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Effectiveness of Soft Robotic Glove Versus EMS on Hand Function and Quality of Life in Stroke Survivors (RCT)

S

Superior University

Status

Active, not recruiting

Conditions

Stroke

Treatments

Diagnostic Test: EMS
Diagnostic Test: SRG

Study type

Interventional

Funder types

Other

Identifiers

NCT06739733
MSRSW/Batch-Fall22/748

Details and patient eligibility

About

This study will evaluate the effectiveness of soft robotic gloves versus electrical muscle stimulation (EMS) in improving hand function and quality of life in stroke survivors. Stroke often leads to impaired hand mobility, impacting daily activities and reducing overall quality of life. Soft robotic gloves, designed to assist with hand movement, will provide mechanical support and encourage voluntary muscle activity. EMS, on the other hand, will stimulate muscle contraction through electrical impulses, potentially enhancing muscle strength and coordination.

Full description

Participants will be divided into two groups: one will receive treatment using soft robotic gloves, and the other with EMS. Outcomes will be assessed using standardized hand function tests and quality-of-life questionnaires over a specified period. Results are expected to indicate that both interventions will improve hand function and quality of life, with the robotic gloves showing a marginally greater improvement in dexterity and grip strength, while EMS will yield benefits in muscle reactivation and endurance. Stroke survivors in the robotic glove group are anticipated to report greater ease in performing daily tasks, while the EMS group will note an increase in muscle engagement.

Enrollment

36 patients

Sex

All

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Had ischemic or hemorrhagic stroke ≤6 months.
  • Mini-mental status exam scores > 24(7).
  • GCS score 11 to 15(2)
  • FMA-UE score < 21(3)

Exclusion criteria

  • Participants with severe vision or hearing impairment.
  • Neurological disorders including epilepsy, Alzheimer's disease, vertigo, Parkinson disease, and , muscular disorders which limit functional activity (OA, RA, etc).
  • Peripheral vestibular disorder.
  • Medications that affect balance, severe cardiovascular conditions, recent lower limb injury or surgery.
  • Contraindications for EMS: Patients with certain medical conditions, such as pacemakers, implantable cardioverter-defibrillators, or metal fragments in their body, that contraindicated the use of EMS were excluded.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

SRG
Experimental group
Treatment:
Diagnostic Test: SRG
EMS
Active Comparator group
Treatment:
Diagnostic Test: EMS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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