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

NCT06081504 | Recruiting

• 1 other identifier: P.T.REC/012/004387
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Burns; Muscle Weakness; Exercises; Functional Performance

Keywords

Wii Fit exercises; Pilates exercises; muscle strength; postural balance; functional performance; lower extremity burn

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Functional exercise capacity

  Change from baseline at twelve weeks after the intervention

Study Arms (3)

Wii fit exercises group

EXPERIMENTAL

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; Other: Standard physical therapy program

Pilates exercises group

EXPERIMENTAL

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; Other: Standard physical therapy program

Standard physical therapy group

ACTIVE COMPARATOR

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

Interventions

Wii fit exercises program OTHER

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.

Wii fit exercises group

Pilates exercises program OTHER

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.

Pilates exercises group

Standard physical therapy program OTHER

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.

Pilates exercises group; Standard physical therapy group; Wii fit exercises group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Shaimaa Mohamed Ahmed El Sayeh

Cairo, New Cairo, 02, Egypt

RECRUITING

Shaimaa Mohamed Ahmed El Sayeh

Cairo, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Burns; Muscle Weakness; Motor Activity

Condition Hierarchy (Ancestors)

Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Shaimaa MA El Sayeh

  Lecturer at Faculty of Physical Therapy, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaimaa MA El Sayeh

CONTACT

+201007766160; sh.sayeh87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: October 13, 2023
• Study Start: October 10, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 11, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)