Localized Muscle Cooling on Balance in Healthy Individuals

Healthy Clinical Trial

Official title:

Effect of Localized Muscle Cooling on Balance in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788135
• Other study ID #: RRC-2018-011
• Status: Completed
• Phase: N/A
• Start date: January 5, 2019
• Est. completion date: May 15, 2019

Study information

• Verified date: August 2019
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 15, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	RRC, KSU	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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