Return to Physical Activity Following Injury: Towards Understanding a More Accessible Solution for Shorter Recovery Time.

NCT ID: NCT03899714

Last Updated: 2019-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2019-06-01

Brief Summary

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The purpose of this study is to investigate the effect of cryotherapy application on hip adductors and ankle evertors on the Overall Stability Index (OSI), the Medio-Lateral Stability Index (MLSI), and the Antero-Posterior Stability Index (APSI) in healthy adult females.

Detailed Description

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Cryotherapy is one of the most common and inexpensive forms of treatment for both acute and chronic injuries. Yet, there is a deficiency in research concerning the impact of cooling on balance in healthy females

Conditions

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Cryotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be randomly assigned into one of two locations of the cryotherapy application. Some began the session with cryotherapy being applied on their ankle evertors, while others began the session with the cryotherapy being applied on their hip adductors.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ankle evertors

Ice packs will be applied to the selected muscles according to the random selection that will be performed previously. The ice bags will be filled with crushed ice, weighing approximately one half of a kilogram. They will be wrapped in a thin cotton towel, and applied on the skin along the anatomical location of the tested muscles. For the ankle evertors, the ice bag will be applied to the lateral side of the ankle encompassing the lateral malleolus.The cryotherapy session will be lasted for exactly 20 minutes . Sessions will be separated by a 30-minute rest interval

Group Type ACTIVE_COMPARATOR

Cryotherapy

Intervention Type OTHER

Crushed ice in a plastic bag will be used, as it is a widely accessible and financially convenient method of cryotherapy. One half of a kilogram of ice will be placed in a plastic bag. The plastic bags will be 17 cm wide and 22 cm long. The air will be squeezed out of the bag and it will be sealed. The bag will be wrapped in a wet towel and applied to the tested area. Every five bags of crushed ice will be kept in an insulated foam container containing one kilogram of dry ice. Dry ice has a temperature of negative 80 degrees Celsius, and is used to keep the bags of crushed ice in a frozen state till the participants are briefed and the testing began.

Hip adductors

Ice packs will be applied to the selected muscles according to the random selection that will be performed previously. The ice bags will be filled with crushed ice, weighing approximately one half of a kilogram. They will be wrapped in a thin cotton towel, and applied on the skin along the anatomical location of the tested muscles. For the hip adductors, the ice bag will be applied to the medial side of the thigh, covering the entire area from the groin, to just above the knee joint. The cryotherapy session will be lasted for exactly 20 minutes . Sessions will be separated by a 30-minute rest interval

Group Type ACTIVE_COMPARATOR

Cryotherapy

Intervention Type OTHER

Crushed ice in a plastic bag will be used, as it is a widely accessible and financially convenient method of cryotherapy. One half of a kilogram of ice will be placed in a plastic bag. The plastic bags will be 17 cm wide and 22 cm long. The air will be squeezed out of the bag and it will be sealed. The bag will be wrapped in a wet towel and applied to the tested area. Every five bags of crushed ice will be kept in an insulated foam container containing one kilogram of dry ice. Dry ice has a temperature of negative 80 degrees Celsius, and is used to keep the bags of crushed ice in a frozen state till the participants are briefed and the testing began.

Interventions

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Cryotherapy

Crushed ice in a plastic bag will be used, as it is a widely accessible and financially convenient method of cryotherapy. One half of a kilogram of ice will be placed in a plastic bag. The plastic bags will be 17 cm wide and 22 cm long. The air will be squeezed out of the bag and it will be sealed. The bag will be wrapped in a wet towel and applied to the tested area. Every five bags of crushed ice will be kept in an insulated foam container containing one kilogram of dry ice. Dry ice has a temperature of negative 80 degrees Celsius, and is used to keep the bags of crushed ice in a frozen state till the participants are briefed and the testing began.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy females will participate in this study. All participants should have unrestricted ankle and hip joints range of motion as well as ankle and hip muscles strength grade four to five (using manual muscle testing).

Exclusion Criteria

* Participants will be excluded from the study if they had any previous history of hip or ankle joint neuromuscular or musculoskeletal injury or surgery, any pathology to the hip or ankle joints (i.e. abnormal ligament laxity and congenital deformities), any problems related to balance and stability.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Abeer Farag Hanafy

Lecturer of Biomechanics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman G Matar, PhD

Role: STUDY_DIRECTOR

Lecturer of Biomechanics

Nagui S Nassif, Prof.

Role: STUDY_CHAIR

Assistant Professor of Biomechanics

Naglaa M Elhafez, Prof.

Role: STUDY_CHAIR

Professor of Biomechanics

Ghada M Elhafez, Prof.

Role: STUDY_DIRECTOR

Professor of Biomechanics

Sondus Hassounah, Public Health Teaching Fellow

Role: STUDY_CHAIR

Public Health Teaching Fellow

Central Contacts

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Abeer F Hanafy, PhD

Role: CONTACT

01063044443

Samar O Hassounah, Master

Role: CONTACT

0237617691

References

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Algafly AA, George KP. The effect of cryotherapy on nerve conduction velocity, pain threshold and pain tolerance. Br J Sports Med. 2007 Jun;41(6):365-9; discussion 369. doi: 10.1136/bjsm.2006.031237. Epub 2007 Jan 15.

Reference Type BACKGROUND
PMID: 17224445 (View on PubMed)

Bleakley C, McDonough S, MacAuley D. The use of ice in the treatment of acute soft-tissue injury: a systematic review of randomized controlled trials. Am J Sports Med. 2004 Jan-Feb;32(1):251-61. doi: 10.1177/0363546503260757.

Reference Type BACKGROUND
PMID: 14754753 (View on PubMed)

Other Identifiers

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Cryotherapy and Balance

Identifier Type: -

Identifier Source: org_study_id

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