Comparing Two Training Frequencies of Balance Training for Chronic Ankle Instability

NCT07612358 | Completed

• 1 other identifier: 2024034H
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two progressive hop-to-stabilization balance (PHSB) training schedules with equal total training volume in people with chronic ankle instability (CAI). Current evidence supports the effectiveness of PHSB training for CAI rehabilitation, but no study has directly compared different training frequencies when total training dose is held constant. Sixty participants with CAI were randomly assigned to three groups: a 4-week group (3 sessions per week, 12 sessions total, n=23), a 6-week group (2 sessions per week, 12 sessions total, n=22), and a waitlist control group (n=12). Each session lasted 20 minutes and followed the standardized PHSB protocol, including single-limb hops to stabilization, hops to stabilization and reach, unanticipated hop to stabilization, and single-limb stance activities with progressive difficulty. The control group received the intervention after study completion. The primary outcomes are sensory organization measured by the Sensory Organization Test (composite score, six condition equilibrium scores, and four sensory ratios for somatosensory, visual, vestibular, and visual preference) and strategy analysis scores, and regional plantar pressure distribution during walking measured by FreeSTEP (peak force normalized to body weight across the first through fifth metatarsal heads, hallux, medial hindfoot, and lateral hindfoot). Secondary outcomes include self-reported ankle function (Cumberland Ankle Instability Tool), dynamic balance (Y-Balance Test and side-hop test), static postural stability during single-leg stance measured by FreeSTEP (center of pressure mean velocity, confidence ellipse area, sway length, anteroposterior and mediolateral standard deviation of COP displacement, and Romberg index calculated as eyes-closed to eyes-open ratio of ellipse area), forefoot-rearfoot and medial-lateral plantar load ratios during walking, ankle range of motion measured by goniometer, and ankle muscle strength assessed by manual muscle testing. This study aims to determine whether different training frequency schedules produce similar or distinct rehabilitation outcomes across sensorimotor, biomechanical, and patient-reported domains, providing evidence for flexible and individualized exercise prescription in CAI management.

Conditions

Chronic Ankle Instability, CAI; Chronic Ankle Instability

Outcome Measures

Primary Outcomes (2)

• Cumberland Ankle Instability Tool (CAIT)

  Self-reported ankle function questionnaire assessing perceived ankle instability during daily and sporting activities. Total score ranges 0-30, with higher scores indicating better ankle stability. A score below 24 indicates chronic ankle instability per International Ankle Consortium criteria. The minimal clinically important difference is 3 points. The Chinese version has demonstrated high internal consistency (Cronbach alpha 0.815) and test-retest reliability (ICC 0.99).

  Baseline (within 1 week before intervention) and post-intervention (within 1 week after completion of the training program)

• Y-Balance Test (YBT)

  Dynamic balance assessment measuring maximum reach distance in three directions (anterior, posteromedial, posterolateral) during single-leg stance on the affected limb. Reach distances were normalized to limb length and expressed as percentage. Three trials per direction with the best value selected, and the average of three directions used as the final score. Higher scores indicate better dynamic balance.

  Baseline (within 1 week before intervention) and post-intervention (within 1 week after completion of the training program)

Secondary Outcomes (9)

• SOT Sensory Ratios

  Baseline and post-intervention (within 1 week after completion of the training program)

• SOT Balance Performance

  Baseline and post-intervention (within 1 week after completion of the training program)

• Regional Plantar Pressure Distribution During Walking

  Baseline and post-intervention (within 1 week after completion of the training program)

• Static Postural Stability Parameters During Single-Leg Stance

  Baseline and post-intervention (within 1 week after completion of the training program)

• Romberg Index

  Baseline and post-intervention (within 1 week after completion of the training program)

Study Arms (3)

4-Week PHSB Training Group

EXPERIMENTAL

Participants received progressive hop-to-stabilization balance training 3 times per week for 4 weeks (12 sessions total, 20 minutes per session). The training protocol included four components: single-limb stance activities with 7 progressive difficulty levels under eyes-open and eyes-closed conditions, single-limb hops to stabilization in four directions at three distances (45cm, 68cm, 91cm), hops to stabilization and reach with 7 progressive levels, and unanticipated hop to stabilization using a 9-grid system with 7 progressive levels. Training sessions were scheduled with approximately equal inter-session intervals (48-72 hours between sessions). n=23.

Behavioral: PHSB Training - High Frequency Short Duration

6-Week PHSB Training Group

EXPERIMENTAL

Participants received the same progressive hop-to-stabilization balance training protocol as the 4-week group, but at a frequency of 2 times per week for 6 weeks (12 sessions total, 20 minutes per session). Training content, progression criteria, and difficulty levels were identical to the 4-week group. Training sessions were scheduled with approximately equal inter-session intervals (72-96 hours between sessions).n=22.

Behavioral: PHSB Training - Low Frequency Long Duration

Waitlist Control Group

NO INTERVENTION

Participants received no therapeutic intervention during the study period. Health education was provided during the waiting period. All control group participants were offered the PHSB training program upon completion of the study to ensure ethical treatment. n=12.

Interventions

PHSB Training - High Frequency Short Duration BEHAVIORAL

Standardized progressive hop-to-stabilization balance training performed 3 times per week for 4 weeks (12 sessions, 20 minutes per session, 240 minutes total). Training sessions were scheduled with approximately equal inter-session intervals (48-72 hours). The protocol consisted of four components with progressive difficulty levels: (1) single-limb stance activities under eyes-open and eyes-closed conditions on firm and foam surfaces with 7 levels, (2) single-limb hops to stabilization in four directions at three distances (45, 68, 91 cm) with 7 levels, (3) hops to stabilization and reach with 7 levels, and (4) unanticipated hop to stabilization using a numbered 9-grid system with 7 levels. Progression occurred when participants completed a level without errors. n=23.

4-Week PHSB Training Group

PHSB Training - Low Frequency Long Duration BEHAVIORAL

Identical progressive hop-to-stabilization balance training protocol as Intervention 1, performed 2 times per week for 6 weeks (12 sessions, 20 minutes per session, 240 minutes total). Training sessions were scheduled with approximately equal inter-session intervals (72-96 hours). Training content, progression criteria, difficulty levels, and exercise components were the same as the 4-week protocol. The only difference was the distribution of training sessions across a longer period at a lower weekly frequency. n=22.

6-Week PHSB Training Group

Eligibility Criteria

• Age: 16 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• History of at least one lateral ankle sprain with inflammatory signs (swelling, pain) and inability to bear weight on the affected side for at least one day after injury, per International Ankle Consortium criteria.
• At least two episodes of giving way, recurrent ankle sprains, or perceived ankle instability within 6 months prior to enrollment.
• Time since first ankle sprain greater than 12 months.
• Time since most recent ankle sprain greater than 3 months.
• No history of fracture or surgery in either lower extremity.
• No other injuries causing inability to bear weight on either lower extremity within the past 3 months.
• Cumberland Ankle Instability Tool (CAIT) score of 24 or below
• Physically active: engaging in at least 30 minutes of moderate or higher intensity physical activity on at least 3 days per week.
• Age 16-49 years.
• Willing to provide written informed consent -

You may not qualify if:

• History of lower extremity surgery or lower extremity fracture affecting lower limb function
• Acute ankle sprain within 6 weeks prior to enrollment
• Foot or ankle immobilization for more than 48 hours within the past 6 months
• Neurological, vestibular, or other medical conditions affecting muscle strength or proprioceptive function
• Currently receiving other rehabilitation treatment for the ankle -

Sponsors & Collaborators

• University of Utah: lead
• Beijing Sport University: collaborator

Study Sites (1)

Beijing Sport University

Beijing, 100084, China

Location

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: Graduate Research Assistant

Model Details: Participants were randomly assigned in a 2:2:1 ratio to one of three parallel groups: a 4-week high-frequency PHSB training group, a 6-week low-frequency PHSB training group, or a waitlist control group. The two training groups received the same total training volume (12 sessions, 20 minutes each, 240 minutes total) but differed in weekly frequency and overall duration. The control group received no intervention during the study period and was offered the training upon study completion.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 28, 2026
• Study Start: November 8, 2023
• Primary Completion: January 17, 2025
• Study Completion: March 16, 2025
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

CN (1)