NCT06934629

Brief Summary

The goal of this clinical trial is to evaluate the effect of applying TECAR therapy during active therapeutic exercises on pain, ankle dynamic balance, proprioception, and daily function in patients with acute ankle sprain. the main questions it aims to answer are:

  • Does there is a significant effect of applying TECAR therapy during active exercise after acute lateral ankle sprain on Pain?
  • Does there is a significant effect of applying TECAR therapy during active exercise after acute lateral ankle sprain on balance?
  • Does there is a significant effect of applying TECAR therapy during active exercise after acute lateral ankle sprain on proprioception?
  • Does there is a significant effect of applying TECAR therapy during active exercise after acute lateral ankle sprain on daily function? The patients will be randomly divided into two groups. The control group (A) will receive the conventional therapy which is ankle and subtalar ROM in a pain-free range, calf muscle stretch, ankle strengthening exercises against resistance bands in all directions, weight-bearing exercise, forward lunges, bilateral and unilateral squats, bilateral and unilateral heel raises against bodyweight resistance, and balance training. The experiment group (B) will receive conventional therapy with TECAR therapy application during active therapeutic exercises. Treatment will be for 4 weeks with 2 sessions per week. TECAR application will be 20 mins per session (10 mins capacitive and 10 mins resistive). To the best of the researchers' knowledge, no study has proved the effects of applying TECAR therapy during active therapeutic exercises after an acute lateral ankle sprain has yet been done. Thus, the purpose of the present study was to prove if there an effect of applying TECAR therapy during active therapeutic exercises included in the conventional physiotherapy (PRICE with therapeutic exercises) and conventional physiotherapy alone on pain, ankle dynamic balance, proprioception, and daily function in subjects with an acute lateral ankle sprain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

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

December 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 2, 2025

Last Update Submit

April 10, 2026

Conditions

Keywords

Ankle painankle dynamic balanceAnkle proprioceptionAnkle daily functionTECARtherapy

Outcome Measures

Primary Outcomes (2)

  • 1.ankle dynamic balance.

    using Y-Balance Test (YBT)

    from enrollment to the end of treatment at 4 weeks.

  • 2.pain

    using Numerical pain rating scale (NPRS)

    from enrollment to the end of treatment at 4 weeks.

Secondary Outcomes (2)

  • 3. proprioception

    from enrollment to the end of treatment at 4 weeks.

  • 4. Daily Function

    from enrollment to the end of treatment at 4 weeks.

Study Arms (2)

TECAR therapy group

EXPERIMENTAL

traditional therapeutic exercises for ankle sprain and TECAR therapy application during exercises .

Device: TECAR therapy

Conventional therapy group

ACTIVE COMPARATOR

traditional therapeutic exercises for ankle sprain

Other: therapeutic exercises

Interventions

TECAR application will be 20 mins per session (10 mins capacitive and 10 mins resistive) during ankle and subtalar ROM in a pain-free range, calf muscle stretch, ankle strengthening exercises against resistance bands in all directions, weight-bearing exercise, forward lunges, bilateral and unilateral squats, bilateral and unilateral heel raises against bodyweight resistance, and balance training.

TECAR therapy group

the conventional therapy which is ankle and subtalar ROM in a pain-free range, calf muscle stretch, ankle strengthening exercises against resistance bands in all directions, weight-bearing exercise, forward lunges, bilateral and unilateral squats, bilateral and unilateral heel raises against bodyweight resistance, and balance training.

Conventional therapy group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Gender will be male and female.
  • Age from 20-40 years old.
  • Grade \| and \|\| lateral ankle sprain.
  • Patients who will be diagnosed and referred by orthopedic surgeon.
  • acute stage of lateral ankle sprain.
  • BMI ≤ 30.
  • Positive confirming tests.

You may not qualify if:

  • Ankle fractures such as talus bone fracture, tibia fracture, ankle dislocation.
  • Unwilling to continue treatment.
  • Contraindications to use TECAR therapy, such as pregnancy, the presence of malignant tissue, tumors, in the ankle, and electrical devices implanted in the body.
  • Grade \|\|\| ankle sprain.
  • Systematic diseases such as rheumatoid arthritis.
  • Recently received intra-steroid injection
  • Pain exacerbation during the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andalusia hospital in Alexandria

Alexandria, Alexandria Governorate, Egypt

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Treatment will be for 4 weeks with 2 sessions per week. TECAR application will be 20 mins per session (10 mins capacitive and 10 mins resistive) during ankle and subtalar ROM in a pain-free range, calf muscle stretch, ankle strengthening exercises against resistance bands in all directions, weight-bearing exercise, forward lunges, bilateral and unilateral squats, bilateral and unilateral heel raises against bodyweight resistance, and balance training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident physiotherapist registered for master degree

Study Record Dates

First Submitted

April 2, 2025

First Posted

April 18, 2025

Study Start

December 15, 2024

Primary Completion

May 30, 2025

Study Completion

July 30, 2025

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations