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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

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE December 27, 2018
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE January 5, 2019
Actual Primary Completion Date April 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Localized Muscle Cooling on Balance in Healthy Individuals
Official Title  ICMJE Effect of Localized Muscle Cooling on Balance in Healthy Individuals
Brief Summary This study aims to investigate the effects of localized muscle cooling on static and dynamic stability in healthy adults.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Quadriceps cooling
    Participants in this group will receive a cold pack on anterior thigh muscles for 20 minutes.
    Intervention: Behavioral: cooling
  • Experimental: Hamstring cooling
    Participants in this group will receive a cold pack on posterior thigh muscles for 20 minutes.
    Intervention: Behavioral: cooling
  • Experimental: Calf cooling
    Participants in this group will receive a cold pack on posterior leg muscles for 20 minutes.
    Intervention: Behavioral: cooling
  • Experimental: Back cooling
    Participants in this group will receive a cold pack on posterior low back muscles for 20 minutes.
    Intervention: Behavioral: cooling
  • No Intervention: Control
    The participants in the control group will be rested for 20 minutes without any intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 15, 2019
Actual Primary Completion Date April 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03788135
Other Study ID Numbers  ICMJE RRC-2018-011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Shahnawaz Anwer, King Saud University
Study Sponsor  ICMJE King Saud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: AHMAD H ALGHADIR, PHD King Saud University
PRS Account King Saud University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP