Antigravity Treadmill With Alter G on the Postural Stability of Traumatic Lower Limb Injuries
NCT ID: NCT05285020
Last Updated: 2022-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2022-06-01
2022-07-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The total of 30 patients participated in this study (n=30). There were 15 subjects in control group and 15 in experimental group.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gait Rehabilitation Following an Anterior Cruciate Ligament Reconstruction
NCT02930239
Antigravity Treadmill After Joint Arthroplasty
NCT07040878
Antigravity Treadmill Training on Gait Characteristics and Balance
NCT05493696
The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty
NCT02928562
Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains
NCT01117909
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Alter G group
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).
Alter G
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 Scale
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 protocol
It is the hospital's standard protocol for that injuries once a day for two weeks.
Control group
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.
Parallel bars and Scale
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 protocol
It is the hospital's standard protocol for that injuries once a day for two weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Alter G
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 Scale
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 protocol
It is the hospital's standard protocol for that injuries once a day for two weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Sex male and female
* Surgical or non-surgical subacute knee, ankle, and foot traumatic injuries
Exclusion Criteria
* Important dysmetry
* Neurological pathology
* Acute inflammatory diseases.
* Important degenerative diseases.
* Autoimmune diseases.
* Severe visual deficits.
* Tumor pathology.
25 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
FREMAP Mutual Insurance Company for Occupational Accidents and Diseases
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Esther Melero Baez
Principal Investigator
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTS954.EM1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.