Other

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: Soft Robotic Hand, robotic assisted therapy, electrical stimulation, soft robotic hand and electrical stimulation, task oriented training

Neuromuscular Electrical Stimulation along with Task Oriented Training

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amna Naveed, DPT

CONTACT

[email protected]

+923178731632

Aruba Saeed, PhD

CONTACT

[email protected]

+923344399403

Sponsors and collaborators

Lead sponsor

Lahore University of Biological and Applied Sciences

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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