Antigravity Treadmill Training on Gait Characteristics and Balance

Effect of Antigravity Treadmill (Alter G) Training on Gait Characteristics and Balance After Healed Adult Burns: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Device: Antigravity treadmill; Other: Traditional physical therapy program

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Mecca, Saudi Arabia, 715
    • Faculty of Applied Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (ALG+TPTP); Patients received Antigravity treadmill training + Traditional physical therapy program	Device: Antigravity treadmill; Alter G training for 30-minute, 3 times/week, 75% body weight; Other Names: Traditional physical therapy program; Other: Traditional physical therapy program; applied 3 times/week for 12 weeks
Active Comparator: Group 2 (TPTP); Patients received a Traditional physical therapy program	Other: Traditional physical therapy program; applied 3 times/week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gait characteristics	Stride length (cm)	at baseline and after 12 weeks
Change in Gait characteristics	Step length (cm)	At baseline and after 12 weeks
Change in Gait characteristics	Velocity (cm/sec)	At baseline and after 12 weeks
Change in Gait characteristics	Cadence (step/mint)	At baseline and after 12 weeks
Change in Gait characteristics	Double support time (sec)	At baseline and after 12 weeks
Change in Postural stability indices	Medio-lateral Stability Index (MLI)	At baseline and after 12 weeks
Change in Postural stability indices	Antero-posterior Stability Index (API)	At baseline and after 12 weeks
Change in Postural stability indices	Overall Stability Index (OSI)	At baseline and after 12 weeks

Collaborators and Investigators

• Sponsor: Umm Al-Qura University
• Investigators: Principal Investigator: Anwar Ebid, PhD, Professor Physical Therapy

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: July 30, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Balance; Gait; Burn; Antigravity treadmill
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No