Cryotherapy EffectNCT03151031
Effect on Dynamic Postural Stability After Application of Cryotherapy to the Knee Joint
A study testing Cryotherapy in people with Cryotherapy Effect and Balance; Disorder, Fluid, run by Asir John Samuel at 1 site in India.
Trial summary
The purpose of this study will determine the effect of cryotherapy applied to the knee joint on static and dynamic standing balance. It is hypothesized that there will be no change in dynamic postural stability after cryotherapy application.Twenty four individuals (age 18 to 30) participated in the study. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect, Balance; Disorder, Fluid
- What is being tested?
- Cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 15 May 2017to 11 Sep 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal adult person.
- Aged between 18 to 30 year
- Both male and female were included in the study
Who cannot join
- Adult having any visual impairment
- Adult having any vestibular impairment
- Adult suffering from any neurological disorders
- Adult suffering from other medical conditions, like- Vascular diseases
- Adult having any disorders or conditions like- Genu valgum, Genu varum, history of knee joint or lower limb injury, or lower limb fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect on Dynamic Postural Stability After Application of Cryotherapy to the Knee Joint: A Pilot Randomized Controlled Trial
The purpose of this study will determine the effect of cryotherapy applied to the knee joint on static and dynamic standing balance. It is hypothesized that there will be no change in dynamic postural stability after cryotherapy application.Twenty four individuals (age 18 to 30) participated in the study. They will be randomly divided into two groups, experimental and control group. Each participant, in the experimental group will be asked to perform star excursion balance test (SEBT) under two conditions, before and after the application of cryotherapy. The participants will receive ice pack wrapping of the knee for 10 minutes. The control group performed SEBT at room temperature in an interval of 10 minutes. The two group will be analysed and compared
Read the detailed description
The cooling procedure for the knee joint was initiated by using a cryopack or cold-pack. On completion of the initial SEBT, the participant lied supine and the investigator applied the cryotherapy for 10 minutes. After the 10 minute period of cryotherapy, the cryopack was removed, and the participants performed SEBT for the second time.
- Conditions
- Cryotherapy Effect, Balance; Disorder, Fluid
- Being tested
- Cryotherapy
- Keywords
- balance, college students, star excursion balance test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
The cooling procedure for the knee joint will be initiated by using a cryopack or cold-pack. On completion of the initial SEBT, the participant will lie supine and the investigator will apply the cryotherapy for 10 minutes. After the 10 minute period of cryotherapy, the cryopack will be removed, and the participants will perform SEBT for the second time.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | In the experimental group, the participants will be asked to perform star excursion balance test (SEBT) under two conditions, before and after the application of cryotherapy Receives: Procedure: Cryotherapy |
| Control Group | No intervention | In the control group, the participants will be asked asked to perform star excursion balance test (SEBT) under two conditions, before and after 10 minutes rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Star Excursion Balance test at 10 minutes
Distance reach in 8 directions will be measured
Measured: Upto 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start15 May 2017
- Primary completion11 Sep 2017
- Study completion11 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryotherapy EffectStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Asir J Samuel, MPT, Study director, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151031
- Sponsor's protocol ID
- MMIPR/SPCA/17/14
- Status last verified
- Aug 2021
- First submitted
- 7 May 2017
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Through ms excel file in data repository of university
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Dynamic Postural Stability After Application of Cryotherapy to the Knee Joint: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03151031
- Acronym / sponsor ID
- MMIPR/SPCA/17/14
- Conditions
- Cryotherapy Effect, Balance; Disorder, Fluid
- Keywords
- balance, college students, star excursion balance test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 11 Sep 2017 (actual)
- First posted
- 12 May 2017 (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.
The purpose of this study will determine the effect of cryotherapy applied to the knee joint on static and dynamic standing balance. It is hypothesized that there will be no change in dynamic postural stability after cryotherapy application.Twenty four individuals (age 18 to 30) participated in the study. They will be randomly divided into two groups, experimental and control group. Each participant, in the experimental group will be asked to perform star excursion balance test (SEBT) under two conditions, before and after the application of cryotherapy. The participants will receive ice pack wrapping of the knee for 10 minutes. The control group performed SEBT at room temperature in an interval of 10 minutes. The two group will be analysed and compared
Detailed description
The cooling procedure for the knee joint was initiated by using a cryopack or cold-pack. On completion of the initial SEBT, the participant lied supine and the investigator applied the cryotherapy for 10 minutes. After the 10 minute period of cryotherapy, the cryopack was removed, and the participants performed SEBT for the second time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: CryotherapyIn the experimental group, the participants will be asked to perform star excursion balance test (SEBT) under two conditions, before and after the application of cryotherapy |
| Control Group | No intervention | –In the control group, the participants will be asked asked to perform star excursion balance test (SEBT) under two conditions, before and after 10 minutes rest |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal adult person.
- Aged between 18 to 30 year
- Both male and female were included in the study
Key exclusion criteria (5 listed)
- Adult having any visual impairment
- Adult having any vestibular impairment
- Adult suffering from any neurological disorders
- Adult suffering from other medical conditions, like- Vascular diseases
- Adult having any disorders or conditions like- Genu valgum, Genu varum, history of knee joint or lower limb injury, or lower limb fracture
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 |
|---|---|---|
| CryotherapyThe cooling procedure for the knee joint will be initiated by using a cryopack or cold-pack. On completion of the initial SEBT, the participant will lie supine and the investigator will apply the cryotherapy for 10 minutes. After the 10 minute period of cryotherapy, the cryopack will be removed, and the participants will perform SEBT for the second time. | Procedure or surgery | Experimental Group |
Primary outcome
Change from Baseline Star Excursion Balance test at 10 minutes
Time frame: Upto 10 minutes
Distance reach in 8 directions will be measured
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 26 Aug 2021.
- Published ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Through ms excel file in data repository of university
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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.
Asir J Samuel, MPT study director
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Cryotherapy Effect and Balance; Disorder, Fluid, run by Asir John Samuel at 1 site in India.
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 3 inclusion and 5 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 26 Aug 2021. 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 India. 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?
Change from Baseline Star Excursion Balance test at 10 minutes (time frame: Upto 10 minutes). 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 26 Aug 2021.