Injury TraumaticALTERG20NCT05285020
Antigravity Treadmill With Alter G on the Postural Stability of Traumatic Lower Limb Injuries
A study testing Alter G, Parallel bars and Scale and Standard rehabilitation protocol in people with Injury Traumatic and Muscle Injury, run by FREMAP Mutual Insurance Company for Occupational Accidents and Diseases.
Trial summary
This prospective randomised study aimed to test the investigators's hypothesis that anti-gravity treadmill therapy has beneficial effects on postural stability tests over a standard rehabilitation protocol in patients who have suffered traumatic injuries of the lower limb, demonstrating an improvement in the Biodex… Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Injury Traumatic, Muscle Injury, Bone Injuries Joints
- What is being tested?
- Alter G, Parallel bars and Scale and Standard rehabilitation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 24 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 25 and 55
- Sex male and female
- Surgical or non-surgical subacute knee, ankle, and foot traumatic injuries
Who cannot join
- Vestibular pathology
- Important dysmetry
- Neurological pathology
- Acute inflammatory diseases.
- Important degenerative diseases.
- Autoimmune diseases.
- Severe visual deficits.
- Tumor pathology.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence of Antigravity Treadmill With Alter G on the Postural Stability of Patients With Traumatic Lower Limb Injuries
This prospective randomised study aimed to test the investigators's hypothesis that anti-gravity treadmill therapy has beneficial effects on postural stability tests over a standard rehabilitation protocol in patients who have suffered traumatic injuries of the lower limb, demonstrating an improvement in the Biodex platform's values.
The total of 30 patients participated in this study (n=30). There were 15 subjects in control group and 15 in experimental group.
Read the detailed description
This prospective, randomised, controlled, longitudinal and triple-blind masked clinical design was performed in patients derived to the rehabilitation service of Fremap Sevilla Hospital after an laboral accident with surgery and not surgery traumatic injuries.
After that, participants were questioned about their personal data and the inclusion and exclusion criteria. All agreed to participate and provided signed informed consent prior to data collection.
Participants were allocated according to the inclusion and exclusion criteria into an intervention and a control group. The intervention was performed in two weeks. Patients were randomised into the intervention (anti-gravity treadmill) or control (standard protocol) rehabilitation group.
Previous data is taken from the "Postural Stability", "Stability Limits" and " m-CTSIB" tests on the Biodex Balance System SD platform.
The control group will perform the hospital's standard protocol for these injuries while the experimental group will also be added the anti-gravity treadmill in Alter G once a day.
At 2 week post-treatment, subjects were tested again. All patients were able to complete all rehabilitation sessions and balance tests.
Sample size assessment: accepting an alpha risk of 0.05 and a beta risk of 0.1 in a bilateral contrast, 15 subjects in each group are needed to detect a minimum difference of 15% between two groups, assuming that there are 2 groups and a standard deviation of 12%. A 10% rate of loss of insurance has been estimated.
Statistical analysis plan: the statistical analysis will be carried out using IBM-SPSS Statistics 24 software. The Kolmogorov-Smirnov test will be applied to test the distribution of the data. Student's t-test will be applied for paired variables when the data have a parametric distribution. The Mann-Whitney U test will be used to analyse data with a non-parametric distribution. The Chi-Squared will be used to compared qualitative variables. The confidence level used will be 95% (0.05) and the power of the study will be 90% (0.1).
- Conditions
- Injury Traumatic, Muscle Injury, Bone Injuries Joints, Tendon Injuries, Lower Limb Injury, Ligament Injury
- Being tested
- Alter G, Parallel bars and Scale, Standard rehabilitation protocol
- Keywords
- postural balance, lower limb, exercise therapy, rehabilitation, gait, body weight, injury traumatic
- Medical subject headings
- Wounds and Injuries, Tendon Injuries, Leg Injuries, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alter GOther
It is anti-gravity treadmill treatment on Alter G. They will start with a 30-50% body weight load during the first week that will be progressively increased to 50-70% during the second (5% more each day during the 10 sessions as far as possible).
The slope will be 0% and the speed 2-3km/h the first week and 3-4 km/h the second. Treatment will be performed during 15 minutes for two weeks (10 sessions).
Parallel bars and ScaleOther
It is a re-education of the gait at the parallel bars with a progressive load in scale controlled by the patient during 10 minutes for two weeks.
Standard rehabilitation protocolOther
It is the hospital's standard protocol for that injuries once a day for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alter G group | Experimental | This group will perform the hospital's standard protocol for these injuries once a day during two weeks.
They carried out the re-education of the gait (at the parallel bars) with a progressive load in scale controlled by the patient.
Also, they carried out a re-education of the gait and progressive loading in the system Alter G (anti-gravity treadmill). Receives: Other: Alter G; Other: Parallel bars and Scale; Other: Standard rehabilitation protocol |
| Control group | Other | This group will perform the hospital's standard protocol for these injuries once a day during two weeks.
They just carried out the re-education of the gait (at the parallel bars) with a progressive load in scale controlled by the patient. Receives: Other: Parallel bars and Scale; Other: Standard rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Stability test
The Postural Stability Test emphasizes a patient's ability to maintain center of balance. The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score.
Measured: Two weeks
LOS test
This test challenges patients to move and control their center of gravity within their base of sup- port. During each test trial, patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible. The same process is repeated for each of nine targets. Targets on the screen blink in random order.
Measured: Two weeks
m-CTSIB test
This test provides an assessment of a patient's ability to integrate multiple senses with respect to balance and compensate when one or more of these senses are engaged. This test will be performed under 4 different conditions. It will be carried out bilaterally, first with the static platform and then with the unstable rubber surface to increase the difficulty.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jun 2022 (estimated)
- Primary completion10 Jul 2022 (estimated)
- Study completion24 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury TraumaticStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FREMAP Mutual Insurance Company for Occupational Accidents and Diseases
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Esther Melero Baez, FREMAP Mutual Insurance Company for Occupational Accidents and Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285020
- Sponsor's protocol ID
- CTS954.EM1
- Acronym
- ALTERG20
- Status last verified
- Mar 2022
- First submitted
- 7 Nov 2021
- Last updated
- 17 Mar 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 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Antigravity Treadmill With Alter G on the Postural Stability of Patients With Traumatic Lower Limb Injuries
- ClinicalTrials.gov ID
- NCT05285020
- Acronym / sponsor ID
- ALTERG20 / CTS954.EM1
- Conditions
- Injury Traumatic, Muscle Injury, Bone Injuries Joints, Tendon Injuries, Lower Limb Injury, Ligament Injury
- Keywords
- postural balance, lower limb, exercise therapy, rehabilitation, gait, body weight, injury traumatic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- FREMAP Mutual Insurance Company for Occupational Accidents and DiseasesIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 10 Jul 2022 (estimated)
- Study completion
- 24 Jul 2022 (estimated)
- First posted
- 17 Mar 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.
This prospective randomised study aimed to test the investigators's hypothesis that anti-gravity treadmill therapy has beneficial effects on postural stability tests over a standard rehabilitation protocol in patients who have suffered traumatic injuries of the lower limb, demonstrating an improvement in the Biodex platform's values.
The total of 30 patients participated in this study (n=30). There were 15 subjects in control group and 15 in experimental group.
Detailed description
This prospective, randomised, controlled, longitudinal and triple-blind masked clinical design was performed in patients derived to the rehabilitation service of Fremap Sevilla Hospital after an laboral accident with surgery and not surgery traumatic injuries.
After that, participants were questioned about their personal data and the inclusion and exclusion criteria. All agreed to participate and provided signed informed consent prior to data collection.
Participants were allocated according to the inclusion and exclusion criteria into an intervention and a control group. The intervention was performed in two weeks. Patients were randomised into the intervention (anti-gravity treadmill) or control (standard protocol) rehabilitation group.
Previous data is taken from the "Postural Stability", "Stability Limits" and " m-CTSIB" tests on the Biodex Balance System SD platform.
The control group will perform the hospital's standard protocol for these injuries while the experimental group will also be added the anti-gravity treadmill in Alter G once a day.
At 2 week post-treatment, subjects were tested again. All patients were able to complete all rehabilitation sessions and balance tests.
Sample size assessment: accepting an alpha risk of 0.05 and a beta risk of 0.1 in a bilateral contrast, 15 subjects in each group are needed to detect a minimum difference of 15% between two groups, assuming that there are 2 groups and a standard deviation of 12%. A 10% rate of loss of insurance has been estimated.
Statistical analysis plan: the statistical analysis will be carried out using IBM-SPSS Statistics 24 software. The Kolmogorov-Smirnov test will be applied to test the distribution of the data. Student's t-test will be applied for paired variables when the data have a parametric distribution. The Mann-Whitney U test will be used to analyse data with a non-parametric distribution. The Chi-Squared will be used to compared qualitative variables. The confidence level used will be 95% (0.05) and the power of the study will be 90% (0.1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alter G group | Experimental | Other: Alter G, Other: Parallel bars and Scale, Other: Standard rehabilitation protocolThis group will perform the hospital's standard protocol for these injuries once a day during two weeks. They carried out the re-education of the gait (at the parallel bars) with a progressive load in scale controlled by the patient. Also, they carried out a re-education of the gait and progressive loading in the system Alter G (anti-gravity treadmill). |
| Control group | Other | Other: Parallel bars and Scale, Other: Standard rehabilitation protocolThis group will perform the hospital's standard protocol for these injuries once a day during two weeks. They just carried out the re-education of the gait (at the parallel bars) with a progressive load in scale controlled by the patient. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 25 and 55
- Sex male and female
- Surgical or non-surgical subacute knee, ankle, and foot traumatic injuries
Key exclusion criteria (8 listed)
- Vestibular pathology
- Important dysmetry
- Neurological pathology
- Acute inflammatory diseases.
- Important degenerative diseases.
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 |
|---|---|---|
| Alter GIt is anti-gravity treadmill treatment on Alter G. They will start with a 30-50% body weight load during the first week that will be progressively increased to 50-70% during the second (5% more each day during the 10 sessions as far as possible). The slope will be 0% and the speed 2-3km/h the first week and 3-4 km/h the second. Treatment will be performed during 15 minutes for two weeks (10 sessions). | Other | Alter G group |
| Parallel bars and ScaleIt is a re-education of the gait at the parallel bars with a progressive load in scale controlled by the patient during 10 minutes for two weeks. | Other | Alter G group, Control group |
| Standard rehabilitation protocolIt is the hospital's standard protocol for that injuries once a day for two weeks. | Other | Alter G group, Control group |
Primary outcome
Postural Stability test
Time frame: Two weeks
The Postural Stability Test emphasizes a patient's ability to maintain center of balance. The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score.
LOS test
Time frame: Two weeks
This test challenges patients to move and control their center of gravity within their base of sup- port. During each test trial, patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible. The same process is repeated for each of nine targets. Targets on the screen blink in random order.
m-CTSIB test
Time frame: Two weeks
This test provides an assessment of a patient's ability to integrate multiple senses with respect to balance and compensate when one or more of these senses are engaged. This test will be performed under 4 different conditions. It will be carried out bilaterally, first with the static platform and then with the unstable rubber surface to increase the difficulty.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 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.
Questions about this trial
What is this clinical trial studying?
A study testing Alter G, Parallel bars and Scale and Standard rehabilitation protocol in people with Injury Traumatic and Muscle Injury, run by FREMAP Mutual Insurance Company for Occupational Accidents and Diseases.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther Melero (+34695756832, esther_iya.emb@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Stability test (time frame: Two weeks). The study lists 3 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 17 Mar 2022; AzTrials last refreshed its copy on 26 Oct 2026.