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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06081504

Collaborator

(none)

Enrollment

Locations

Arms

4.1

Anticipated Duration (Months)

22.5

Patients Per Site

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Burns Muscle Weakness Exercises Functional Performance	Other: Wii fit exercises program Other: Pilates exercises program Other: Standard physical therapy program	N/A

Detailed 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 our knowledge there are no 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Forty-five patients of both sexes with healed LL burns will be allocated randomly into three groups: the Wii fit exercises group, the pilates exercises group, and the standard physical therapy group.Forty-five patients of both sexes with healed LL burns will be allocated randomly into three groups: the Wii fit exercises group, the pilates exercises group, and the standard physical therapy group.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 10, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 11, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wii fit exercises group Fifteen patients will be engaged in the Wii Fit exercises program for 30 minutes in addition to the standard physical therapy program, 3 sessions a week for 12 weeks.	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. Other: 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.
Experimental: Pilates exercises group Fifteen patients will be engaged in the Pilates exercises program for 30 minutes in addition to the standard physical therapy program, 3 sessions a week for 12 weeks.	Other: 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. Other: 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.
Active Comparator: Standard physical therapy group Fifteen patients will be engaged in the Standard physical therapy program (lower limb stretching and strengthening exercises and deep friction massage) for 45 minutes, 3 sessions a week for 12 weeks.	Other: 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.

Arm

Intervention/Treatment

Experimental: Wii fit exercises group

Fifteen patients will be engaged in the Wii Fit exercises program for 30 minutes in addition to the standard physical therapy program, 3 sessions a week for 12 weeks.

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.

Other: 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.

Experimental: Pilates exercises group

Fifteen patients will be engaged in the Pilates exercises program for 30 minutes in addition to the standard physical therapy program, 3 sessions a week for 12 weeks.

Other: 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.

Other: Standard physical therapy program

Active Comparator: Standard physical therapy group

Fifteen patients will be engaged in the Standard physical therapy program (lower limb stretching and strengthening exercises and deep friction massage) for 45 minutes, 3 sessions a week for 12 weeks.

Other: Standard physical therapy program

Outcome Measures

Primary Outcome Measures

Isokinetic Muscle Strength Assessment [Change from baseline at twelve weeks after the intervention]
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.
Dynamic balance score [Change from baseline at twelve weeks after the intervention]
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

Secondary Outcome Measures

Functional exercise capacity [Change from baseline at twelve weeks after the intervention]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.