Back to resultsEfficacy of Balance Training by BBS on Gait Parameters and Balance in Patients With RLAS
Primary Purpose
Ankle Sprains
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Biodex Balance System
specific physical therapy exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Sprains
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.
Sites / Locations
- Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Experimental Group
Controlled Group
Arm Description
Group (A) twenty-five patients will receive biodex balance training
twenty-five patients will receive a physical therapy exercise protocol
Outcomes
Primary Outcome Measures
Cadence
Change in Cadence measurements using Walkway Gait System.
Gait time
Change in Gait time measurements using Walkway Gait System.
Clinical Test of Sensory Integration
Change in Clinical Sensory Integration test measurements using Biodex balance System.
Secondary Outcome Measures
Full Information
NCT ID
NCT04773990
First Posted
February 11, 2021
Last Updated
June 27, 2021
Sponsor
MTI University
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT04773990
Brief Title
Efficacy of Balance Training by BBS on Gait Parameters and Balance in Patients With RLAS
Official Title
Efficacy of Balance Training by Biodex Balance System on Gait Parameters and Balance in Patients With RLAS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MTI University
Collaborators
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Other
Arm Description
Group (A) twenty-five patients will receive biodex balance training
Arm Title
Controlled Group
Arm Type
Other
Arm Description
twenty-five patients will receive a physical therapy exercise protocol
Intervention Type
Device
Intervention Name(s)
Biodex Balance System
Other Intervention Name(s)
BBS
Intervention Description
Subjects will receive several unique training modules using biodex
Intervention Type
Other
Intervention Name(s)
specific physical therapy exercise program
Intervention Description
Subjects will receive recommended PT program
Primary Outcome Measure Information:
Title
Cadence
Description
Change in Cadence measurements using Walkway Gait System.
Time Frame
Before Treatment and after 6 weeks of treatment
Title
Gait time
Description
Change in Gait time measurements using Walkway Gait System.
Time Frame
Before Treatment and after 6 weeks of treatment
Title
Clinical Test of Sensory Integration
Description
Change in Clinical Sensory Integration test measurements using Biodex balance System.
Time Frame
Before Treatment and after 6 weeks of treatment
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
25 male , 25 female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
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.
Facility Information:
Facility Name
Physical Therapy
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Balance Training by BBS on Gait Parameters and Balance in Patients With RLAS
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