NCT04773990

Brief Summary

This study will be conducted to find out the effect of adding balance training on gait parameters, balance, and Sensory Interaction

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

February 11, 2021

Last Update Submit

June 27, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Cadence

    Change in Cadence measurements using Walkway Gait System.

    Before Treatment and after 6 weeks of treatment

  • Gait time

    Change in Gait time measurements using Walkway Gait System.

    Before Treatment and after 6 weeks of treatment

  • Clinical Test of Sensory Integration

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

    Before Treatment and after 6 weeks of treatment

Study Arms (2)

Experimental Group

OTHER

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

Device: Biodex Balance SystemOther: specific physical therapy exercise program

Controlled Group

OTHER

twenty-five patients will receive a physical therapy exercise protocol

Other: specific physical therapy exercise program

Interventions

Subjects will receive several unique training modules using biodex

Also known as: BBS
Experimental Group

Subjects will receive recommended PT program

Controlled GroupExperimental Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details25 male , 25 female
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy

Cairo, Egypt

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator at Department of musculoskeletal disorders and it's surgeries

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 26, 2021

Study Start

October 1, 2020

Primary Completion

January 31, 2021

Study Completion

February 15, 2021

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations