EMG Biofeedback and NMES of Deltoid in Patients With rTSA

NCT ID: NCT06873022

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-05-20

Brief Summary

The effect of NMES and surface electromyography (sEMG) biofeedback on the deltoid and associated scapular muscles in scapular kinematics and muscle activation in individual post rTSA

Detailed Description

Reverse total shoulder arthroplasty (rTSA) has been the optimal treatment for massive irreparable rotator cuff tears and cuff tear arthropathy. Since scapular kinematics alteration was associated with shoulder disorders, scapular kinematics had been characterized in individuals post rTSA with more upward rotation, external rotation, and posterior tilt of the scapula. In addition, the average scapulohumeral rhythm ranged from 1.1 to 1.6, indicating lower glenohumeral joint movements and higher scapulothoracic movements. It supposed that more scapula upward rotation without adequate humeral elevation can result in the scapula notching. Therefore, strategy to decrease scapular movement or increase humeral movements during arm movements may prevent scapula notching. To compensate for rotator cuff deficiency, the deltoid muscle plays a crucial role post rTSA. Enhancing deltoid function can be accomplished through the use of biofeedback or neuromuscular electrical stimulation (NMES). However, the effect of NMES and surface electromyography (sEMG) biofeedback on the deltoid and associated scapular muscles in scapular kinematics, muscle activation, and muscle balance ratio in individual post rTSA remained unclear. Therefore, the objectives in this study would to (1) determine the immediate effects of NMES with EMG biofeedback to deltoid (D) on the muscle activation of upper trapezius (UT), lower Trapezius (LT) and serratus Anterior (SA) as well as the scapular kinematics (upward/downward rotation, external/internal rotation, anterior/posterior tilting) (2) evaluate the immediate effects of NMES with EMG biofeedback on the muscle balance ratios (D/UT, D/LT, D/SA) and the scapulohumeral rhythm (SHR) during arm elevation in the scapular plane at different range of motion.

Conditions

Reverse Shoulder Replacement

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

biofeedback

sEMG biofeedback: Subjects were instructed to monitor the sEMG signals of the D/UT balances ratio on the screen and maintain the D/UT balances ratio above the threshold during arm elevation and lowering. The threshold was set at 1 standard deviation of the ratio average at baseline (before intervention).

Group Type: EXPERIMENTAL

biofeedback

Intervention Type: DEVICE

sEMG biofeedback: Subjects were instructed to monitor the sEMG signals of the D/UT balances ratio on the screen and maintain the D/UT balances ratio above the threshold during arm elevation and lowering. The threshold was set at 1 standard deviation of the ratio average at baseline (before intervention).

neuromuscular electrical stimulation

NMES: Two electrode pads were placed on the anterior, middle, and posterior deltoid boundary lines and at a distance of 1cm distal to the lateral margin of the acromion. The operator palpated the deltoid muscle contraction and asked the subjects to perform arm elevation task with NMES. (frequency of 35 Hz and a duration of 250 microseconds.) A verbal cue was given during both th A verbal cue was given during both the sEMG biofeedback and NMES interventions: "Lengthen your arm as if you want to touch the ground, the scapula keeps in the neutral position, and then elevate your arm." Each intervention consisted of 3 sets of 10 repetitions per set, with a 1-minute rest between sets.

Group Type: EXPERIMENTAL

neuromuscular electrical stimulation

Intervention Type: DEVICE

NMES: Two electrode pads were placed on the anterior, middle, and posterior deltoid boundary lines and at a distance of 1cm distal to the lateral margin of the acromion. The operator palpated the deltoid muscle contraction and asked the subjects to perform arm elevation task with NMES. (frequency of 35 Hz and a duration of 250 microseconds.) A verbal cue was given during both th

A verbal cue was given during both the sEMG biofeedback and NMES interventions: "Lengthen your arm as if you want to touch the ground, the scapula keeps in the neutral position, and then elevate your arm." Each intervention consisted of 3 sets of 10 repetitions per set, with a 1-minute rest between sets.

Interventions

neuromuscular electrical stimulation

NMES: Two electrode pads were placed on the anterior, middle, and posterior deltoid boundary lines and at a distance of 1cm distal to the lateral margin of the acromion. The operator palpated the deltoid muscle contraction and asked the subjects to perform arm elevation task with NMES. (frequency of 35 Hz and a duration of 250 microseconds.) A verbal cue was given during both th

A verbal cue was given during both the sEMG biofeedback and NMES interventions: "Lengthen your arm as if you want to touch the ground, the scapula keeps in the neutral position, and then elevate your arm." Each intervention consisted of 3 sets of 10 repetitions per set, with a 1-minute rest between sets.

Intervention Type: DEVICE

biofeedback

sEMG biofeedback: Subjects were instructed to monitor the sEMG signals of the D/UT balances ratio on the screen and maintain the D/UT balances ratio above the threshold during arm elevation and lowering. The threshold was set at 1 standard deviation of the ratio average at baseline (before intervention).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• (1) age between 20 to 85 years old
• (2) undergoing primary reverse shoulder arthroplasty
• (3) shoulder abduction in scapular plane above 90 degrees
• (4) above 3 months following rTSA

Exclusion Criteria

• (1) a history of other shoulder surgery on the rTSA shoulder
• (2) a revision rTSA
• (3) a surgery shoulder muscle tendon transfer
• (4) neuromuscular diseases
• (5) cognitive disorders
• (6) contraindications for NMES

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiu-Jenq Lin, Ph.D

Role: STUDY_CHAIR

School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan

Locations

National Taiwan University of school and graduate of physical therapy of Performance Analysis Laboratory

Taipei, Zhongzheng Dist., Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

YANG-TING CHIEN

Role: CONTACT

yangting890218@gmail.com

+886980602820

Jiu-Jenq Lin, Ph.D

Role: CONTACT

jiujlin@ntu.edu.tw

+8862-3366-8126

Facility Contacts

YANG-TING CHIEN

Role: primary

yangting890218@gmail.com

+886980602820

Other Identifiers

202403141DINE

Identifier Type: -

Identifier Source: org_study_id