HealthyNCT03788135
Localized Muscle Cooling on Balance in Healthy Individuals
A study testing cooling in people with Healthy, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
This study aims to investigate the effects of localized muscle cooling on static and dynamic stability in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cooling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 5 Jan 2019to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Localized Muscle Cooling on Balance in Healthy Individuals
This study aims to investigate the effects of localized muscle cooling on static and dynamic stability in healthy adults.
Read the 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.
- Conditions
- Healthy
- Being tested
- cooling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coolingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Quadriceps cooling | Experimental | Participants in this group will receive a cold pack on anterior thigh muscles for 20 minutes. Receives: Behavioral: cooling |
| Hamstring cooling | Experimental | Participants in this group will receive a cold pack on posterior thigh muscles for 20 minutes. Receives: Behavioral: cooling |
| Calf cooling | Experimental | Participants in this group will receive a cold pack on posterior leg muscles for 20 minutes. Receives: Behavioral: cooling |
| Back cooling | Experimental | Participants in this group will receive a cold pack on posterior low back muscles for 20 minutes. Receives: Behavioral: cooling |
| Control | No intervention | The participants in the control group will be rested for 20 minutes without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start5 Jan 2019
- Primary completion25 Apr 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahnawaz Anwer, King Saud University
- Investigators
- AHMAD H ALGHADIR, PHD, Study chair, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788135
- Sponsor's protocol ID
- RRC-2018-011
- Status last verified
- Aug 2019
- First submitted
- 20 Dec 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be kept secure with the principal investigator (MR. SHAHNAWAZ ANWER) and sub-investigator (Dr. Ahmad Alghadir) due to confidentiality issues
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Localized Muscle Cooling on Balance in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03788135
- Acronym / sponsor ID
- RRC-2018-011
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Quadriceps cooling | Experimental | Behavioral: coolingParticipants in this group will receive a cold pack on anterior thigh muscles for 20 minutes. |
| Hamstring cooling | Experimental | Behavioral: coolingParticipants in this group will receive a cold pack on posterior thigh muscles for 20 minutes. |
| Calf cooling | Experimental | Behavioral: coolingParticipants in this group will receive a cold pack on posterior leg muscles for 20 minutes. |
| Back cooling | Experimental | Behavioral: coolingParticipants in this group will receive a cold pack on posterior low back muscles for 20 minutes. |
| Control | No intervention | –The participants in the control group will be rested for 20 minutes without any intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy young adults
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coolingthe 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. | Behavioural | Back cooling, Calf cooling, Hamstring cooling, Quadriceps cooling |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMAD H ALGHADIR, PHD study chair
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cooling in people with Healthy, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean center of gravity (COG) sway velocity (degrees/sec) for the unilateral Stance (US) (time frame: up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.