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CompletedNCT07906002Updated Oct 30, 2026

Virtual Reality-Integrated Rehabilitation Versus Conventional Balance Therapy Following Ankle Fracture

An interventional study of Virtual Reality Balance System (VR-Training) and Standard Physical Therapy (Conventional Exercise) in Ankle Fractures, Joint Stiffness and Postural Balance, sponsored by Dr Aneeqa Sultan. Completed at 2 sites in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Dr Aneeqa Sultan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Apr 2026, registered Oct 2026).
Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study compares virtual reality-based balance training with conventional balance therapy in adults recovering from an ankle fracture after a period of immobilization.

A total of 22 adults aged 18-60 years who were medically cleared to bear full weight on the affected leg participated in the study. Participants were randomly assigned to two groups: one received virtual reality-based balance training, and the other received conventional balance exercises.

Both groups received supervised rehabilitation sessions lasting 30 minutes, three to five times per week, for six to eight weeks. The virtual reality group performed interactive weight-shifting and balance activities with visual feedback, while the conventional therapy group performed exercises such as single-leg standing, balance board activities, BOSU ball exercises, and ankle strengthening.

Balance and ankle movement were assessed before and after the intervention. The study evaluated balance using the Berg Balance Scale, dynamic postural control using the Star Excursion Balance Test, and active ankle dorsiflexion range of motion using a goniometer. The study was designed to compare the outcomes of the two rehabilitation approaches following ankle fracture.

Read the detailed description

Background

Ankle fractures are common lower-limb injuries that may require surgical fixation or conservative management with immobilization. Following immobilization, patients may experience ankle joint stiffness, reduced muscle strength, impaired proprioception, decreased dorsiflexion range of motion, and difficulties with balance and walking. These problems can affect functional recovery and postural stability.

Conventional physical therapy commonly includes balance exercises, single-leg standing, balance board activities, and ankle strengthening. Virtual reality (VR)-based rehabilitation offers interactive exercises and visual feedback that may help patients practice controlled weight shifting and dynamic balance activities.

Study Objective

This study compared the effectiveness of virtual reality-integrated rehabilitation with conventional balance therapy in adults recovering from ankle fractures following immobilization.

Study Design and Participants

This was a single-blind randomized controlled trial involving 22 adults aged 18-60 years recruited from orthopedic rehabilitation departments in Lahore, Pakistan. Participants had medically confirmed closed malleolar ankle fractures, managed surgically or conservatively, and had been cleared for full weight-bearing ambulation. Participants were randomly allocated in a 1:1 ratio to two groups, with 11 participants in each group. Outcome assessors were blinded to group allocation.

Intervention Group: Virtual Reality-Based Balance Training

Participants received supervised rehabilitation using a virtual reality balance system. Each session lasted 30 minutes and included 15 minutes of dynamic weight-shifting exercises with visual center-of-gravity feedback, followed by 15 minutes of interactive balance tasks involving target matching, obstacle avoidance, and multidirectional postural adjustments. Exercise difficulty was adjusted according to participant performance.

Comparison Group: Conventional Balance Therapy

Participants received a supervised conventional balance therapy program lasting 30 minutes per session. Exercises included static single-leg standing, tandem standing, wobble board balancing, BOSU ball stability exercises, and ankle strengthening with resistance bands. Exercise difficulty was progressed by the therapist according to clinical tolerance.

Both groups received treatment three to five days per week for six to eight weeks, with approximately 20-24 sessions.

Outcome Measures

Outcomes were assessed at baseline and immediately after the intervention.

  1. Berg Balance Scale (BBS): Used to assess balance and functional performance across 14 tasks. Total scores range from 0 to 56, with higher scores indicating better balance performance.
  2. Star Excursion Balance Test (SEBT): Used to evaluate dynamic postural control, including posteromedial reach and the overall composite score. Reach distances were normalized to leg length and expressed as percentages.
  3. Active Ankle Dorsiflexion Range of Motion: Measured in degrees using a universal goniometer to assess active sagittal-plane ankle movement.

Statistical Analysis

Within-group changes were assessed using the Wilcoxon signed-rank test, while between-group comparisons were performed using the Mann-Whitney U test.

Study Purpose

The study was designed to compare changes in balance, dynamic postural control, and ankle dorsiflexion range of motion following virtual reality-based rehabilitation and conventional balance therapy in adults recovering from ankle fractures.

02

Conditions studied

  • Ankle Fractures
  • Joint Stiffness
  • Postural Balance
  • Proprioception, Postural Balance

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Keywords

  • Virtual Reality
  • Ankle Fracture
  • Balance Training
  • Berg Balance Scale
  • Star Excursion Balance Test
  • Range of Motion
  • Rehabilitation
03

In context

Ankle Fractures

202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.

This study's enrollment of 22 is below the median of 90 across 150 interventional studies indexed under Ankle Fractures.

Browse Ankle Fractures studies →

Lead sponsor

Dr Aneeqa Sultan is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18-60 years, of any sex.
  • Individuals with medically confirmed closed malleolar ankle fractures managed surgically or conservatively.
  • Individuals who have completed immobilization and have been medically cleared for full weight-bearing.
  • Individuals who are ambulatory, with or without an assistive device, and have minimal pain.
  • Individuals willing to provide and comply with the study protocol.

Exclusion criteria

Exclusion Criteria:

  • Individuals with neurological disorders affecting balance or mobility.
  • Individuals with severe, uncorrectable visual impairment or active vestibular disorders.
  • Individuals with infection, fracture non-union, or severe pain.
  • Individuals with cognitive impairment that prevents understanding or following instructions.
  • Individuals with photosensitive epilepsy or severe motion sickness.
  • Individuals with concurrent major lower-limb injuries.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    VR-Based Balance Training

    Participants complete interactive virtual reality-integrated balance training using the VR-Balance System. Sessions last 30 minutes, 3 to 5 days per week for 6 to 8 weeks (total 20-24 sessions). The program includes 15 minutes of guided center-of-gravity weight shifting with visual feedback and 15 minutes of gamified multidirectional dynamic balance tasks.

    Behavioral: Virtual Reality Balance System (VR-Training)

  • Active comparator
    Conventional Balance Therapy

    Participants receive a standardized conventional balance physical therapy program. Sessions last 30 minutes, 3 to 5 days per week for 6 to 8 weeks (total 20-24 sessions). Exercises consist of static single-leg stance, wobble board balancing, BOSU ball stability exercises, and TheraBand lower-limb strengthening.

    Behavioral: Standard Physical Therapy (Conventional Exercise)

Interventions

  • BehavioralVirtual Reality Balance System (VR-Training)

    Supervised digital feedback training program. Participants stand on an integrated sensor platform facing an interactive screen displaying center-of-mass displacement. Exercises involve target matching, obstacle dodging, and controlled postural weight shifts. Adaptive difficulty scales with user performance to enhance motor recalibration.

  • BehavioralStandard Physical Therapy (Conventional Exercise)

    Supervised manual balance therapy. Interventions include single-leg stance drills, tandem standing, balance board tilting, BOSU ball balancing, and manual resistance ankle exercises. Difficulty is manually progressed by the physical therapist based on clinical tolerance.

06

What researchers measure

Primary outcomes

  1. Change in Static Balance Measured by the Berg Balance Scale (BBS)

    The Berg Balance Scale assesses balance and functional performance across 14 standardized tasks. Total scores range from 0 to 56, with higher scores indicating better balance control. Change from baseline to post-intervention will be evaluated.

    Time frame: Baseline and immediately after the 6-to-8-week intervention

  2. Change in Dynamic Postural Control Measured by the Star Excursion Balance Test (SEBT)

    The Star Excursion Balance Test assesses dynamic balance using posteromedial reach and the overall composite score. Reach distance is normalized to leg length and expressed as a percentage. Higher percentages indicate better dynamic stability. Change from baseline to post-intervention will be evaluated.

    Time frame: Baseline and immediately after the 6-to-8-week intervention

Secondary outcomes

  1. Change in Active Ankle Dorsiflexion Range of Motion

    Active weight-bearing ankle dorsiflexion range of motion is measured in degrees using a universal goniometer. An increase in degrees indicates improved ankle dorsiflexion. Change from baseline to post-intervention will be evaluated.

    Time frame: Baseline and immediately after the 6-to-8-week intervention

07

Study locations

2 sites
  • Ghurki Trust Teaching Hospital
    Lahore, Punjab Province, Pakistan
  • Mayo Hospital Lahore
    Lahore, Punjab Province, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2026 to primary completion in Aug 2026, 4 months.

Of 69 non-industry interventional studies with no phase under Ankle Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's 4 months is below that.

Counting every sponsor, half of 72 studies reached it within 45 months; a quarter within 23 and three quarters within 61.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2026
First posted
Oct 30, 2026
StartActual
Apr 10, 2026
Primary completionActual
Aug 20, 2026
CompletionActual
Sep 15, 2026
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07906002
Lead sponsor
Dr Aneeqa Sultan
Collaborators
Mayo Hospital Lahore
Responsible party
Dr Aneeqa Sultan (Principal Investigator, Superior University) — Sponsor-investigator
First posted
Oct 30, 2026
Start date
Apr 10, 2026
Primary completion
Aug 20, 2026
Completion
Sep 15, 2026
Last update
Oct 30, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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