Electrical Stimulation in Older Adults

Aged Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06046885
• Other study ID #: 1820
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: November 20, 2024

Study information

• Verified date: June 2023
• Source: University of Gran Rosario
• Contact: Iván Roulet Roulet, PT
• Phone: 5493415060380
• Email: iroulet[@]ugr.edu.ar
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 20, 2024
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged

Intervention

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.

Locations

Country	Name	City	State
Argentina	University of Gran Rosario	Rosario	Santa Fe

Sponsors (1)

Lead Sponsor	Collaborator
University of Gran Rosario

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in handgrip strength	The handgrip was assessed using a Jamar dynamometer while the subjects were sited.	At baseline and 6 weeks later
Secondary	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