NCT04487821

Brief Summary

Traumatic brain injury (TBI) is one and utmost rampant attained neurological conditions which can happen in young adults. Vestibular Rehabilitation Therapy can help them improve their balance, speed and agility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

January 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

July 23, 2020

Last Update Submit

July 23, 2020

Conditions

Keywords

Traumatic Brain InjuryConcussionVestibular Rehabilitation TherapyFootballBalance

Outcome Measures

Primary Outcomes (3)

  • Balance

    Balance Error Scoring System (BESS) which us used to evaluate the balance of the athlete

    upto 8 weeks

  • Agility

    30 Ft Agility Shuttle Run which is used to evaluate agility of athletes

    upto 8 weeks

  • Speed

    30 Meter dash which is used to evaluate the speed of the athlete

    upto 8 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Subjects were randomly assigned and informed consent was obtained, the subjects were educated about treatment. This contained 4 types of progressive activities. Respectively every type contains 2 to 4 tasks, performed in sets of 10 repetitions for 4 weeks. Results were obtained by using Balance scoring system, and physical performance test for speed and agility

Other: Cawthorne Cooksey Exercises

Control Group

NO INTERVENTION

Control group: (Group B) Subjects were randomly assigned and informed consent was obtained, the subjects were educated about treatment. They were asked to perform the regular drills. Results were obtained using Balance Error scoring system and physical performance test for speed and agility.

Interventions

Activity sitting on the "Exercise Ball" swing (eye movements, first slow and then fast) Swing sitting activity (head movements, first slow then fast - eyes open and eyes closed) Trunk activities focusing on balance Dynamic balance activity focusing on standing

Experimental Group

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Active Male football player. Age between 15-25 years. Known cases of concussion were included in the study. Those patients complaining mild vertigo \& participating in sports

You may not qualify if:

  • Concussion other than sports. History of metabolic diseases. History of recent fractures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syed Alamdar Hussain

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Brain ConcussionBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Syed Alamdar Hussain

Study Record Dates

First Submitted

July 23, 2020

First Posted

July 27, 2020

Study Start

January 1, 2020

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations