Study of the Effectiveness of "Fesia Grasp": Functional Electrical Stimulation Device for Upper Limb Rehabilitation After Stroke (PI52021Rehab)

M

Maimónides Biomedical Research Institute of Córdoba

Status

Enrolling

Conditions

Upper Extremity Paresis
Stroke

Treatments

Other: Standard therapy
Device: Functional electrical stimulation through medical device

Study type

Interventional

Funder types

Other

Identifiers

NCT04992910
PI52021Rehab

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of Fesia Grasp, a Functional Electrical Stimulation device for the rehabilitation of upper limb in post-stroke patients. Fesia Grasp rehabilitation will be compared with usual care rehabilitation of upper limb. Experimental group: patients will receive Fesia Grasp therapy (intensive, repetitive and functional exercises assisted by functional electrical stimulation) Control group - patients will receive standard care.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 years old or older subjects with hemiparesis in the upper limb after stroke, which have been referred to the Rehabilitation Unit of the Reina University Hospital.
  • Unilateral paresis
  • Cognitive ability to assimilate and actively participate in the protocol of evaluation and treatment

Exclusion criteria

  • Very severe proximal spasticity: Ashworth > 3.
  • Psychiatric illness (including post-stroke depression).
  • Cognitive impairment.
  • Inability to provide informed consent.
  • Other severe medical problems.
  • Severe hemi-spatial neglect or anosognosia involving the affected arm.
  • Pacemakers
  • Pregnant women.
  • Skin ulcers.
  • Peripheral neuropathies.
  • Edema of the affected forearm and / or hand.
  • Severe pain.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Functional Electrical Stimulation
Experimental group
Treatment:
Device: Functional electrical stimulation through medical device
Standard Therapy
Active Comparator group
Treatment:
Other: Standard therapy

Trial contacts and locations

0

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Central trial contact

Silvia Guillén Climent; Fernando Mayordomo Riera, MD

Data sourced from clinicaltrials.gov

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