Antigravity Treadmill Training on Gait Characteristics and Balance
Primary Purpose
Burns
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Antigravity treadmill
Traditional physical therapy program
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Burn, Gait, Balance, Antigravity treadmill
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
Sites / Locations
- Faculty of Applied Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1 (ALG+TPTP)
Group 2 (TPTP)
Arm Description
Patients received Antigravity treadmill training + Traditional physical therapy program
Patients received a Traditional physical therapy program
Outcomes
Primary Outcome Measures
Change in Gait characteristics
Stride length (cm)
Change in Gait characteristics
Step length (cm)
Change in Gait characteristics
Velocity (cm/sec)
Change in Gait characteristics
Cadence (step/mint)
Change in Gait characteristics
Double support time (sec)
Change in Postural stability indices
Medio-lateral Stability Index (MLI)
Change in Postural stability indices
Antero-posterior Stability Index (API)
Change in Postural stability indices
Overall Stability Index (OSI)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05493696
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burn, Gait, Balance, Antigravity treadmill
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (ALG+TPTP)
Arm Type
Experimental
Arm Description
Patients received Antigravity treadmill training + Traditional physical therapy program
Arm Title
Group 2 (TPTP)
Arm Type
Active Comparator
Arm Description
Patients received a Traditional physical therapy program
Intervention Type
Device
Intervention Name(s)
Antigravity treadmill
Other Intervention Name(s)
Traditional physical therapy program
Intervention Description
Alter G training for 30-minute, 3 times/week, 75% body weight
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy program
Intervention Description
applied 3 times/week for 12 weeks
Primary Outcome Measure Information:
Title
Change in Gait characteristics
Description
Stride length (cm)
Time Frame
at baseline and after 12 weeks
Title
Change in Gait characteristics
Description
Step length (cm)
Time Frame
At baseline and after 12 weeks
Title
Change in Gait characteristics
Description
Velocity (cm/sec)
Time Frame
At baseline and after 12 weeks
Title
Change in Gait characteristics
Description
Cadence (step/mint)
Time Frame
At baseline and after 12 weeks
Title
Change in Gait characteristics
Description
Double support time (sec)
Time Frame
At baseline and after 12 weeks
Title
Change in Postural stability indices
Description
Medio-lateral Stability Index (MLI)
Time Frame
At baseline and after 12 weeks
Title
Change in Postural stability indices
Description
Antero-posterior Stability Index (API)
Time Frame
At baseline and after 12 weeks
Title
Change in Postural stability indices
Description
Overall Stability Index (OSI)
Time Frame
At baseline and after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anwar Ebid, PhD
Organizational Affiliation
Professor Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Applied Medical Sciences
City
Mecca
ZIP/Postal Code
715
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
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Antigravity Treadmill Training on Gait Characteristics and Balance
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