Clinical trial NCT05493696: Antigravity Treadmill Training on Gait Characteristics and Balance
Official title: Effect of Antigravity Treadmill (Alter G) Training on Gait Characteristics and Balance After Healed Adult Burns: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: Burn
Gait
Balance
Antigravity treadmill
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Gait characteristics
timeFrame: at baseline and after 12 weeks
measure: Change in Gait characteristics
timeFrame: At baseline and after 12 weeks
measure: Change in Gait characteristics
timeFrame: At baseline and after 12 weeks
measure: Change in Gait characteristics
timeFrame: At baseline and after 12 weeks
measure: Change in Gait characteristics
timeFrame: At baseline and after 12 weeks
measure: Change in Postural stability indices
timeFrame: At baseline and after 12 weeks
measure: Change in Postural stability indices
timeFrame: At baseline and after 12 weeks
measure: Change in Postural stability indices
timeFrame: At baseline and after 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Faculty of Applied Medical Sciences
Study officials:
affiliation: Professor Physical Therapy
name: Anwar Ebid, PhD
role: PRINCIPAL_INVESTIGATOR
References: