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

Primary Purpose

Burns, Muscle Weakness, Exercises

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Wii fit exercises program
Pilates exercises program
Standard physical therapy program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Wii Fit exercises, Pilates exercises, muscle strength, postural balance, functional performance, lower extremity burn

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept 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. 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.

Sites / Locations

  • Shaimaa Mohamed Ahmed El SayehRecruiting
  • Shaimaa Mohamed Ahmed El SayehRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Wii fit exercises group

Pilates exercises group

Standard physical therapy group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
October 7, 2023
Last Updated
October 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06081504
Brief Title
Wii Fit Exercises Versus Pilates Exercises in Adult Patients With Lower Extremity Burn
Official Title
Wii Fit Exercises Versus Pilates Exercises on Muscle Strength, Postural Balance, and Functional Performance in Adult Patients With Lower Extremity Burn
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2023 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Muscle Weakness, Exercises, Functional Performance
Keywords
Wii Fit exercises, Pilates exercises, muscle strength, postural balance, functional performance, lower extremity burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wii fit exercises group
Arm Type
Experimental
Arm Description
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.
Arm Title
Pilates exercises group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard physical therapy group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Wii fit exercises program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pilates exercises program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard physical therapy program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Isokinetic Muscle Strength Assessment
Description
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.
Time Frame
Change from baseline at twelve weeks after the intervention
Title
Dynamic balance score
Description
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
Time Frame
Change from baseline at twelve weeks after the intervention
Secondary Outcome Measure Information:
Title
Functional exercise capacity
Description
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
Time Frame
Change from baseline at twelve weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaimaa MA El Sayeh
Phone
+201007766160
Email
sh.sayeh87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaimaa MA El Sayeh
Organizational Affiliation
Lecturer at Faculty of Physical Therapy, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaimaa Mohamed Ahmed El Sayeh
City
Cairo
State/Province
New Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaimaa MA El Sayeh
Phone
01007766160
Email
sh.sayeh87@gmail.com
First Name & Middle Initial & Last Name & Degree
Zainab A Ali, PhD
Facility Name
Shaimaa Mohamed Ahmed El Sayeh
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaimaa MA El Sayeh, PhD
Phone
+201007766160
Email
sh.sayeh87@gmail.com
First Name & Middle Initial & Last Name & Degree
zainab A ALI, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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