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

NCT05285020 | Unknown

• 1 other identifier: CTS954.EM1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Two weeks

Study Arms (2)

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).

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.

Other: Parallel bars and Scale; Other: Standard rehabilitation protocol

Interventions

Alter G OTHER

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).

Alter G group

Parallel bars and Scale OTHER

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.

Alter G group; Control group

Standard rehabilitation protocol OTHER

It is the hospital's standard protocol for that injuries once a day for two weeks.

Alter G group; Control group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• FREMAP Mutual Insurance Company for Occupational Accidents and Diseases: lead

MeSH Terms

Conditions

Wounds and Injuries; Tendon Injuries; Leg Injuries; Body Weight

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Esther Melero

CONTACT

+34695756832; esther_iya.emb@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2021
• First Posted: March 17, 2022
• Study Start: June 1, 2022
• Primary Completion: July 10, 2022
• Study Completion: July 24, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share