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Efficacy of Sensory Electrical Stimulation Versus Alternating Electromyogram (EMG) On Functional Recovery Of Hand in Chronic Stroke Survivors :Randomized Controlled Trial

S

Suez University

Status

Completed

Conditions

Chronic Stroke Survivors
Chronic Stroke Survivors With Plegic Hand

Treatments

Device: Peripheral sensory electrical stimulation via Elettronica Pagani Roland series model: ET 20 S/N: 1907 (Made in Italy)
Device: Alternating electromyogram (EMG) neuromuscular electrical stimulation via MyoTrac Infiniti device (T9800, Thought Technology Ltd. Montreal, Quebec, Canada)

Study type

Interventional

Funder types

Other

Identifiers

NCT06836596
P.T.REC/012/004916

Details and patient eligibility

About

This study aims to find out which treatment works better for improving hand function in stroke patients: sensory electrical stimulation or alternating electromyogram (EMG) stimulation. Both methods use electrical stimulation to help patients regain hand movement, but they work in slightly different ways. The goal is to see if one method is more effective than the other in helping stroke survivors recover their hand abilities.

Enrollment

60 patients

Sex

All

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chronic stroke patients were between 45 and 65 years old, with a duration of illness ranging from 6 to 18 months post-stroke. They exhibited upper extremity spasticity no greater than 1+ on the Modified Ashworth Scale. Patients were cooperative, as indicated by a Mini-Mental State Examination (MMSE) score of ≥ 24, and were capable of grasping and releasing at least one block in the Box and Block Test.

Exclusion criteria

  • Hand function impairment caused by factors other than stroke, unstable health conditions such as cardiac dysfunction, end-stage renal failure, or uncontrolled diabetes, long-term use of medications that may affect motor or sensory excitability, contractures or restrictions in wrist joint range of motion, pre-existing musculoskeletal diseases significantly impacting physical function, and a history of Botulinum Toxin injection in the hand muscles.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Group A (Sensory Electrical Stimulation Group)
Experimental group
Description:
This group receives the active treatment of peripheral sensory electrical stimulation along with the hand function training program, making it the experimental group being tested for its effects on improving hand function in stroke patients.
Treatment:
Device: Peripheral sensory electrical stimulation via Elettronica Pagani Roland series model: ET 20 S/N: 1907 (Made in Italy)
Group B (Alternating EMG Stimulation Group)
Active Comparator group
Description:
This is because this group is receiving a different active treatment (alternating EMG stimulation) along with hand function training, and it is being compared to the other active treatment (sensory electrical stimulation) in Group A. Both groups are experimental, but Group B serves as a comparison to Group A in the study.
Treatment:
Device: Alternating electromyogram (EMG) neuromuscular electrical stimulation via MyoTrac Infiniti device (T9800, Thought Technology Ltd. Montreal, Quebec, Canada)
Group C (Control Group)
No Intervention group
Description:
Group C only receives the designed hand function training program and does not receive any form of electrical stimulation, the electrodes are used, but no active stimulation is delivered. It serves as the control group for comparison against the experimental treatments in Groups A and B.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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