- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06934629
Efficacy of Tecar Device With Exercises in Ankle Sprain (TECAR)
Effect of Tecar Therapy During Active Exercises on Dynamic Balance in Acute Ankle Sprain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alexandria Governorate
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Alexandria, Alexandria Governorate, Egypt
- Andalusia hospital in Alexandria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TECAR therapy group
traditional therapeutic exercises for ankle sprain and TECAR therapy application during exercises .
|
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.
|
|
Active Comparator: Conventional therapy group
traditional therapeutic exercises for ankle sprain
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2.pain
Time Frame: from enrollment to the end of treatment at 4 weeks.
|
using Numerical pain rating scale (NPRS)
|
from enrollment to the end of treatment at 4 weeks.
|
|
1.ankle dynamic balance.
Time Frame: from enrollment to the end of treatment at 4 weeks.
|
using Y-Balance Test (YBT)
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from enrollment to the end of treatment at 4 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3. proprioception
Time Frame: from enrollment to the end of treatment at 4 weeks.
|
using digital inclinometer
|
from enrollment to the end of treatment at 4 weeks.
|
|
4. Daily Function
Time Frame: from enrollment to the end of treatment at 4 weeks.
|
Using FAAM questionnaire
|
from enrollment to the end of treatment at 4 weeks.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005596
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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