Electrical Stimulation in Older Adults

Effect of a Neuromuscular Electrostimulation Protocol on the Triceps Surae in Older Adults

Within the problems associated with population aging and its morbidities, the musculoskeletal system is involved in detrimental changes, compromising, in many cases, the functional capacity of the patient and their correct performance in the activities of daily living. Gait and stability are central axes to analyze and enhance in the elderly patient. Strategies for magnify these qualities are innumerable, although active exercise and electrostimulation comprise the most scientifically developed. Therefore, the objective of this study is to evaluate the effects of an electrostimulation (EE) program applied to the triceps surae in older adults on the temporo-spatial parameters of gait, stability and function.

Study Overview

• Status: Recruiting
• Conditions: Aged
• Intervention / Treatment: Device: Neuromuscular electrical stimulation

Detailed Description

This is a quasi-experimental study with a sample of 13 volunteers. Patients of both genders and over 60 years old will be potential candidates for participating in the study. Volunteers will be invited to participate in the study through social networks and e-mail.

The study will be conducted in 12 experimental sessions on different days and 2 assessment days. During assessment sessions several measurements will be performed, including: balance (will be assessed using a balance tracking system balance plate) function (will be assessed by using the Short Physical Performance Battery) and gait (will be assessed using the Legsys device employing a 4 meter walk test).

The G-Power program (version 3.1.5, Franz Faul, Universität Kiel, Kiel, Germany) was used to perform the one-tailed sample calculation using a previous study . The isometric strenght of gastrocnemius was chosen as the main variable with an effect size of 0.70. The alpha level was set at 5%, and the estimated sampling power was 80%. The software returned a total sample of 13 individuals.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leonardo Intelangelo, MSc; Phone Number: +5493414110506; Email: lintelangelo@ugr.edu.ar
• Study Contact Backup: Name: Iván Roulet Roulet, PT; Phone Number: 5493415060380; Email: iroulet@ugr.edu.ar

Study Locations

• Argentina
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Recruiting
      • University of Gran Rosario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

. To have signed the informed consent.

Exclusion Criteria:

• Surgical history of the lower extremities
• Uncontrolled neurological, metabolic disease
• Uncontrolled cardiac disease
• Uncontrolled respiratory disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Electricalstimulation

Device: Neuromuscular electrical stimulation; As regards the electrodes position, one proximal electrode on the gastrocnemius, which will be located below the popliteal fossa (at least 5cm below it) for a better position on the muscle belly; and one distal electrode, located at least 10 cm from the calcaneus. This protocol will last 20 minutes per session. The placement of the electrodes is as mentioned above, and the parameters to be used will be the following: a stimulation frequency between 35 and 80Hz, a pulse width between 150 and 200 µs, the intensity will be established individually using an intensity that generate a visible contraction of maximum intensity without generating pain. The duration of the contraction will be of 6 seconds with 30 seconds of rest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ankle plantar-flexion strength	The ankle plantar-flexion strength will be measured with a wii balance board with the subject seated. A strap was placed distally on the thigh and passed directly over the external malleolus. The subject was asked to pull against the strap by extending his ankle while pushing with the sole of their foot and trying to lift the heel.	At baseline and 6 weeks later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function	The function was assessed by using the Short Physical Performance Battery. This is a series of 3 tests to assess lower extremity physical function: a 4-meter walk at usual pace, time to complete 5 unassisted chair stands, and 3 standing balance tests. The scores range from 0 (worst performance) to 12 (best performance).	At baseline and 6 weeks later
Function	Function was assessed using the Timed Up and Go test, this test uses the time (in seconds) that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair and sit down while turning 180 degrees.	At baseline and 6 weeks later
Change in balance	Balance will be assessed using a balance tracking system balance plate (Balance Tracking Systems, San Diego, CA). Participants stood on the plate for six testing trials. The first three measurement were made with bipedal stance and eyes closed, for about 30 seconds. The next three assessments were made with monopodal support on the right foot and the las 3 measurements were made with monopodal support on the left foot each monopodal repetition last 15 seconds.	At baseline and 6 weeks later
Change in handgrip strength	The handgrip was assessed using a Jamar dynamometer while the subjects were sited.	At baseline and 6 weeks later
Change in gait speed	The gait speed was assessed by using the time that a person takes to walk 4 meters distance. The test also included an acceleration phase of 2,5 meters, and a deceleration phase of 2,5 meters too.	At baseline and 6 weeks later

Collaborators and Investigators

• Sponsor: University of Gran Rosario

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): August 20, 2024
• Study Completion (Estimated): November 20, 2024

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1820

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No