RecruitingNot ApplicableNCT07282938

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

Sponsor

Lahore University of Biological and Applied Sciences

Enrollment

64 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke Cerebro-vascular Accident

Summary

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.

Eligibility

Min Age: 45 YearsMax Age: 65 Years

Inclusion Criteria6

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 Criteria3

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

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Interventions

OTHERSoft 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.

OTHERNeuromuscular 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.