Concussion, MildNCT04487821
EFFECTS OF VESTIBULAR REHABILITATION THERAPY (VRT) ON BALANCE, SPEED AND AGILITY IN POST-CONCUSSION FOOTBALL PLAYERS
A study testing Cawthorne Cooksey Exercises in people with Concussion, Mild, run by Zohra Institute of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men only
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Cawthorne Cooksey Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to 28 Feb 2020
- 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 25 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Concussion other than sports. History of metabolic diseases. History of recent fractures.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Total 40 sample size out of which were divided into control and experimental group. Concussed football athletes with age ranging 15-25 year, those participating actively in the sports were included in the study in the region of Kyber Pukhtoonkhwa Peshawar.
- Conditions
- Concussion, Mild
- Being tested
- Cawthorne Cooksey Exercises
- Keywords
- Traumatic Brain Injury, Concussion, Vestibular Rehabilitation Therapy, Football, Balance
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cawthorne Cooksey ExercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance Error Scoring System (BESS) which us used to evaluate the balance of the athlete
Measured: upto 8 weeks
Agility
30 Ft Agility Shuttle Run which is used to evaluate agility of athletes
Measured: upto 8 weeks
Speed
30 Meter dash which is used to evaluate the speed of the athlete
Measured: upto 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Jan 2020
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zohra Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Alamdar Hussain, Zohra Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487821
- Sponsor's protocol ID
- ZIHS-1205/MS/12
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF VESTIBULAR REHABILITATION THERAPY (VRT) ON BALANCE, SPEED AND AGILITY IN POST-CONCUSSION FOOTBALL PLAYERS
- ClinicalTrials.gov ID
- NCT04487821
- Acronym / sponsor ID
- ZIHS-1205/MS/12
- Conditions
- Concussion, Mild
- Keywords
- Traumatic Brain Injury, Concussion, Vestibular Rehabilitation Therapy, Football, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zohra Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 27 Jul 2020 (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.
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.
Detailed description
Total 40 sample size out of which were divided into control and experimental group. Concussed football athletes with age ranging 15-25 year, those participating actively in the sports were included in the study in the region of Kyber Pukhtoonkhwa Peshawar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Cawthorne Cooksey ExercisesSubjects 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 |
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Concussion other than sports. History of metabolic diseases. History of recent fractures.
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 |
|---|---|---|
| Cawthorne Cooksey ExercisesActivity 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 | Other | Experimental Group |
Primary outcome
Balance
Time frame: upto 8 weeks
Balance Error Scoring System (BESS) which us used to evaluate the balance of the athlete
Agility
Time frame: upto 8 weeks
30 Ft Agility Shuttle Run which is used to evaluate agility of athletes
Speed
Time frame: upto 8 weeks
30 Meter dash which is used to evaluate the speed of the athlete
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 27 Jul 2020.
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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 Cawthorne Cooksey Exercises in people with Concussion, Mild, run by Zohra Institute of Health Sciences at 1 site in Pakistan.
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 1 inclusion and 1 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 27 Jul 2020. 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 Pakistan. 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?
Balance (time frame: upto 8 weeks). 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 27 Jul 2020.