Comprehensive Protocol for Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients

NACompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

August 3, 2023

Primary Completion Date

November 12, 2023

Study Completion Date

December 3, 2023

Conditions
Post-stroke Upper Limb Spasticity
Interventions
PROCEDURE

Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)

"1. Low-frequency transcranial electrical stimulation (2/100 Hz) applied through 0.3-mm-diameter and 40-mm-long needles placed subcutaneously on the scalp at the projection of Penfield's motor homunculus and sensory and frontal supplementary motor associative areas.~2. Paraspinous block at the levels of the C5, C6 and C7 vertebrae concordant with spasticity laterality.~3. Dry needling of spastic upper limb muscles, as identified through a thorough physical examination, using 0.3-mm-diameter and 40-mm-long needles.~4. Muscular functional electrical stimulation (FES) in the antagonists of the upper limb muscles with spasticity with the following parameters: 20-Hz frequency, 300-µs pulse width, zero-second ramp time, 5-second stimulation time, and 5-second resting time."

PROCEDURE

SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)

For simulation of transcranial electrical stimulation and FES, electrodes were placed on the scalp and in the upper extremity muscles and were connected to a device similar to the real electric current generator. This device did not transmit any electric current but had blinking lights and produced sound to provide the subjects visual and auditory feedback. To simulate dry needling and paraspinous block, retractile needles were used.

Trial Locations (1)

05403010

University of São Paulo General Hospital, São Paulo

All Listed Sponsors
lead

University of Sao Paulo General Hospital

OTHER

NCT05940805 - Comprehensive Protocol for Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients | Biotech Hunter | Biotech Hunter