EMG Biofeedback and NMES of Deltoid in Patients With rTSA

NCT06873022 | Recruiting

• 1 other identifier: 202403141DINE
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Reverse Shoulder Replacement

Keywords

reverse total shoulder arthroplasty; neuromuscular electrical stimulation; surface electromyography; biofeedback; scapulohumeral rhythm

Outcome Measures

Primary Outcomes (2)

• Muscle activation

  Muscle activation The muscle activation of upper trapezius, lower trapezius, serrates anterior, and deltoid were collected during arm elevation task by sEMG at baseline, post- sEMG biofeedback, and post- NMES. Muscle activation was analyzed based on 0°-30°, 30°-60°, and 60°-90° during arm elevation and lowering. The sEMG data was calculated using the root mean square (RMS) based on average of middle three from five trials. The MVIC of UT, LT, SA, and D were used to normalize the sEMG data.

  before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)

• Scapular kinematics

  Scapular kinematics The scapular kinematics during arm elevation task was captured using an electromagnetic motion analysis system. The three scapula orientations were described using the Euler angle sequence with an X-axis for scapular posterior/anterior tilt, Y-axis for scapular upward/downward rotation, and Z-axis for scapular internal/external rotation. The average of middle three from five trials on scapular kinematics were analyzed at 30°, 60°, and 90° arm elevation and lowering.

  before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)

Secondary Outcomes (2)

• Muscle balance ratios

  before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)

• Scapulohumeral rhythm

  before intervention (baseline) and through intervention completion, an average 15 minutes in each intervention (sEMG biofeedback or NMES)

Study Arms (2)

biofeedback

EXPERIMENTAL

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).

Device: biofeedback

neuromuscular electrical stimulation

EXPERIMENTAL

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.

Device: neuromuscular electrical stimulation

Interventions

neuromuscular electrical stimulation 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.

neuromuscular electrical stimulation

biofeedback 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).

biofeedback

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

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

Taipei, Zhongzheng Dist., 100, Taiwan

RECRUITING

MeSH Terms

Interventions

Biofeedback, Psychology

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Jiu-Jenq Lin, Ph.D

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

  STUDY CHAIR

Central Study Contacts

YANG-TING CHIEN

CONTACT

+886980602820; yangting890218@gmail.com

Jiu-Jenq Lin, Ph.D

CONTACT

+8862-3366-8126; jiujlin@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 12, 2025
• Study Start: March 15, 2025
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: March 12, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)