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临床试验/NCT04673838
NCT04673838已完成不适用

The Effect of Lower Limb Sensory Training on Functional Capacity in Hemiparetic Individuals

Pamukkale University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Foot Sole Sense

研究概览

简要总结

The purpose of our study is to assess the effect of lower limb sensory training on proprioception, balance, gait and motor functions in Hemiparetic Individuals.

详细描述

After being informed about the study, all patients giving written informed consent will be determined eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a single-blind manner (investigor about assessments). A group will have Bobath Therapy and the other group Bobath and Sensory Training.

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
Single (Investigator)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for Intervention and Control Group:
  • Between the ages of 20-65 and discharged from the hospital,
  • Having been diagnosed with hemiparesis at least 4 weeks ago,
  • First time and one-sided hemiparesis,
  • Modified Rankin Score ≤3,
  • Hodkinson Mental Test ≥ 6,
  • Individuals who agree to having treatment will be included in the study.

排除标准

  • for Intervention and Control Group:
  • Having vision and hearing problems,
  • Having other neurological, psychiatric and / or orthopedic problems other than hemiparesis,
  • Medically unstable,
  • Have other diagnosed diseases that will affect lower extremity sensation,
  • Individuals with open wounds, circulatory problems, skin lesions in the area to be treated will be excluded from the study.

结局指标

主要结局

Foot Sole Sense

时间窗: 4 weeks

he evaluation will be done with Semmes Weinstein Monofilaments (SWM) in the supine position. Monofilaments will be held perpendicular to the surface, and they will be contacted for 1.5-2 seconds by pressing until there is a slight bend in the monofilament. Individuals will be informed to say "yes" when they feel the contact, and the responses obtained from the patient will be recorded. The application will be evaluated in seven regions on the sole of the foot: the big toe, the little toe, the first metatarsal, the fifth metatarsal, the lateral border of the foot, the medial border of the foot, and the medial border of the heel. Thicknesses in the test kit range have from 1.65 to 6.55. The 6.65 is the loss of protective sensation and is the worst result.

Balance Assessment

时间窗: 4 weeks

The device consists of two parts, an electronic inclination sensor and a moving platform. There is a red cross on the computer screen indicating the movement of the platform. The assessed person tries to keep this sign on the screen in the center for 30 seconds. At the end of the test, the device calculates a balance score.

Lower Extremity Position Test

时间窗: 4 weeks

It was developed for the evaluation of proprioseption after stroke. Two 12 cm and 22 cm lines are drawn in the middle of the A4 paper. The patient is seated on a flat chair and the toes are adjusted to match the tip of the paper. The eyes of the patient are closed, the tips of the toes are brought over the line twice passively, and in the next evaluation, the patient is informed about "stop" and the difference is recorded in cm. The smaller is the difference, the better is proprioseption.

Kinesthesia Sense

时间窗: 4 weeks

Measurement will be done with electrogoniometer in the sitting position. 60 degrees hip flexion, 60 degrees knee flexion and 10 degrees ankle plantar flexion angles will be performed on the healthy leg in 5 repetitions, then three measurements will be taken from the hemiparetic leg.

Evaluation of Gait Parameters

时间窗: 4 weeks

In the gait analysis system, the results are transferred to the computer via bluetooth with the analysis port attached to the patient's L5-S1 level. After walking, the resulting reports are automatically generated.

Functional Level

时间窗: 4 weeks

Motricity Index (MI) will be used to determine motor function levels. Since the lower extremity functions after hemiparesis are evaluated in the study, the lower extremity score of the Motricity Index will be calculated. In the lower extremity, hip flexion muscle strength, knee extension muscle strength, and ankle dorsi flexion muscle strength will be evaluated in the sitting position. Each muscle is evaluated over 33. The highest score obtained from the test is 100 and shows the best functionality.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulsum Tikac

Principal Investigator

Pamukkale University

研究点 (2)

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