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Completed

NCT Number: NCT05493696

Antigravity Treadmill Training on Gait Characteristics and Balance

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

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Key information

Conditions

Burns Wounds and Injuries

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Applied Medical Sciences

Mecca, 715, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antigravity treadmill

Device

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

Other names: Traditional physical therapy program

Traditional physical therapy program

Other

applied 3 times/week for 12 weeks

Primary outcomes

  1. Change in Gait characteristics

    Time frame: at baseline and after 12 weeks

    Stride length (cm)

  2. Change in Gait characteristics

    Time frame: At baseline and after 12 weeks

    Step length (cm)

  3. Change in Gait characteristics

    Time frame: At baseline and after 12 weeks

    Velocity (cm/sec)

  4. Change in Gait characteristics

    Time frame: At baseline and after 12 weeks

    Cadence (step/mint)

  5. Change in Gait characteristics

    Time frame: At baseline and after 12 weeks

    Double support time (sec)

  6. Change in Postural stability indices

    Time frame: At baseline and after 12 weeks

    Medio-lateral Stability Index (MLI)

  7. Change in Postural stability indices

    Time frame: At baseline and after 12 weeks

    Antero-posterior Stability Index (API)

  8. Change in Postural stability indices

    Time frame: At baseline and after 12 weeks

    Overall Stability Index (OSI)

Sponsors and collaborators

Lead sponsor

Umm Al-Qura University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2022
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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