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Balance and Proprioception Training Program in Patients With Chronic Ankle Sprains

Primary Purpose

Ankle Sprains

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
balance and proprioception training program.
Usual care
Sponsored by
Ahram Canadian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group:

Control group

Arm Description

Participants will receive an eight-week individualized balance and proprioception training program.

Participants will continue their usual care, including general strength and flexibility exercises.

Outcomes

Primary Outcome Measures

Changes in Pain intensity
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS)
Changes in Functional Ability
Functional ability will be assessed using the Foot and Ankle Ability Measure (FAAM)

Secondary Outcome Measures

Changes in Balance
Balance will be assessed using the Star Excursion Balance Test (SEBT)
Changes in Proprioception
Proprioception will be measured using the joint position sense test with an ankle electrogoniometer
Incidence of Recurrent Ankle Sprains
Incidence of recurrent ankle sprains during the follow-up period will be recorded

Full Information

First Posted
June 16, 2023
Last Updated
June 16, 2023
Sponsor
Ahram Canadian University
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1. Study Identification

Unique Protocol Identification Number
NCT05920044
Brief Title
Balance and Proprioception Training Program in Patients With Chronic Ankle Sprains
Official Title
The Effects of an Individualized Balance and Proprioception Training Program on Pain and Function in Patients With Chronic Ankle Sprains: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Anticipated)
Primary Completion Date
June 27, 2024 (Anticipated)
Study Completion Date
July 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group:
Arm Type
Experimental
Arm Description
Participants will receive an eight-week individualized balance and proprioception training program.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants will continue their usual care, including general strength and flexibility exercises.
Intervention Type
Other
Intervention Name(s)
balance and proprioception training program.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Participants will continue their usual care, including general strength and flexibility exercises. No specific balance and proprioception training will be provided.
Primary Outcome Measure Information:
Title
Changes in Pain intensity
Description
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS)
Time Frame
Changes in Pain intensity at baseline, 8 weeks, and 16 weeks follow up
Title
Changes in Functional Ability
Description
Functional ability will be assessed using the Foot and Ankle Ability Measure (FAAM)
Time Frame
Changes in Functional ability at baseline, 8 weeks, and 16 weeks follow up
Secondary Outcome Measure Information:
Title
Changes in Balance
Description
Balance will be assessed using the Star Excursion Balance Test (SEBT)
Time Frame
Changes in balance at baseline, 8 weeks, and 16 weeks follow up
Title
Changes in Proprioception
Description
Proprioception will be measured using the joint position sense test with an ankle electrogoniometer
Time Frame
Changes in proprioception at baseline, 8 weeks, and 16 weeks follow up
Title
Incidence of Recurrent Ankle Sprains
Description
Incidence of recurrent ankle sprains during the follow-up period will be recorded
Time Frame
From post-intervention at 8 weeks to the end of the follow-up period at 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Balance and Proprioception Training Program in Patients With Chronic Ankle Sprains

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