NCT03151031

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2017

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

May 7, 2017

Last Update Submit

August 22, 2021

Conditions

Keywords

balancecollege studentsstar excursion balance test

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Star Excursion Balance test at 10 minutes

    Distance reach in 8 directions will be measured

    Upto 10 minutes

Study Arms (2)

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

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

Interventions

CryotherapyPROCEDURE

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.

Experimental Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asir John Samuel

Ambāla, Haryana, 133207, India

Location

Related Links

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Asir J Samuel, MPT

    Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be informed about the reason for performing the star excursion balance test before and after the application of cryotherapy
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

May 7, 2017

First Posted

May 12, 2017

Study Start

May 15, 2017

Primary Completion

September 11, 2017

Study Completion

September 11, 2017

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

Through ms excel file in data repository of university

Shared Documents
STUDY PROTOCOL, 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
More information

Locations