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Effect on Dynamic Postural Stability After Application of Cryotherapy to the Knee Joint

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03151031
Recruitment Status : Completed
First Posted : May 12, 2017
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)

Study Description
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Brief 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. 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

Condition or disease Intervention/treatment Phase
Cryotherapy Effect Balance; Disorder, Fluid Procedure: Cryotherapy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participants will not be informed about the reason for performing the star excursion balance test before and after the application of cryotherapy
Primary Purpose: Treatment
Official Title: Effect on Dynamic Postural Stability After Application of Cryotherapy to the Knee Joint: A Pilot Randomized Controlled Trial
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : September 11, 2017
Actual Study Completion Date : September 11, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Group
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
 Procedure: Cryotherapy
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.
No Intervention: Control Group
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


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Star Excursion Balance test at 10 minutes [ Time Frame: Upto 10 minutes ]
    Distance reach in 8 directions will be measured


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal adult person.
  • Aged between 18 to 30 year
  • Both male and female were included in the study

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151031


Locations
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India
Asir John Samuel
Ambala, Haryana, India, 133207
Sponsors and Collaborators
Asir John Samuel
Investigators
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Study Director: Asir J Samuel, MPT Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
More Information
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Additional Information:

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Responsible Party: Asir John Samuel, Assistant Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markendeswar University (Deemed to be University)
ClinicalTrials.gov Identifier: NCT03151031    
Other Study ID Numbers: MMIPR/SPCA/17/14
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Through ms excel file in data repository of university
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 1
Access Criteria: https://www.termedia.pl/Effect-on-dynamic-postural-stability-after-application-of-cold-therapy-to-the-knee-joint-A-pilot-randomized-controlled-trial,128,43981,0,1.html
URL: https://www.termedia.pl/Effect-on-dynamic-postural-stability-after-application-of-cold-therapy-to-the-knee-joint-A-pilot-randomized-controlled-trial,128,43981,0,1.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asir John Samuel, Maharishi Markendeswar University (Deemed to be University):
balance
college students
star excursion balance test