NCT06343207

Brief Summary

To examine the acute effect of percussive therapy on peak calf muscle activation during standing heel raise in subjects with and without chronic ankle instability (CAI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 22, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 21, 2024

Last Update Submit

March 26, 2024

Conditions

Keywords

surface electromyographyankle injurylower limb injury

Outcome Measures

Primary Outcomes (1)

  • Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability.

    Recorded and filtered sEMG data by Trigno Sensors (Delsys Inc., Natick, USA) underwent rectification to absolute values and enveloped by window length (root mean squared; RMS) of 200 ms (Farfan et al., 2010). For EMG activation normalization of DOM and NON lower limb individually, peak RMS muscle activity during flamingo tests (for dominant and nondominant individually) was used and applied to represent the mean RMS in percentages of sEMG activity during each test and each lower limb (%RMSmax).

    1 week

Study Arms (4)

CAI PT

EXPERIMENTAL

Chronic ankle instability patient + percussive therapy intervention

Device: Percussive massage gun therapy

CAI NOPT

NO INTERVENTION

Chronic ankle instability patient + NO percussive therapy intervention (control)

CON PT

EXPERIMENTAL

Healthy subjects + percussive therapy intervention

Device: Percussive massage gun therapy

CON NOPT

NO INTERVENTION

Healthy subjects + NO percussive therapy intervention

Interventions

Between pre and post-test, there was a one and half minute period during which each participant were in a prone position on a medical examination bed. The experimental PT groups received a 30-second triceps surae massage on each limb, while the control group maintained the same prone position without massage. The massage gun was set to 2100bpm and 1 bar of surface pressure was indicated by the device. The massage gun movement was performed according to the manufactu'er's instructions.

Also known as: TheraGun
CAI PTCON PT

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • CAI group - at least two ankle luxation or ankle distortions in the last 2 years as reported by a physician.
  • Healthy group - healthy

You may not qualify if:

  • paraplegia,
  • women in advanced stages of pregnancy
  • feverish or acute inflammatory diseases within 7 days before the measurement
  • current or healed rupture of m. gastrocnemius, m. soleus, tendo calcaneus
  • purulent, fungal diseases, burns, scalds, varices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical education and sport, Charles University

Prague, 16252, Czechia

Location

MeSH Terms

Conditions

Ankle InjuriesLeg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Lukas Michal, MSc.

    Department of Pathophysiology, Charles University, Second Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc. Lukas Michal

Study Record Dates

First Submitted

March 21, 2024

First Posted

April 2, 2024

Study Start

November 22, 2022

Primary Completion

February 2, 2023

Study Completion

February 2, 2023

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations