Electrotherapeutic Interventions for Glenohumeral Subluxation After Stroke

Official title

Comparison of the Clinical and Sonographic Outcomes of NMES and EMG Biofeedback Therapies in Stroke Patients With Glenohumeral Subluxation: Randomized Clinical Trial

Overview

The aim of this single-blind randomized controlled trial is to compare the effects of two therapies-neuromuscular electrical stimulation (NMES) and electromyographic (EMG) biofeedback-in stroke patients with shoulder (glenohumeral) subluxation. The study will evaluate changes in shoulder structure and function by measuring the acromion-greater tuberosity distance, supraspinatus and posterior deltoid muscle thickness, shoulder range of motion, and Brunnstrom stage of the upper extremity and hand. Clinical outcomes such as shoulder pain, stroke-specific quality of life, and the Shoulder Pain and Disability Index (SPADI) will also be assessed. This trial is designed to provide evidence on which therapy may be more effective for improving shoulder stability, reducing pain, and enhancing quality of life in stroke survivors with shoulder subluxation.

Detailed description

Shoulder (glenohumeral) subluxation is a common complication after stroke and is associated with pain, impaired upper limb function, and decreased quality of life. Despite the availability of different rehabilitation methods, there is still no clear consensus on the most effective approach for managing post-stroke shoulder subluxation.

The aim of this single-blind, randomized controlled trial is to compare the effects of two electrotherapeutic interventions-neuromuscular electrical stimulation (NMES) and electromyographic (EMG) biofeedback-on both structural and functional outcomes in stroke patients with glenohumeral subluxation.

Participants will be randomly assigned to either the NMES group or the EMG biofeedback group, in addition to receiving standard rehabilitation. The study will evaluate structural outcomes using ultrasonographic measures, including the acromion-greater tuberosity distance and supraspinatus and posterior deltoid muscle thickness. Functional outcomes will include shoulder range of motion and Brunnstrom stages of the upper extremity and hand. Clinical outcomes will be assessed using pain scores, the Stroke-Specific Quality of Life Scale, and the Shoulder Pain and Disability Index (SPADI).

This trial is expected to provide evidence regarding the comparative effectiveness of NMES and EMG biofeedback in improving shoulder stability, reducing pain, and enhancing functional recovery and quality of life in stroke survivors with shoulder subluxation.

Interventions

• Device Neuromuscular electrical stimulation
  Neuromuscular electrical stimulation (NMES) will be administered to the supraspinatus and posterior deltoid muscles for 20 minutes daily, five days per week, over a period of three weeks, totaling 15 treatment sessions. All groups will undergo a conventional physiotherapy program consisting of 45-minute sessions, five days per week, for three weeks, totaling 15 sessions. The program will comprise range of motion exercises, stretching, progressive resistive exercises, and activities of daily livi
• Device Electromyographic (EMG) biofeedback
  Electromyographic (EMG) biofeedback therapy will be applied to the supraspinatus and posterior deltoid muscles for 20 minutes daily, five days per week, over a period of three weeks, totaling 15 treatment sessions. All groups will undergo a conventional physiotherapy program consisting of 45-minute sessions, five days per week, for three weeks, totaling 15 sessions. The program will comprise range of motion exercises, stretching, progressive resistive exercises, and activities of daily living-or
• Other Conventional physiotherapy
  This group will participate exclusively in a conventional physiotherapy program for 45 minutes daily, five days per week, over a period of three weeks, totaling 15 sessions. The conventional program will include range of motion exercises, stretching, progressive resistive exercises, and exercises targeting activities of daily living.

Primary outcome measures

• Acromion-Greater Tuberosity Distance (AGT Distance) - Musculoskeletal Ultrasound Measurement [Time frame: Baseline and Week 3]
• Supraspinatus Muscle Thickness Measured by Musculoskeletal Ultrasound [Time frame: Baseline (Week 0) and Week 3]
• Posterior Deltoid Muscle Thickness Measured by Musculoskeletal Ultrasound [Time frame: Baseline (Week 0) and Week 3]
• Motor Function [Time frame: Baseline and Week 3]

Secondary outcome measures (4)

• Visual Analog Scale [Time frame: Baseline and Week 3]
• Passive Shoulder Range of Motion (ROM) [Time frame: Baseline and Week 3]
• Shoulder Pain and Disability Index (SPADI) [Time frame: Baseline and Week 3]
• Stroke-Specific Quality of Life Scale (SS-QOL) [Time frame: Baseline and Week 3]

Eligibility criteria

Inclusion criteria

• ≥18 years of age,
• Disease duration >3 months,
• Glenohumeral subluxation (GHS) confirmed by ultrasonography (USG),
• Upper extremity and hand Brunnstrom motor stages between 2 and 5

Exclusion criteria

• Mini-Mental State Examination (MMSE) score <24,
• Visual/hearing impairments, or neglect,
• Steroid injection for shoulder pain within the last 3 months,
• Unstable systemic disease,
• Spasticity with Modified Ashworth Scale (MAS) score 3-4,
• Presence of metal implants or pacemaker

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Gaziler Physical Therapy and Rehabilitation Training and Research Hospital — Ankara

Publications

• Turkkan C, Ozturk GT, Ugurlu FG, Ersoz M. Ultrasonographic assessment of neuromuscular electrical stimulation efficacy on glenohumeral subluxation in patients with hemiplegia: a randomized-controlled study. Turk J Phys Med Rehabil. 2017 May 17;63(4):287-292. doi: 10.5606/tftrd.2017.953. eCollection 2017 Dec. PMID 31453469
• Whitehair VC, Chae J, Hisel T, Wilson RD. The effect of electrical stimulation on impairment of the painful post-stroke shoulder. Top Stroke Rehabil. 2019 Oct;26(7):544-547. doi: 10.1080/10749357.2019.1633796. Epub 2019 Jul 12. PMID 31298627
• Chuang LL, Chen YL, Chen CC, Li YC, Wong AM, Hsu AL, Chang YJ. Effect of EMG-triggered neuromuscular electrical stimulation with bilateral arm training on hemiplegic shoulder pain and arm function after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2017 Nov 28;14(1):122. doi: 10.1186/s12984-017-0332-0. PMID 29183339

Identifiers

NCT: NCT07423455 · AEŞH-EK-2025-115

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗