Influence of Antigravity Treadmill With Alter G on the Postural Stability of Patients With Traumatic Lower Limb Injuries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- LOS test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 25 and 55
- •Sex male and female
- •Surgical or non-surgical subacute knee, ankle, and foot traumatic injuries
排除标准
- •Vestibular pathology
- •Important dysmetry
- •Neurological pathology
- •Acute inflammatory diseases.
- •Important degenerative diseases.
- •Autoimmune diseases.
- •Severe visual deficits.
- •Tumor pathology.
结局指标
主要结局
LOS test
时间窗: 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.
Postural Stability test
时间窗: 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.
m-CTSIB test
时间窗: 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.
次要结局
未报告次要终点
研究者
Esther Melero Baez
Principal Investigator
FREMAP Mutual Insurance Company for Occupational Accidents and Diseases