Clinical trial NCT06725069: Effects of Neuromuscular Electrical Stimulation on Flexor Spasticity and Function in Stroke Patients
Official title: Effects of Neuromuscular Electrical Stimulation Applied to Agonist or Antagonist Muscles of the Upper Extremity on Flexor Spasticity and Function in Patients With Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Spastic Hemiplegia
Keywords: stroke
neuromuscular electrical stimulation
rehabilitation
hemiplegia
spasticity
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed with ischemic or hemorhagic stroke after imaging with CT/MRI

Brief summary: In this study, the investigators aimed to determine the effects of botulinum neurotoxin type A injections for wrist and finger flexor spasticity and neuromuscular electrical stimulation therapy applied to wrist and finger flexors or extensors on upper extremity flexor spasticity and function in stroke patients.

Detailed description: Neuromuscular electrical stimulation therapy applied to wrist and finger flexors (agonist application) or wrist and finger extensors (antagonist application) after botulinum neurotoxin type A injections in stroke patients with wrist and finger flexor spasticity in upper extremity flexor spasticity, To determine the effects on motor recovery, upper extremity and hand functions, hand grip strength, range of motion, functional independence, quality of life, hand skills and sonographically evaluated muscle thickness and to compare these different applications.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with ischemic or hemorhagic stroke after imaging with CT/MRI
2. First time stroke survivor
3. between 45-75 years old
4. Stroke duration \> 3 months
5. Neurologically stable
6. Affected wrist and finger flexor muscle spasticity with MAS≥2
7. Patients whose cognitive status is at a level to understand the study instructions MMT\> 23)

Exclusion Criteria:

1. Presence of another neurological disorder other than stroke causing motor impairment/spasticity
2. Fixed contracture in the hand-wrist
3. Use of medical treatment for spasticity
4. Having received neurolytic therapy, BoNT-A injection or NMES treatment in the last 3 months
5. Skin problem (disease, allergy, infection, etc.) on the contact surface of the NMES
6. Complex regional pain syndrome (CRPS), sequelae of previous trauma or surgery (muscle tendon adhesion, peripheral nerve damage) in the affected extremity
7. Having a pacemaker
8. Epilepsy
9. Malignancy

Primary outcomes:
measure: The Modified Ashworth Scale (MAS)
timeFrame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).
measure: Brunnstrom
timeFrame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Eda Gürçay, Prof.
role: STUDY_DIRECTOR
References: