Antigravity Treadmill With Alter G on the Postural Stability of Traumatic Lower Limb Injuries (ALTERG20)

FREMAP

Status: Unknown

Conditions: Muscle Injury; Injury Traumatic; Bone Injuries Joints; Lower Limb Injury; Ligament Injury; Tendon Injuries

Treatments: Other: Parallel bars and Scale; Other: Standard rehabilitation protocol; Other: Alter G

Study type: Interventional

Funder types: Industry

Identifiers

NCT05285020

CTS954.EM1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 25 and 55
• Sex male and female
• Surgical or non-surgical subacute knee, ankle, and foot traumatic injuries

Exclusion criteria

• Vestibular pathology
• Important dysmetry
• Neurological pathology
• Acute inflammatory diseases.
• Important degenerative diseases.
• Autoimmune diseases.
• Severe visual deficits.
• Tumor pathology.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Alter G group

Experimental group

Description:

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).

Treatment:

Other: Alter G

Other: Standard rehabilitation protocol

Other: Parallel bars and Scale

Control group

Other group

Description:

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.

Treatment:

Other: Standard rehabilitation protocol

Other: Parallel bars and Scale