AgedNCT06046885
Electrical Stimulation in Older Adults
A study testing Neuromuscular electrical stimulation in people with Aged, run by University of Gran Rosario at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged
- What is being tested?
- Neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteArgentina
- Study dates
- 20 Jun 2023to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- . To have signed the informed consent.
Who cannot join
- Surgical history of the lower extremities
- Uncontrolled neurological, metabolic disease
- Uncontrolled cardiac disease
- Uncontrolled respiratory disease
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
University of Gran Rosario
Rosario, Santa Fe Province, 2000
About this study
Official title: 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.
Read the 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
- Being tested
- Neuromuscular electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electricalstimulation | Experimental | Not described Receives: Device: Neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and 6 weeks later
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: At baseline and 6 weeks later
Change in handgrip strength
The handgrip was assessed using a Jamar dynamometer while the subjects were sited.
Measured: 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.
Measured: At baseline and 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start20 Jun 2023
- Primary completion20 Aug 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gran Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Roulet, University of Gran Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046885
- Sponsor's protocol ID
- 1820
- Status last verified
- Jun 2023
- First submitted
- 27 Jun 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Neuromuscular Electrostimulation Protocol on the Triceps Surae in Older Adults
- ClinicalTrials.gov ID
- NCT06046885
- Acronym / sponsor ID
- 1820
- Conditions
- Aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Gran RosarioUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electricalstimulation | Experimental | Device: Neuromuscular electrical stimulation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- . To have signed the informed consent.
Key exclusion criteria (4 listed)
- Surgical history of the lower extremities
- Uncontrolled neurological, metabolic disease
- Uncontrolled cardiac disease
- Uncontrolled respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationAs 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. | Device | Electricalstimulation |
Primary outcome
Change in ankle plantar-flexion strength
Time frame: At baseline and 6 weeks later
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.
5 secondary outcomes
Function
Time frame: At baseline and 6 weeks later
Function
Time frame: At baseline and 6 weeks later
Change in balance
Time frame: At baseline and 6 weeks later
Change in handgrip strength
Time frame: At baseline and 6 weeks later
Change in gait speed
Time frame: At baseline and 6 weeks later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation in people with Aged, run by University of Gran Rosario at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iván Roulet Roulet, PT (5493415060380, iroulet@ugr.edu.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ankle plantar-flexion strength (time frame: At baseline and 6 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.