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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03899714

Collaborator

(none)

Enrollment

Arms

1.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cryotherapy	Other: Cryotherapy	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 15, 2019

Anticipated Primary Completion Date :

May 15, 2019

Anticipated Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Other: 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.
Active Comparator: 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	Other: 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.

Arm

Intervention/Treatment

Active Comparator: 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

Other: 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.

Active Comparator: 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

Other: Cryotherapy

Outcome Measures

Primary Outcome Measures

Overall Stability Index [changes from Baseline to immediately after the cryotherapy application]
The Stability Index represented the variance of platform displacement in degrees from a leveled position in both the AP and ML directions. A high number is indicative of poor neuromuscular control, which may increase the potential for orthopedic injury or falling.

Secondary Outcome Measures

Medio-lateral Postural Stability Index [changes from Baseline to immediately after the cryotherapy application]
Antero-posterior Postural Stability index [changes from Baseline to immediately after the cryotherapy application]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

Study Director: Ayman G Matar, PhD, Lecturer of Biomechanics
Study Chair: Nagui S Nassif, Prof., Assistant Professor of Biomechanics
Study Chair: Naglaa M Elhafez, Prof., Professor of Biomechanics
Study Director: Ghada M Elhafez, Prof., Professor of Biomechanics
Study Chair: Sondus Hassounah, Public Health Teaching Fellow, Public Health Teaching Fellow

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Abeer Farag Hanafy, Lecturer of Biomechanics, Cairo University

ClinicalTrials.gov Identifier:

NCT03899714

Other Study ID Numbers:

Cryotherapy and Balance

First Posted:

Apr 2, 2019

Last Update Posted:

Apr 2, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Abeer Farag Hanafy, Lecturer of Biomechanics, Cairo University

Postural Stability

Public Health

Balance

Study Results

No Results Posted as of Apr 2, 2019