Antigravity Treadmill Training on Gait Characteristics and Balance

NCT ID: NCT05493696

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2022-07-28

Brief Summary

Severe burn injuries are associated with hypermetabolic responses and increased catabolism. These generalized changes lead to a vast loss of muscle mass and cause reduced muscle strength and endurance, limited walking ability, and reduced functional mobility Recently, the antigravity treadmill or lower body positive pressure (LBPP) technology has been developed as a unique system of maintaining a participant's body weight all through treadmill training and developing low-load treadmill walking using a unique treadmill system that allows gaining the benefits of low-load treadmill walking without interrupting with locomotion dynamics

Detailed Description

Objective: This single-blind randomized controlled trial aimed to examine the effects of antigravity treadmill training on gait characteristics and balance in healed adult burned patients.

Methods: Fifty-five adult burn patients were chosen to participate in this study, their ages ranged from 18 to 35 years. They were randomly allocated to Alter G (ALG) (n=22), and control (Cont) (n=23) groups. The control group received a traditional physical therapy program (TPTP), three times per week. In contrast, the experimental group received antigravity treadmill training (30 minutes,3 times/week, speed 0.1 m/sec, 75% body weight) in addition to the traditional physical therapy program given to the control group. All study participants followed the instructions recommended for the exercise performed (three days per week) in terms of intensity, type, and duration to limit any difference between groups, as well as instructions about not exercising the rest of the week. During the study period, both groups received standard medical care. outcome measures: gait characteristics and postural stability indices were measured at the baseline (pre) and end of 12 weeks of intervention (post). The Statistical Package for the Social Sciences (SPSS) software was used for statistical analysis. The Shapiro-Wilk test was used to determine the normality of the data. The paired t-test was used to test within-group comparisons of mean changes in muscle strength, gait characteristics, and postural stability indices. The unpaired t-test was used to compare between groups. P<0.05 was chosen as the level of significance.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 (ALG+TPTP)

Patients received Antigravity treadmill training + Traditional physical therapy program

Group Type: EXPERIMENTAL

Antigravity treadmill

Intervention Type: DEVICE

Alter G training for 30-minute, 3 times/week, 75% body weight

Traditional physical therapy program

Intervention Type: OTHER

applied 3 times/week for 12 weeks

Group 2 (TPTP)

Patients received a Traditional physical therapy program

Group Type: ACTIVE_COMPARATOR

Traditional physical therapy program

Intervention Type: OTHER

applied 3 times/week for 12 weeks

Interventions

Antigravity treadmill

Alter G training for 30-minute, 3 times/week, 75% body weight

Intervention Type: DEVICE

Traditional physical therapy program

applied 3 times/week for 12 weeks

Intervention Type: OTHER

Other Intervention Names

Traditional physical therapy program

Eligibility Criteria

Inclusion Criteria

• Patients with circumferential lower limb deep second to third-degree thermal injury
• Burns extending from the lower trunk to the foot were considered
• The total body surface area (TBSA) ranges from 35 to 50%
• All patients completed the same physical therapy program during hospitalization peroid

Exclusion Criteria

• Lower limb prosthesis
• Severe musculoskeletal disorders
• Serious cardiovascular insult
• Participation in an outside physical training program
• Fracture
• Medication that negatively impacts the study's results
• Brain injury
• Vestibular disorders
• Visual disorders
• History of epilepsy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umm Al-Qura University

OTHER

Sponsor Role: lead

Responsible Party

Anwar Abdelgayed Ebid

Professor Physical Therapy, Faculty of Applied Medical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anwar Ebid, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor Physical Therapy

Locations

Faculty of Applied Medical Sciences

Mecca, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id