Antigravity Treadmill Training on Gait Characteristics and Balance

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05493696
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: July 28, 2022

Study information

• Verified date: August 2022
• Source: Umm Al-Qura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 28, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Antigravity treadmill
Alter G training for 30-minute, 3 times/week, 75% body weight

Other:
• Traditional physical therapy program
applied 3 times/week for 12 weeks

Locations

Country	Name	City	State
Saudi Arabia	Faculty of Applied Medical Sciences	Mecca

Sponsors (1)

Lead Sponsor	Collaborator
Umm Al-Qura University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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