BurnsNCT05493696
Antigravity Treadmill Training on Gait Characteristics and Balance
A study testing Antigravity treadmill and Traditional physical therapy program in people with Burns, run by Umm Al-Qura University at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Burns
- What is being tested?
- Antigravity treadmill and Traditional physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jun 2022to 28 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Brain injury
- Vestibular disorders
- Visual disorders
- History of epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Burns
- Being tested
- Antigravity treadmill, Traditional physical therapy program
- Keywords
- Burn, Gait, Balance, Antigravity treadmill
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antigravity treadmillDevice
Also called Traditional physical therapy program
Alter G training for 30-minute, 3 times/week, 75% body weight
Traditional physical therapy programOther
applied 3 times/week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (ALG+TPTP) | Experimental | Patients received Antigravity treadmill training + Traditional physical therapy program Receives: Device: Antigravity treadmill; Other: Traditional physical therapy program |
| Group 2 (TPTP) | Active comparator | Patients received a Traditional physical therapy program Receives: Other: Traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait characteristics
Stride length (cm)
Measured: at baseline and after 12 weeks
Change in Gait characteristics
Step length (cm)
Measured: At baseline and after 12 weeks
Change in Gait characteristics
Velocity (cm/sec)
Measured: At baseline and after 12 weeks
Change in Gait characteristics
Cadence (step/mint)
Measured: At baseline and after 12 weeks
Change in Gait characteristics
Double support time (sec)
Measured: At baseline and after 12 weeks
Change in Postural stability indices
Medio-lateral Stability Index (MLI)
Measured: At baseline and after 12 weeks
Change in Postural stability indices
Antero-posterior Stability Index (API)
Measured: At baseline and after 12 weeks
Change in Postural stability indices
Overall Stability Index (OSI)
Measured: At baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start15 Jun 2022
- Primary completion15 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anwar Abdelgayed Ebid, Umm Al-Qura University
- Investigators
- Anwar Ebid, PhD, Principal investigator, Professor Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493696
- Sponsor's protocol ID
- 1
- Status last verified
- Aug 2022
- First submitted
- 30 Jul 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antigravity Treadmill (Alter G) Training on Gait Characteristics and Balance After Healed Adult Burns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05493696
- Acronym / sponsor ID
- 1
- Conditions
- Burns
- Keywords
- Burn, Gait, Balance, Antigravity treadmill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (ALG+TPTP) | Experimental | Device: Antigravity treadmill, Other: Traditional physical therapy programPatients received Antigravity treadmill training + Traditional physical therapy program |
| Group 2 (TPTP) | Active comparator | Other: Traditional physical therapy programPatients received a Traditional physical therapy program |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Lower limb prosthesis
- Severe musculoskeletal disorders
- Serious cardiovascular insult
- Participation in an outside physical training program
- Fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antigravity treadmillAlso: Traditional physical therapy programAlter G training for 30-minute, 3 times/week, 75% body weight | Device | Group 1 (ALG+TPTP) |
| Traditional physical therapy programapplied 3 times/week for 12 weeks | Other | Group 1 (ALG+TPTP), Group 2 (TPTP) |
Primary outcome
Change in Gait characteristics
Time frame: at baseline and after 12 weeks
Stride length (cm)
Change in Gait characteristics
Time frame: At baseline and after 12 weeks
Step length (cm)
Change in Gait characteristics
Time frame: At baseline and after 12 weeks
Velocity (cm/sec)
Change in Gait characteristics
Time frame: At baseline and after 12 weeks
Cadence (step/mint)
Change in Gait characteristics
Time frame: At baseline and after 12 weeks
Double support time (sec)
Change in Postural stability indices
Time frame: At baseline and after 12 weeks
Medio-lateral Stability Index (MLI)
Change in Postural stability indices
Time frame: At baseline and after 12 weeks
Antero-posterior Stability Index (API)
Change in Postural stability indices
Time frame: At baseline and after 12 weeks
Overall Stability Index (OSI)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anwar Ebid, PhD principal investigator
Professor Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antigravity treadmill and Traditional physical therapy program in people with Burns, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait characteristics (time frame: at baseline and after 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.