跳至主要内容
临床试验/NCT05122273
NCT05122273Unknown不适用

Assessment of the Effectiveness of Muscle Activating Training With the Use of EMG Biofeedback in Patients With Neuromuscular Diseases

EGZOTech1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年11月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
8
试验地点
1
主要终点
Change in range of motion in upper and lower limb by goniometer

研究概览

简要总结

The aim of this study is to assess the impact of individually planned therapeutic procedures, using, among others, the concept of EMG biofeedback, to improve the general functional state, selected motor activities, stimulation and strength of specific muscle syndromes as well as postural parameters in children, adolescents and adults with neuromuscular diseases.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
3 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • confirmed genetic Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD), limb-girdle dystrophy, spinal muscular atrophy (SMA), myopathy or neuropathy
  • continued/uninterrupted rehabilitation process for 3 months
  • patient's condition allowing full understanding of commands

排除标准

  • patients using a respirator
  • painful complaints
  • after injuries and fractures in the last 6 months
  • significant weakening of muscle strength, preventing movements and activation of selected muscle groups, visible in the EMG examination
  • cognitive impairment-lack of or poor cooperation between the patient and the therapist,

结局指标

主要结局

Change in range of motion in upper and lower limb by goniometer

时间窗: baseline, after 12 weeks

Assessment of the changes in the range of motion in joints in the upper and lower limb measured by goniometer

Change in strength assessment

时间窗: baseline, after 12 weeks

Assessment of muscle strength using electrical dynamometer MicroFET2

Change in postural assessment by plurimeter (Rippstein)

时间窗: baseline, after 12 weeks

Spine curvature assessment in sagittal plane

Change in functional assessment

时间窗: baseline, after 12 weeks

Motor Function Measure Scale Each MFM32 item is scored on a 4-point Likert scale from 0 (cannot initiate the task) to 3 (performs the task fully). Item scores are summed, and the raw score is transformed to an overall total score ranging from 0 (severe functional impairment) to 100 (no functional impairment).

Change in EMG assessment

时间窗: baseline, after 12 weeks

EMG assessment using Stella BIO device

Hammersmith Functional Motor Scale Expanded

时间窗: baseline, after 12 weeks

It contains 33 items which are scored on a scale of 0, 1, 2 with a total achievable score of 66. Score 2 = performs without modification/adaptation/compensation Score 1 = performs with modification/adaptation/compensation Score 0 = unable to perform A total score can be achieved by summing the scores for all the individual items. The total score can range from 0, if all the activities are failed, to 66, if all the activities are achieved.

Change in postural assessment by scoliometer

时间窗: baseline, after 12 weeks

Assessment of the angle of the torso rotation in a sitting or standing position; Referral for scoliosis when rib slopeAngle of trunk rotation \[ATR\]is : 8 degrees for underweight patients, 7 degrees for normal-weight patients, 6 degrees for overweight patients, and 5 degrees for obese patients.

North Star Ambulatory Assessment

时间窗: baseline, after 12 weeks

17-item rating scale that is used to measure functional motor abilities in ambulant children with Duchenne Muscular Dystrophy. The activities are graded as follows: 2 - "Normal" - no obvious modification of activity 1 - Modified method but achieves goal independent of physical assistance from another 0 - Unable to achieve independently This scale is ordinal with 34 as the maximum score indicating fully-independent function.

次要结局

未报告次要终点

研究者

发起方
EGZOTech
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验