NCT07729761

Brief Summary

We are conducting RCT study on concussion on combat sports athlete and there is high incidence of on concussion in this sports and we will find the association between concussion and vestibular impairment and then we will apply intervention (instabiliy training) to find the results

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2024

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

March 17, 2024

Last Update Submit

July 27, 2026

Conditions

Keywords

Vestibular impairmentinstability trainingCombat athleteConcussion

Outcome Measures

Primary Outcomes (1)

  • Sports Concussion Office Assessment Tool

    14 item scale use for diagnose , evaluate and for treatment purposes The SCOAT6 score is derived from the athlete's performance across these domains. Each component has specific criteria for correct responses or performance, and the total score reflects the overall level of impairment: Higher scores generally indicate better cognitive and physical function and fewer symptoms. Lower scores suggest more severe concussion effects or slower recovery.

    4th week

Secondary Outcomes (1)

  • CANTU

    1st week

Study Arms (2)

Traditional Physical therapy

ACTIVE COMPARATOR

Cone exercise. b) Advanced cone exercise. c) Circle of cones. d) Cut-backs. e) Shooting from a square pass. f) One-touch shooting. g) Three goal drill. h) Lay-offs, turns, and chest control. 4 units weekly for 4 weeks

Other: Traditional Physical therapy

Instability training

EXPERIMENTAL

Four units weekly, Time of the one exercise 30seconds with resting interval of 30 seconds between two exercises i.e. the whole unit takes 270 seconds and takes rest 135 seconds between exercises groups, Balance on the ball for 1-2 minutes,) Ground Control Drills 3 rounds of 2-3 minutes each. Sports specific instability training: Shadowboxing

Other: Instability training

Interventions

Cone exercise. b) Advanced cone exercise. c) Circle of cones. d) Cut-backs. e) Shooting from a square pass. f) One-touch shooting. g) Three goal drill. h) Lay-offs, turns, and chest control. 4 units weekly for 4 weeks

Traditional Physical therapy

four units weekly, Time of the one exercise 30seconds with resting interval of 30 seconds between two exercises i.e. the whole unit takes 270 seconds and takes rest 135 seconds between exercises groups, Balance on the ball for 1-2 minutes,) Ground Control Drills 3 rounds of 2-3 minutes each. Sports specific instability training: Shadowboxing

Instability training

Eligibility Criteria

Age18 Years - 36 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThere was less population of females in combat sports in my area
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Active Male Combat sports player.
  • Age between 18-25 years.
  • Athletes who had a hit on jaw, neck, head and had symptom of concussion discussed under heading of Introduction.
  • Athlete who had history of concussion between 3-30 days.
  • Mild concussion according to CANTU

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)

KAK'S Fight club

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (10)

  • Powell JW. Cerebral Concussion: Causes, Effects, and Risks in Sports. J Athl Train. 2001 Sep;36(3):307-311.

    PMID: 12937501BACKGROUND
  • Meaney DF, Smith DH. Biomechanics of concussion. Clin Sports Med. 2011 Jan;30(1):19-31, vii. doi: 10.1016/j.csm.2010.08.009.

    PMID: 21074079BACKGROUND
  • Pertab JL, Merkley TL, Cramond AJ, Cramond K, Paxton H, Wu T. Concussion and the autonomic nervous system: An introduction to the field and the results of a systematic review. NeuroRehabilitation. 2018;42(4):397-427. doi: 10.3233/NRE-172298.

    PMID: 29660949BACKGROUND
  • Christy JB, Cochrane GD, Almutairi A, Busettini C, Swanson MW, Weise KK. Peripheral Vestibular and Balance Function in Athletes With and Without Concussion. J Neurol Phys Ther. 2019 Jul;43(3):153-159. doi: 10.1097/NPT.0000000000000280.

    PMID: 31205229BACKGROUND
  • Schneider KJ, Leddy JJ, Guskiewicz KM, Seifert T, McCrea M, Silverberg ND, Feddermann-Demont N, Iverson GL, Hayden A, Makdissi M. Rest and treatment/rehabilitation following sport-related concussion: a systematic review. Br J Sports Med. 2017 Jun;51(12):930-934. doi: 10.1136/bjsports-2016-097475. Epub 2017 Mar 24.

    PMID: 28341726BACKGROUND
  • Sekendiz B, Cug M, Korkusuz F. Effects of Swiss-ball core strength training on strength, endurance, flexibility, and balance in sedentary women. J Strength Cond Res. 2010 Nov;24(11):3032-40. doi: 10.1519/JSC.0b013e3181d82e70.

    PMID: 20940644BACKGROUND
  • Norozi Z, Eskandari Z, Miri HJIJoSE, Research H. The effect of swiss ball training on core stability and balance functions in students with congenital deafness. 2021;5(1):6-9.

    BACKGROUND
  • Patricios JS, Davis GA, Ahmed OH, Blauwet C, Schneider GM, Purcell LK, Echemendia RJ, Fremont P, Fuller GW, Herring SA, Harmon KG, Loosemore M, Makdissi M, O'Halloran P, Putukian M, Turner M, Webborn N, Yeates KO, van Ierssel J, Schneider KJ. Introducing the Sport Concussion Office Assessment Tool 6 (SCOAT6). Br J Sports Med. 2023 Jun;57(11):648-650. doi: 10.1136/bjsports-2023-106860. No abstract available.

    PMID: 37316211BACKGROUND
  • Galetta KM, Barrett J, Allen M, Madda F, Delicata D, Tennant AT, Branas CC, Maguire MG, Messner LV, Devick S, Galetta SL, Balcer LJ. The King-Devick test as a determinant of head trauma and concussion in boxers and MMA fighters. Neurology. 2011 Apr 26;76(17):1456-62. doi: 10.1212/WNL.0b013e31821184c9. Epub 2011 Feb 2.

    PMID: 21288984BACKGROUND
  • Viano DC, Casson IR, Pellman EJ, Bir CA, Zhang L, Sherman DC, Boitano MA. Concussion in professional football: comparison with boxing head impacts--part 10. Neurosurgery. 2005 Dec;57(6):1154-72; discussion 1154-72. doi: 10.1227/01.neu.0000187541.87937.d9.

    PMID: 16331164BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

  • Osama Faisal, MS*SPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2024

First Posted

July 28, 2026

Study Start

October 23, 2023

Primary Completion

February 5, 2024

Study Completion

June 2, 2024

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations