Effect of thigh muscle cooling on standing balance in healthy young males
ISRCTN | ISRCTN11597744 |
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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
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
Scientific
King Saud University
Building Number 24
College of Applied Medical Sciences
G095/1
Rehabilitation Research Chair
Riyadh
11433
Saudi Arabia
0000-0003-3187-8062 |
Study information
Study design | Randomised controlled trial |
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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 |
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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
Building Number 24 G095/1
Riyadh
11433
Saudi Arabia
Sponsor information
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/ |
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https://ror.org/02f81g417 |
Funders
Funder type
University/education
No information available
Results and Publications
Intention to publish date | 01/07/2017 |
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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? |
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Results article | results | 01/09/2017 | Yes | No |
Editorial Notes
15/01/2018: Publication reference added.