Wii Fit Exercises Versus Pilates Exercises in Adult Patients With Lower Extremity Burn

Burns Clinical Trial

Official title:

Wii Fit Exercises Versus Pilates Exercises on Muscle Strength, Postural Balance, and Functional Performance in Adult Patients With Lower Extremity Burn

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06081504
• Other study ID #: P.T.REC/012/004387
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: September 11, 2024

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: Shaimaa MA El Sayeh
• Phone: +201007766160
• Email: sh.sayeh87[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare the effect of Wii fit exercises and Pilates exercises on muscle strength and postural balance, and functional performance in adult patients with lower extremity burn.

Description:

Severe burn injuries are associated with hypermetabolic response and increased catabolism. These lead to a vast loss of muscle mass and reduced muscle strength. The main concern of burn injury rehabilitation has shifted from survival to optimizing functional outcomes and speeding up work return. Lower limbs (LL) are considered the most burned body parts, resulting in many potential complications, including pain, contractures, scars, altered sensations, muscle weakness, and postural balance impairment. Video game systems are more cost-effective than developing custom-designed rehabilitation equipment and are becoming increasingly popular among individuals undergoing physical rehabilitation. Among the most common video game systems used for this purpose (Wii Fit, Dance Revolution, EyeToy, and Kinect), Nintendo's Wii Fit is the most popular. It was the first video game system to use body movements as a game controller. The exerciser stands on an external balance board and controls the movement of a virtual character in the game by changing the center of pressure on the board. The game provides both visual and auditory feedback to the exerciser. This system combines fun with physical exercise for all ages as it allows for work on joint flexibility, muscular strength, and postural ergonomics. Pilates is a mind/body exercise that requires core stability, strength, flexibility, and attention to muscle control, posture, and breathing. Pilates exercise is performed solo in one's own space, so there is no risk of collision or other contact with others. The risk of injury to the musculoskeletal system is therefore minimized, making Pilates a relatively safe form of exercise. To the authors' knowledge there are no previous studies comparing the effect of Wii fit exercises and Pilates exercises on muscle strength and postural balance, functional performance in adult patients with lower extremity burn so, this study is designed to compare the effect of Wii fit exercises and Pilates exercises on muscle strength and postural balance, functional performance in adult patients with lower extremity burn.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 11, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• The patients' age will range from 35 to 55 years.
• The patients' weight range is from 60 to 85 kg and their height ranges from 155 to 170 cm.
• The total burned surface area (TBSA) is more than 40% measured by the rule of nine.
• Patients with thermal burn only, partial-thickness burn injury, and at least 3 months after burn injuries.
• Patients with low physical activity levels.

Exclusion Criteria:

• Patients with inhalation injury.
• Patients with leg amputation.
• Patients with any limitation in lower limb range of motion.
• Patients with auditory or visual problems.
• Patients with congenital musculoskeletal deformities, especially in the foot.
• Patients with psychiatric disorders.
• Patients with lower limb paralysis.
• Patients with cardiac abnormalities or cardiac pacemakers.

Related Conditions & MeSH terms

• Burns
• Exercises
• Functional Performance
• Muscle Weakness

Intervention

Other:
• Wii fit exercises program
Wii fit exercises for balance training and lower limb strengthening for 30 minutes. In addition to warming up and cooling down, 10 minutes each in the form of a range of motion exercises and stretching.
• Pilates exercises program
Selected pilates exercises for balance training and lower limb strengthening: Articulating bridge, Spine stretch, Single leg stretch, Double leg stretch, Criss-cross, One leg kick, Side kick, Hip twist, and Standing footwork for 30 minutes, 10 repetitions each. In addition to the warming up and the cooling down exercises before and after the pilates exercises, 10 minutes each in the form of a range of motion exercises and stretching, and deep friction massage for scar management.
• Standard physical therapy program
All patients will receive the standard physical therapy program consisting of 45 minutes per session of a supervised and individualized exercise program for three sessions per week for eight weeks which will include: Stretching exercises for lower limb muscles, each stretch will be maintained for 45 seconds, 3 repetitions, strengthening exercises for lower limb muscles starting from 50 to 60% of 1 repetition maximum and the intensity will be increased gradually until 80 to 85 % through the treatments weeks.

Locations

Country	Name	City	State
Egypt	Shaimaa Mohamed Ahmed El Sayeh	Cairo	New Cairo
Egypt	Shaimaa Mohamed Ahmed El Sayeh	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isokinetic Muscle Strength Assessment	Isokinetic Muscle Strength Assessment will be assessed by A Biodex dynamometer (Biodex Medical System, Shirley, NY, USA). The values of knee flexors and extensors muscle peak torque of dominant leg were measured regardless the location of burns at an angular velocity of 150°/seconds, hip angle of 100° and patient were supported with a securing belt placed over the mid- thigh, pelvis and trunk. Three sub-maximal repetitions were allowed for the patient without any load as a warm-up. The patient then carried out 10 of maximum voluntary muscle contractions continuously without rest and the highest values were recorded for analysis.	Change from baseline at twelve weeks after the intervention
Primary	Dynamic balance score	The dynamic balance score will be measured by the Biodex Balance System (Biodex Medical System, Shirley, NY, USA). The Biodex Balance System is a valid and reliable method to assess dynamic balance.; A Biodex Balance System (Biodex Medical Systems, Shirley, NY) consists of a movable balance platform that provides a 20° surface tilt through a 360° range of motion. The platform interfaces with computer software that enables the device to serve as an objective assessment of balance. All measurements were performed at level eight of stability, and the test duration was set at 20 seconds for three successive trials	Change from baseline at twelve weeks after the intervention
Secondary	Functional exercise capacity	Six-minute walk test will be used to assess functional exercise capacity of the participants. The 6-MWT was performed in a 30-meters flat corridor according to the American Thoracic Society guidelines. Patients were asked to walk as far as possible in the 30-m corridor during the 6-min period. Standardized verbal encouragement is given to the patients during the 6-MWT. At the end of the test, the walking distance was measured. The predicted values of 6-MWT were calculated according to age and gender	Change from baseline at twelve weeks after the intervention