Balance and Proprioception Training Program in Patients With Chronic Ankle Sprains

The Effects of an Individualized Balance and Proprioception Training Program on Pain and Function in Patients With Chronic Ankle Sprains: A Randomized Controlled Trial

To examine the effects of an individualized balance and proprioception training program on pain, function, and the risk of recurrent ankle sprains.

Study Overview

• Status: Recruiting
• Conditions: Ankle Sprains
• Intervention / Treatment: Other: balance and proprioception training program.; Other: Usual care

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie, Ph.d; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18-55 years
• History of at least two ankle sprains within the last 12 months
• Presence of ankle instability symptoms, such as recurrent giving way or chronic pain

Exclusion Criteria:

• Acute ankle injury within the last six weeks
• Lower extremity fracture within the last six months
• Other musculoskeletal or neurological disorders affecting the lower extremity
• Inability to comply with study requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group: Participants will receive an eight-week individualized balance and proprioception training program.	Other: balance and proprioception training program.; The program will include exercises focused on improving ankle stability and joint position sense, such as single-leg stance, wobble board, and resistance band exercises. Participants will attend two supervised sessions per week and perform home-based exercises 3-4 times per week. Progression of exercises will be individualized based on participant performance and tolerance.
Active Comparator: Control group; Participants will continue their usual care, including general strength and flexibility exercises.	Other: Usual care; Participants will continue their usual care, including general strength and flexibility exercises. No specific balance and proprioception training will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pain intensity	Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS)	Changes in Pain intensity at baseline, 8 weeks, and 16 weeks follow up
Changes in Functional Ability	Functional ability will be assessed using the Foot and Ankle Ability Measure (FAAM)	Changes in Functional ability at baseline, 8 weeks, and 16 weeks follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Balance	Balance will be assessed using the Star Excursion Balance Test (SEBT)	Changes in balance at baseline, 8 weeks, and 16 weeks follow up
Changes in Proprioception	Proprioception will be measured using the joint position sense test with an ankle electrogoniometer	Changes in proprioception at baseline, 8 weeks, and 16 weeks follow up
Incidence of Recurrent Ankle Sprains	Incidence of recurrent ankle sprains during the follow-up period will be recorded	From post-intervention at 8 weeks to the end of the follow-up period at 16 weeks

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Estimated): June 27, 2023
• Primary Completion (Estimated): June 27, 2024
• Study Completion (Estimated): July 12, 2024

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: 012/Ank-01200021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No