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Localized Muscle Cooling on Balance in Healthy Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788135
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Shahnawaz Anwer, King Saud University

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

Condition or disease Intervention/treatment Phase
Healthy Behavioral: cooling Not Applicable

Detailed Description:
Healthy young adult aged 18-30 years will be recruited from the College of Applied Medical Sciences (CAMS), King Saud University, Riyadh. Subjects will be excluded if they had a history of a hip or knee injury, sensory deficits in the lower extremity, a history of lower-extremity surgery, or a history of a quadriceps or hamstring muscle injury. The protocol was submitted to and approved by the Ethics Sub-Committee of Rehabilitation Research chair (RRC-2018-011). Participants will be requested to sign a written informed consent form approved by the institution ethics committee. A total of 50 participants were randomly assigned to the quadriceps cooling (QC: n = 10), hamstrings cooling (HC: n = 10), calf cooling (CC: n = 10), back muscle cooling (BC: n = 10) or control (no cooling: n = 10) group by a lottery method.A baseline assessment of mean center of gravity (COG), sway velocity (degrees/sec) for the unilateral Stance (US) will be performed. After the baseline assessment, a cold pack (gel pack, temperature -6 degrees to -12 degrees Celsius) will be placed on the target muscle for 20 minutes. One thin dry towel will be kept between the cold pack and the skin to prevent skin damage. Before and after the application of ice application the skin sensibility will be assessed by testing the participant's to a pinprick.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Localized Muscle Cooling on Balance in Healthy Individuals
Actual Study Start Date : January 5, 2019
Actual Primary Completion Date : April 25, 2019
Actual Study Completion Date : May 15, 2019

Arm Intervention/treatment
Experimental: Quadriceps cooling
Participants in this group will receive a cold pack on anterior thigh muscles for 20 minutes.
Behavioral: cooling
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.

Experimental: Hamstring cooling
Participants in this group will receive a cold pack on posterior thigh muscles for 20 minutes.
Behavioral: cooling
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.

Experimental: Calf cooling
Participants in this group will receive a cold pack on posterior leg muscles for 20 minutes.
Behavioral: cooling
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.

Experimental: Back cooling
Participants in this group will receive a cold pack on posterior low back muscles for 20 minutes.
Behavioral: cooling
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.

No Intervention: Control
The participants in the control group will be rested for 20 minutes without any intervention.



Primary Outcome Measures :
  1. mean center of gravity (COG) sway velocity (degrees/sec) for the unilateral Stance (US) [ Time Frame: up to 3 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy young adults

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788135


Locations
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Saudi Arabia
RRC, KSU
Riyadh, Saudi Arabia
Sponsors and Collaborators
King Saud University
Investigators
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Study Chair: AHMAD H ALGHADIR, PHD King Saud University

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Responsible Party: Shahnawaz Anwer, Principal Investigator, King Saud University
ClinicalTrials.gov Identifier: NCT03788135    
Other Study ID Numbers: RRC-2018-011
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be kept secure with the principal investigator (MR. SHAHNAWAZ ANWER) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No