Balance and Proprioception Training Program in Patients With Chronic Ankle Sprains

Sponsor

Ahram Canadian University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05920044

Collaborator

(none)

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Sprains	Other: balance and proprioception training program. Other: Usual care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 27, 2023

Anticipated Primary Completion Date :

Jun 27, 2024

Anticipated Study Completion Date :

Jul 12, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al Ḩayy Ath Thāmin	Giza	Egypt	3221405

Sponsors and Collaborators

Ahram Canadian University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University

ClinicalTrials.gov Identifier:

NCT05920044

Other Study ID Numbers:

012/Ank-01200021

First Posted:

Jun 27, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sprains and Strains

Ankle Injuries

Study Results

No Results Posted as of Jun 27, 2023