Electrical Stimulation in Older Adults

NCT ID: NCT06046885

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2024-11-20

Brief 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.

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.

Conditions

Aged

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electricalstimulation

Group Type: EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Gran Rosario

OTHER

Sponsor Role: lead

Responsible Party

Ivan Roulet

PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Gran Rosario

Rosario, Santa Fe Province, Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Iván Roulet Roulet, PT

Role: CONTACT

iroulet@ugr.edu.ar

5493415060380

Leonardo Intelangelo, MSc

Role: CONTACT

lintelangelo@ugr.edu.ar

+5493414110506

Other Identifiers

1820

Identifier Type: -

Identifier Source: org_study_id