Ankle SprainsNCT04773990
Efficacy of Balance Training by BBS on Gait Parameters and Balance in Patients With RLAS
A study testing Biodex Balance System and specific physical therapy exercise program in people with Ankle Sprains, run by MTI University at 1 site in Egypt.
Trial summary
This study will be conducted to find out the effect of adding balance training on gait parameters, balance, and Sensory Interaction Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Biodex Balance System and specific physical therapy exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 15 Feb 2021
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient will be referred to the outpatient clinic of the orthopedic department, Faculty of physical therapy, MTI University. with a confirmed diagnosis of recurrent Lateral ankle sprain grade II
- Subjects will be excluded if they had one of the following criteria:
- Previous musculoskeletal injury to the lower limb or lumbar spine including a fracture, a sprain, or an unstable joint other than the injured ankle.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Balance Training by Biodex Balance System on Gait Parameters and Balance in Patients With RLAS
This study will be conducted to find out the effect of adding balance training on gait parameters, balance, and Sensory Interaction
Read the detailed description
LAS are not benign injuries. As many as 4 in 10 individuals will develop chronic ankle instability (CAI) after a first-time sprain, More than half of patients with osteoarthritis (OA) of the ankle report a history of a sport-related ankle injury, and 85% of those are LAS.
- Conditions
- Ankle Sprains
- Being tested
- Biodex Balance System, specific physical therapy exercise program
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodex Balance SystemDevice
Also called BBS
Subjects will receive several unique training modules using biodex
specific physical therapy exercise programOther
Subjects will receive recommended PT program
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Other | Group (A) twenty-five patients will receive biodex balance training Receives: Device: Biodex Balance System; Other: specific physical therapy exercise program |
| Controlled Group | Other | twenty-five patients will receive a physical therapy exercise protocol Receives: Other: specific physical therapy exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cadence
Change in Cadence measurements using Walkway Gait System.
Measured: Before Treatment and after 6 weeks of treatment
Gait time
Change in Gait time measurements using Walkway Gait System.
Measured: Before Treatment and after 6 weeks of treatment
Clinical Test of Sensory Integration
Change in Clinical Sensory Integration test measurements using Biodex balance System.
Measured: Before Treatment and after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Oct 2020
- Primary completion31 Jan 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies 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
- Factorial
- Model description
- Fifty subjects (power analysis) of both gender diagnosed with recurrent lateral ankle sprain patients will be assigned randomly into 2 groups. * Group (A) will receive biodex balance training * Group (B)will receive a physical therapy exercise protocol only
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Hadeer Gamal Abd-Elmaboud Maghraby, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773990
- Sponsor's protocol ID
- RLAS
- Status last verified
- Jun 2021
- First submitted
- 11 Feb 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- 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 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Balance Training by Biodex Balance System on Gait Parameters and Balance in Patients With RLAS
- ClinicalTrials.gov ID
- NCT04773990
- Acronym / sponsor ID
- RLAS
- Conditions
- Ankle Sprains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 26 Feb 2021 (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 will be conducted to find out the effect of adding balance training on gait parameters, balance, and Sensory Interaction
Detailed description
LAS are not benign injuries. As many as 4 in 10 individuals will develop chronic ankle instability (CAI) after a first-time sprain, More than half of patients with osteoarthritis (OA) of the ankle report a history of a sport-related ankle injury, and 85% of those are LAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Fifty subjects (power analysis) of both gender diagnosed with recurrent lateral ankle sprain patients will be assigned randomly into 2 groups. * Group (A) will receive biodex balance training * Group (B)will receive a physical therapy exercise protocol only
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Other | Device: Biodex Balance System, Other: specific physical therapy exercise programGroup (A) twenty-five patients will receive biodex balance training |
| Controlled Group | Other | Other: specific physical therapy exercise programtwenty-five patients will receive a physical therapy exercise protocol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The patient will be referred to the outpatient clinic of the orthopedic department, Faculty of physical therapy, MTI University. with a confirmed diagnosis of recurrent Lateral ankle sprain grade II
- Subjects will be excluded if they had one of the following criteria:
- Previous musculoskeletal injury to the lower limb or lumbar spine including a fracture, a sprain, or an unstable joint other than the injured ankle.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Biodex Balance SystemAlso: BBSSubjects will receive several unique training modules using biodex | Device | Experimental Group |
| specific physical therapy exercise programSubjects will receive recommended PT program | Other | Controlled Group, Experimental Group |
Primary outcome
Cadence
Time frame: Before Treatment and after 6 weeks of treatment
Change in Cadence measurements using Walkway Gait System.
Gait time
Time frame: Before Treatment and after 6 weeks of treatment
Change in Gait time measurements using Walkway Gait System.
Clinical Test of Sensory Integration
Time frame: Before Treatment and after 6 weeks of treatment
Change in Clinical Sensory Integration test measurements using Biodex balance System.
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 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Ankle Sprains
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Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
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Enovis High Ankle Sprain Brace Testing
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodex Balance System and specific physical therapy exercise program in people with Ankle Sprains, run by MTI University at 1 site in Egypt.
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 3 inclusion and 0 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 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Cadence (time frame: Before Treatment and after 6 weeks of treatment). The study lists 3 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 Jun 2021.