Ankle FracturesNCT07906002
Virtual Reality-Integrated Rehabilitation Versus Conventional Balance Therapy Following Ankle Fracture
A study testing Virtual Reality Balance System (VR-Training) and Standard Physical Therapy (Conventional Exercise) in people with Ankle Fractures and Joint Stiffness, run by Dr Aneeqa Sultan at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ankle Fractures, Joint Stiffness, Postural Balance
- What is being tested?
- Virtual Reality Balance System (VR-Training) and Standard Physical Therapy (Conventional Exercise)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesPakistan
- Study dates
- 10 Apr 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 informed consent and comply with the study protocol.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Ghurki Trust Teaching Hospital
Lahore, Punjab Province
Mayo Hospital Lahore
Lahore, Punjab Province
About this study
Official title: Effectiveness of Virtual Reality-Integrated Rehabilitation Versus Conventional Balance Therapy Following Ankle Fracture: A Randomized Controlled Trial
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.
Read more
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.
- 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.
- 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.
- 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.
- Being tested
- Virtual Reality Balance System (VR-Training), Standard Physical Therapy (Conventional Exercise)
- Keywords
- Virtual Reality, Ankle Fracture, Balance Training, Berg Balance Scale, Star Excursion Balance Test, Range of Motion, Rehabilitation
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Balance System (VR-Training)Behavioural
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.
Standard Physical Therapy (Conventional Exercise)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VR-Based Balance Training | Experimental | 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. Receives: Behavioral: Virtual Reality Balance System (VR-Training) |
| Conventional Balance Therapy | Active comparator | 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. Receives: Behavioral: Standard Physical Therapy (Conventional Exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after the 6-to-8-week intervention
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.
Measured: 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.
Measured: Baseline and immediately after the 6-to-8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start10 Apr 2026
- Primary completion20 Aug 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a parallel-group design in which participants were randomly assigned to one of two groups. Group A received virtual reality-based balance training, while Group B received conventional balance therapy. Both groups underwent supervised rehabilitation sessions for 6 to 8 weeks.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Aneeqa Sultan
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Hospital Lahore
- Responsible party
- Sponsor-investigator, Dr Aneeqa Sultan, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906002
- Sponsor's protocol ID
- SU91-MSRSW-F24-030
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality-Integrated Rehabilitation Versus Conventional Balance Therapy Following Ankle Fracture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07906002
- Acronym / sponsor ID
- SU91-MSRSW-F24-030
- Keywords
- Virtual Reality, Ankle Fracture, Balance Training, Berg Balance Scale, Star Excursion Balance Test, Range of Motion, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dr Aneeqa SultanUniversity, hospital or other
- Collaborators
- Mayo Hospital Lahore
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a parallel-group design in which participants were randomly assigned to one of two groups. Group A received virtual reality-based balance training, while Group B received conventional balance therapy. Both groups underwent supervised rehabilitation sessions for 6 to 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| VR-Based Balance Training | Experimental | Behavioral: Virtual Reality Balance System (VR-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. |
| Conventional Balance Therapy | Active comparator | Behavioral: Standard Physical Therapy (Conventional Exercise)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 informed consent and comply with the study protocol.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual 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. | Behavioural | VR-Based Balance Training |
| Standard 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. | Behavioural | Conventional Balance Therapy |
Primary outcome
Change in Static Balance Measured by the Berg Balance Scale (BBS)
Time frame: Baseline and immediately after the 6-to-8-week intervention
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.
Change in Dynamic Postural Control Measured by the Star Excursion Balance Test (SEBT)
Time frame: Baseline and immediately after the 6-to-8-week intervention
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.
1 secondary outcome
Change in Active Ankle Dorsiflexion Range of Motion
Time frame: Baseline and immediately after the 6-to-8-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Balance System (VR-Training) and Standard Physical Therapy (Conventional Exercise) in people with Ankle Fractures and Joint Stiffness, run by Dr Aneeqa Sultan at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Static Balance Measured by the Berg Balance Scale (BBS) (time frame: Baseline and immediately after the 6-to-8-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.