Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
ID06244511

When to Start Bipedal Exercises in Chronic Ankle Instability: Comparing Early vs. Late Exercise Timing

Led by Istanbul University - Cerrahpasa · Updated on 2025-03-24

40

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

I

Istanbul University - Cerrahpasa

Lead Sponsor

B

Bezmialem Vakif University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Ankle sprains are common musculoskeletal injuries, making up 15-30% of such cases. Many patients experience repeated ankle sprains after an initial injury, and inadequate treatment can lead to chronic ankle instability (CAI) in 30-70% of cases. This research aims to compare the effects of unipedal versus bipedal exercise programs in early rehabilitation for people with CAI, focusing on pain, functional stability, fear avoidance, disease severity, and patient satisfaction. Participants diagnosed with CAI will be randomly assigned to one of two exercise groups: an early bipedal exercise group or a late bipedal exercise group. Both groups will receive supervised proprioceptive, resistive, neuromuscular exercises, and stretching guided by a physiotherapist twice a week for 8 weeks. The early group will use both limbs actively during the first four weeks, while the late group will do so during the last four weeks. Throughout the 24-week study, participants will be assessed for pain using the Visual Analog Scale, functional performance with the Single Leg Hop Test, and fear avoidance with the Tampa Kinesiophobia Scale at multiple time points. Additional measures include ankle instability, joint motion, foot and ankle ability, balance tests, and overall change ratings. Researchers will monitor progress and satisfaction to understand which exercise timing better supports recovery and function in CAI.

CONDITIONS

Brief Title

Bipedal vs. Unipedal Exercises in Chronic Ankle Instability

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented unilateral ankle instability confirmed by clinical exams and MRI if needed
  • History of initial ankle sprain at least 6 months ago
  • Recurrent sense of ankle giving way starting at least 6 months ago and persisting intermittently
Not Eligible

You will not qualify if you...

  • Previous surgery in the lower extremity
  • Organic or non-organic lesions like cartilage injuries or tendon tears
  • Fracture accompanying foot-ankle instability
  • Congenital deformities in foot-ankle
  • Talus osteochondral lesion diagnosis
  • Ankle arthritis diagnosis
  • Medial ligament lesion presence
  • Peripheral neuropathy
  • Additional rheumatological diseases
  • Regular moderate exercise at least 3 days a week in the last 6 months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants undergo supervised proprioceptive, resistive, neuromuscular exercises and stretching under the guidance of a physiotherapist. Exercises are performed twice a week for 8 weeks, with early or late bipedal exercise timing depending on group assignment.

2 visits per week for 8 weeks

Follow-up

Duration - 24 weeks

Participants are assessed for recovery and functional outcomes through various tests and questionnaires over 24 weeks following treatment.

3 visits for assessments over 24 weeks

Trial Site Locations

Total: 1 location

1

Acibadem Mehmet Ali Aydinlar University

Istanbul, Turkey (Türkiye), 34752

Actively Recruiting

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Research Team

A

Ayşenur Erekdağ, MSc

S

Sezen Karabörklü Argut, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Higher frequency of hamstring injuries in elite track and field athletes who had a previous injury to the ankle - a 17 years observational cohort study.

Nikolaos Malliaropoulos, Georgios Bikos, Maria Meke...

https://pubmed.ncbi.nlm.nih.gov/29492109

Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium.

Phillip A Gribble, Eamonn Delahunt, Christopher M Bleakley...

https://pubmed.ncbi.nlm.nih.gov/24377963