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CompletedNCT04773990Updated Jun 30, 2021

Efficacy of Balance Training by BBS on Gait Parameters and Balance in Patients With RLAS

An interventional study of Biodex Balance System and specific physical therapy exercise program in Ankle Sprains, sponsored by MTI University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-06-30.

Sponsored by MTI University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2020, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Ankle Sprains

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03

In context

Ankle Injuries

362 studies on the registry are indexed under Ankle Injuries; 72 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 281 interventional studies indexed under Ankle Injuries.

Browse Ankle Injuries studies →

Lead sponsor

MTI University is the lead sponsor of 61 studies on the registry; 11 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
50 participants (actual)

Study arms

  • Other
    Experimental Group

    Group (A) twenty-five patients will receive biodex balance training

    Device: Biodex Balance System · Other: specific physical therapy exercise program

  • Other
    Controlled Group

    twenty-five patients will receive a physical therapy exercise protocol

    Other: specific physical therapy exercise program

Interventions

  • DeviceBiodex Balance System

    Subjects will receive several unique training modules using biodex

    Also known as: BBS

  • Otherspecific physical therapy exercise program

    Subjects will receive recommended PT program

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What researchers measure

Primary outcomes

  1. Cadence

    Change in Cadence measurements using Walkway Gait System.

    Time frame: Before Treatment and after 6 weeks of treatment

  2. Gait time

    Change in Gait time measurements using Walkway Gait System.

    Time frame: Before Treatment and after 6 weeks of treatment

  3. Clinical Test of Sensory Integration

    Change in Clinical Sensory Integration test measurements using Biodex balance System.

    Time frame: Before Treatment and after 6 weeks of treatment

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Study locations

1 site
  • Physical Therapy
    Cairo, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04773990
Lead sponsor
MTI University
Collaborators
Cairo University
Responsible party
Hadeer Gamal Abd-Elmaboud Maghraby (Demonstrator at Department of musculoskeletal disorders and it's surgeries, MTI University) — Principal investigator
First posted
Feb 26, 2021
Start date
Oct 1, 2020
Primary completion
Jan 31, 2021
Completion
Feb 15, 2021
Last update
Jun 30, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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