Balance and Proprioception Training Program in Patients With Chronic Ankle Sprains

NCT05920044 | Unknown

• 1 other identifier: 012/Ank-01200021
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ankle Sprains

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Changes in Balance

  Changes in balance at baseline, 8 weeks, and 16 weeks follow up

• Changes in Proprioception

  Changes in proprioception at baseline, 8 weeks, and 16 weeks follow up

• Incidence of Recurrent Ankle Sprains

  From post-intervention at 8 weeks to the end of the follow-up period at 16 weeks

Study Arms (2)

Intervention Group:

EXPERIMENTAL

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

Other: balance and proprioception training program.

Control group

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

balance and proprioception training program. OTHER

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 Group:

Usual care OTHER

Participants will continue their usual care, including general strength and flexibility exercises. No specific balance and proprioception training will be provided.

Control group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: June 27, 2023
• Primary Completion: June 27, 2024
• Study Completion: July 12, 2024
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)