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

August 22, 2021 updated by: Asir John Samuel

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Ambala, Haryana, India, 133207
        • Asir John Samuel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Star Excursion Balance test at 10 minutes
Time Frame: Upto 10 minutes
Distance reach in 8 directions will be measured
Upto 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asir John Samuel

Investigators

  • Study Director: Asir J Samuel, MPT, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2017

Primary Completion (ACTUAL)

September 11, 2017

Study Completion (ACTUAL)

September 11, 2017

Study Registration Dates

First Submitted

May 7, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (ACTUAL)

May 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 22, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MMIPR/SPCA/17/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Through ms excel file in data repository of university

IPD Sharing Time Frame

1

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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