Effects of Neuromuscular Electrical Stimulation on Flexor Spasticity and Function in Stroke Patients

Completed

• Conditions: Stroke; Spastic Hemiplegia

• Registration Number: NCT06725069
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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.

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-10-31
• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-07
• Study First Posted: 2024-12-10
• Study Completion: 2025-01-14
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Modified Ashworth Scale (MAS)	Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).	The Modified Ashworth Scale (MAS) is a clinical tool used to assess spasticity, which is characterized by increased muscle tone and resistance to passive movement. It is commonly applied in individuals with neurological conditions such as stroke, multiple sclerosis, or cerebral palsy. The scale involves passively moving a limb through its range of motion and evaluating the resistance felt. The scoring ranges from 0 to 4, where 0 indicates no increase in muscle tone, 1 represents a slight increase with a catch or minimal resistance at the end of the range, and 1+ reflects a catch followed by minimal resistance through less than half of the movement. A score of 2 denotes a more marked increase in tone through most of the range, but the limb remains movable. 3 indicates considerable resistance, making movement difficult, and 4 signifies a rigid limb with severe spasticity. This scale is widely used in rehabilitation to monitor spasticity and guide treatment interventions.
Brunnstrom	Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).	The Brunnstrom Stages of Recovery describe the six stages of motor recovery following a stroke or brain injury. In Stage 1, there is flaccidity, with no voluntary movement or reflex activity in the affected limb. Stage 2 marks the beginning of spasticity, with the emergence of basic limb synergies and minimal voluntary movement. In Stage 3, spasticity reaches its peak, and voluntary control is limited to synergy patterns. Stage 4 involves a decrease in spasticity, with the appearance of some voluntary movements outside of synergy patterns. By Stage 5, spasticity continues to decline, and more complex and isolated movements become possible. Finally, in Stage 6, normal movement patterns are largely restored, with minimal or no spasticity and full control of isolated joint movements.

Trial Locations

Locations (1)

SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi; 🇹🇷 Ankara, Turkey