Efficacy of Balance Training by BBS on Gait Parameters and Balance in Patients With RLAS

Efficacy of Balance Training by Biodex Balance System on Gait Parameters and Balance in Patients With RLAS

This study will be conducted to find out the effect of adding balance training on gait parameters, balance, and Sensory Interaction

Study Overview

• Status: Completed
• Conditions: Ankle Sprains
• Intervention / Treatment: Device: Biodex Balance System; Other: specific physical therapy exercise program

Detailed Description

LAS are not benign injuries. As many as 4 in 10 individuals will develop chronic ankle instability (CAI) after a first-time sprain, More than half of patients with osteoarthritis (OA) of the ankle report a history of a sport-related ankle injury, and 85% of those are LAS.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient will be referred to the outpatient clinic of the orthopedic department, Faculty of physical therapy, MTI University. with a confirmed diagnosis of recurrent Lateral ankle sprain grade II
• Subjects will be excluded if they had one of the following criteria:

Previous musculoskeletal injury to the lower limb or lumbar spine including a fracture, a sprain, or an unstable joint other than the injured ankle.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Experimental Group; Group (A) twenty-five patients will receive biodex balance training	Device: Biodex Balance System; Subjects will receive several unique training modules using biodex; Other Names: BBS; Other: specific physical therapy exercise program; Subjects will receive recommended PT program
Other: Controlled Group; twenty-five patients will receive a physical therapy exercise protocol	Other: specific physical therapy exercise program; Subjects will receive recommended PT program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cadence	Change in Cadence measurements using Walkway Gait System.	Before Treatment and after 6 weeks of treatment
Gait time	Change in Gait time measurements using Walkway Gait System.	Before Treatment and after 6 weeks of treatment
Clinical Test of Sensory Integration	Change in Clinical Sensory Integration test measurements using Biodex balance System.	Before Treatment and after 6 weeks of treatment

Collaborators and Investigators

• Sponsor: MTI University
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: RLAS

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