Effect of thigh muscle cooling on standing balance in healthy young males

ISRCTN	ISRCTN11597744
DOI	https://doi.org/10.1186/ISRCTN11597744
Secondary identifying numbers	N/A

Submission date: 25/12/2016
Registration date: 06/01/2017
Last edited: 15/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims:
The use of cryotherapy (cooling therapy) in the form of ice packs, gel packs, and ice immersion are frequently used to treat minor muscle injuries. Although ice is known to be effective in decreasing pain and feeling, its effect on balance has received comparatively little attention. In addition to the various benefits of cryotherapy, reduced performance scores have been reported immediately after treatment. The role of quadriceps (thigh) and hamstring (calf) muscles for maintaining standing balance is well established, but the effect of cooling of these muscles on standing balance has not been reported previously. The aim of this study therefore is to compare the effect cooling the quadriceps and hamstring muscles on standing balance in healthy men.

Who can participate?
Healthy men aged between 20 and 30.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group are asked to lie down on their back and have a cool pack placed on their thigh for 20 minutes. Those in the second group are asked to lie down on their front and have a cool pack placed on their calf for 20 minutes. Those in the third group rest for 20 minutes and do not receive any cooling. At the start of the study and after the cooling period (20 minutes), participants in all groups stand on a special plate which measures their balance.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.

Where is the study run from?
Rehabilitation Research Chair, King Saud University (Saudi Arabia)

When is the study starting and how long is it expected to run for?
December 2014 to March 2016

Who is funding the study?
Rehabilitation Research Chair, King Saud University (Saudi Arabia)

Who is the main contact?
Mr Shahnawaz Anwer

Contact information

Mr Shahnawaz Anwer
Scientific

King Saud University
Building Number 24
College of Applied Medical Sciences
G095/1
Rehabilitation Research Chair
Riyadh
11433
Saudi Arabia

ORCID ID	0000-0003-3187-8062

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of quadriceps and hamstrings muscle cooling on standing balance in healthy young males
Study objectives	1. The effects of quadriceps or hamstring muscles cooling on standing balance are significant in healthy individuals 2. The differences in the effects of quadriceps and hamstring muscles cooling on standing balance are significant in healthy individuals
Ethics approval(s)	CAMS Research ethics committee, King Saud University, Saudi Arabia, 08/01/2015, ref: CAMS 21/3536
Health condition(s) or problem(s) studied	Balance following muscle cooling
Intervention	Participants are randomised to one of three groups by lottery method. Quadriceps cooling (QC) group: Participants are asked to lie down in a supine position and a cold pack (gel pack, temperature -60 C to -120 C) is placed on the anterior thigh (from apex of patella to mid-thigh) of the both limbs for 20 minutes. Hamstrings cooling (HC) group: Participants are asked to lie down in a prone position and a cold pack (gel pack, temperature -60 C to -120 C) is placed on the posterior thigh (from base of the popliteal fossa to mid-thigh) of the both limbs for 20 minutes. Control (no cooling) group: Participants rest without any intervention. At baseline and post-cooling/rest (20 minutes) participants have their sway velocity assessed using a force plate.
Intervention type	Device
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	Sway velocity (degree/sec) for the Unilateral Stance (US) is tested on a force plate (NeuroCom Balance Master®) at baseline and immediately after the cooling protocol.
Secondary outcome measures	No secondary outcome measures
Overall study start date	12/12/2014
Completion date	01/03/2016

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Male
Target number of participants	30
Key inclusion criteria	1. Male 2. Age 20-30 years 3. Healthy
Key exclusion criteria	1. History of recent previous knee injury 2. Sensory deficits in lower extremity 3. History of previous recent lower extremity surgery
Date of first enrolment	10/02/2015
Date of final enrolment	20/12/2015

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

Rehabilitation Research Chair

College of Applied Medical Sciences, King Saud University
Building Number 24 G095/1
Riyadh
11433
Saudi Arabia

Sponsor information

King Saud University
University/education

Building Number 24
College of Applied Medical Sciences
G095/1
Rehabilitation Research Chair
Riyadh
11433
Saudi Arabia

Website	http://ksu.edu.sa/en/
"ROR"	https://ror.org/02f81g417

Funders

Funder type

University/education

Rehabilitation Research Chair, King Saud University

No information available

Results and Publications

Intention to publish date	01/07/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Shahnawaz Anwer (sanwer@ksu.edu.sa)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2017		Yes	No

Editorial Notes

15/01/2018: Publication reference added.