NCT03788135

Brief Summary

This study aims to investigate the effects of localized muscle cooling on static and dynamic stability in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable healthy

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

First Submitted

Initial submission to the registry

December 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

January 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

December 20, 2018

Last Update Submit

August 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • mean center of gravity (COG) sway velocity (degrees/sec) for the unilateral Stance (US)

    The participants will be asked to stood in the marked position on the force plate, with their hands positioned on the iliac crests. The participants will be requested to lift the right foot to a standard height of 10 cm. This 10-second test will be performed three times in two test conditions, including eyes open (EO) and eyes closed (EC). The mean COG sway velocity (degrees/sec) from three trials of the US will be used in the analysis. The participants will be requested to perform the same test for the left leg. The US will be used to determine each participant's ability to maintain postural stability during unilateral standing in the EO and EC conditions.

    up to 3 weeks

Study Arms (5)

Quadriceps cooling

EXPERIMENTAL

Participants in this group will receive a cold pack on anterior thigh muscles for 20 minutes.

Behavioral: cooling

Hamstring cooling

EXPERIMENTAL

Participants in this group will receive a cold pack on posterior thigh muscles for 20 minutes.

Behavioral: cooling

Calf cooling

EXPERIMENTAL

Participants in this group will receive a cold pack on posterior leg muscles for 20 minutes.

Behavioral: cooling

Back cooling

EXPERIMENTAL

Participants in this group will receive a cold pack on posterior low back muscles for 20 minutes.

Behavioral: cooling

Control

NO INTERVENTION

The participants in the control group will be rested for 20 minutes without any intervention.

Interventions

coolingBEHAVIORAL

the participants in the experimental group will receive a cold pack (gel pack, temperature -6 degrees to -12 degrees Celsius) will be placed on the target muscles for 20 minutes.

Back coolingCalf coolingHamstring coolingQuadriceps cooling

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young adults

You may not qualify if:

  • history of a hip or knee injury, sensory deficits in the lower extremity and lower back, a history of lower-extremity surgery, spinal surgery, or a history of a quadriceps or hamstring muscle injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RRC, KSU

Riyadh, Saudi Arabia

Location

MeSH Terms

Interventions

Cool-Down Exercise

Intervention Hierarchy (Ancestors)

Post-Exercise Recovery TechniquesPhysical Therapy ModalitiesTherapeuticsRehabilitationExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • AHMAD H ALGHADIR, PHD

    King Saud University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 27, 2018

Study Start

January 5, 2019

Primary Completion

April 25, 2019

Study Completion

May 15, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Data will be kept secure with the principal investigator (MR. SHAHNAWAZ ANWER) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues

Locations