Soft robotic hand plus electrical stimulation to improve hand function after stroke

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

This will try using a soft robotic hand together with electrical stimulation to help people 3–6 months after a first stroke regain hand strength and dexterity.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 45 Years to 65 Years
• Sex: All
• Sponsor: Lahore University of Biological and Applied Sciences (other)
• Locations: 2 sites (Lahore, Punjab Province and 1 other locations)
• Trial ID: NCT07282938 on ClinicalTrials.gov

What this trial studies

This interventional program enrolls people 3–6 months after a first stroke with preserved cognition and mild spasticity and compares combined soft robotic hand assistance plus neuromuscular electrical stimulation with neuromuscular electrical stimulation plus task-oriented training alone. Participants receive repeated supervised therapy sessions at rehabilitation centers in Lahore and undergo standardized assessments before and after the intervention period. Outcomes include grip strength, dexterity, functional use in activities of daily living, and safety/tolerability measures. The protocol tests whether simultaneous mechanical assistance and electrical stimulation produces faster or greater hand-function recovery than electrical stimulation plus task training by itself.

Who should consider this trial

Good fit: Ideal participants are adults with a first-ever stroke 3–6 months earlier, normal cognition (MOCA ≥24), mild spasticity (Modified Ashworth Scale <2), ability for passive finger extension, NIHSS score 10–16, and no finger sensory disturbance or other conditions limiting task performance.

Not a fit: People with severe spasticity, significant finger sensory loss, other neurologic or orthopedic disorders, impaired cognition, or those outside the 3–6 month post-stroke window are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combined approach could speed recovery of hand strength and dexterity and improve independence in daily activities.

How similar studies have performed: Prior studies have shown benefits from soft robotic gloves and from electrical stimulation individually, but the simultaneous combination of these two therapies is novel and not yet well established.

Eligibility criteria

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

Where this trial is running

Lahore, Punjab Province and 1 other locations

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

Study contacts

• Principal investigator: Aruba Saeed, PhD — Lahore University of Biological and Applied sciences, UBAS
• Study coordinator: Amna Naveed, DPT

Conditions: Stroke, Cerebro-vascular Accident, hand impairments, soft robotic hand, electrical stimulation, robotic therapy, Cerebrovascular accident