NCT06046885

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

September 21, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

June 27, 2023

Last Update Submit

September 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Function

    At baseline and 6 weeks later

  • Function

    At baseline and 6 weeks later

  • Change in balance

    At baseline and 6 weeks later

  • Change in handgrip strength

    At baseline and 6 weeks later

  • Change in gait speed

    At baseline and 6 weeks later

Study Arms (1)

Electricalstimulation

EXPERIMENTAL
Device: Neuromuscular electrical stimulation

Interventions

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.

Electricalstimulation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To have signed the informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gran Rosario

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Central Study Contacts

Iván Roulet Roulet, PT

CONTACT

Leonardo Intelangelo, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT

Study Record Dates

First Submitted

June 27, 2023

First Posted

September 21, 2023

Study Start

June 20, 2023

Primary Completion

August 20, 2024

Study Completion

November 20, 2024

Last Updated

September 21, 2023

Record last verified: 2023-06

Locations