Evaluation of the Effectiveness of Biofeedback Rehabilitation in Patients With Neurological Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Ranges of motion in the joints of the upper limb
研究概览
简要总结
The research will aim to evaluate biofeedback rehabilitation and optical oximetry assessment in neurological patients and the influence of blood parameters on the effect of the rehabilitation carried out.
An additional aim will be to evaluate components of body weight, lifestyle, dietary habits, assessment of mental state, quality of life among the study subjects.
详细描述
Prior to the study, an assessment of the reliability, reproducibility and validity of the devices among healthy individuals will be carried out.
The subjects will be allocated, by random selection, to two groups:
- a study group (60 subjects) - following a conventional rehabilitation programme supplemented additionally with biofeedback training
Study subjects:
- Post-stroke condition;
- Craniocerebral trauma;
- Multiple Sclerosis;
- Cerebral Palsy;
- Parkinson's disease
- Complete or partial spinal cord injury The group of subjects are patients staying at the Health Resort and Rehabilitation Hospital in Iwonicz Zdrój. The subjects will have a comprehensive rehabilitation with additional exercises/therapies using modern equipment (Biometrics, Luna EMG, HEG, Vectis, Rotor) with the biofeedback method (the study group). Control group - standard sanatorium rehabilitation programme without biofeedback exercises. Patients will have an ongoing rehabilitation period in hospital (3 weeks). The first examination will be carried out on the day of admission to hospital, the second examination on the day of discharge and, 3 months after leaving hospital, the third examination (follow-up) during the follow-up visit.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed, voluntary consent of the patient
- •age 21-75 years
- •elementary (basic) gripping ability
- •degree of paresis of the upper limb and hand 4 -5 on the Brunnström scale
- •degree of disability on the Rankin scale 3
- •spastic tension of the upper limb, paresis hand not more than 3 on the modified Ashworth scale - current health condition confirmed by a medical examination, allowing participation in tests and exercises
- •Test persons:
- •after a stroke;
- •Craniocerebral trauma;
- •Multiple sclerosis;
- •Cerebral Palsy;
- •Parkinson's disease
- •Total or partial spinal cord injury
排除标准
- •lack of informed, voluntary consent of the patient
- •second or subsequent stroke, hemorrhagic stroke, stroke of the brainstem and cerebellum
- •disorders of higher mental functions limiting comprehension and carrying out tasks during exercises
- •visual field disturbances
- •mechanical and thermal injuries that may limit the grasping function of the hand
- •concomitant neurological, rheumatological and orthopedic diseases, including permanent contractures that may affect the grasping ability and locomotion
- •unstable medical condition
- •metal implants, electronic implants, menstruation in women, epilepsy,
- •failure to complete a 3-week rehabilitation stay
结局指标
主要结局
Ranges of motion in the joints of the upper limb
时间窗: Second examination - at the end of the three-week program
with the use of R 500 goniometer; the device operates with an accuracy up to one degree.
ranges of movements in the shoulder joint
时间窗: Second examination - at the end of the three-week program
measurements performed on the Vectis , shoulder joint range of motion: flexion to 170, extension to 170
assessment of prioprioception (deep sensation)
时间窗: Second examination - at the end of the three-week program
Measurement performed on the Luna EMG device, selected range of motion with eyes closed 60 degrees elbow joint flexion
assessment of muscle tone (spasticity)
时间窗: Second examination - at the end of the three-week program
measurement performed on the Luna EMG machine, range of motion from 0 to 90 degrees elbow joint flexion
pinching strength of the fingers
时间窗: research among healthy people, during studies from the 3rd to the 5th year of studies
measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.
EMG of the extensors and flexors of the joints in the upper limb
时间窗: Second examination - at the end of the three-week program
EMG of the extensors and flexors of the upper limb joints - Biometrics and Luna device
Hand grip strength
时间窗: research among healthy people, during studies from the 3rd to the 5th year of studies
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,
optical oximetry
时间窗: Second examination - at the end of the three-week program
measurement performed with nIRS device, ranges: near infrared light (700-1300 nm) for oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb)
Change Body composition assessment (fat mass, visceral fat level , muscle tissue, fat free mass , water content in the body) subjected to bioelectrical impedancy analysis - Tanita 780.
时间窗: Second examination - at the end of the three-week program
Assessment of body composition (bioelectrical impedancy analysis - Tanita 780)
次要结局
- Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.(Second examination - at the end of the three-week program)
- Changes in blood parameter: atherogenic index(Second examination - at the end of the three-week program)
- Changes in blood parameter: total cholesterol(Second examination - at the end of the three-week program)
- Balance was assessed using Berg Balance Scale (BBS)(Second examination - at the end of the three-week program)
- Manual skills, assessed with Box and Blocks test;(Second examination - at the end of the three-week program)
- Handgrip function, according Franchay scale(Second examination - at the end of the three-week program)
- Changes in blood parameter: LDL(Second examination - at the end of the three-week program)
- Assessment of metabolic syndrome(Second examination - at the end of the three-week program)
- Changes in blood parameter: serum glucose(Second examination - at the end of the three-week program)
- Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.(Second examination - at the end of the three-week program)
- Assessment of paretic limb function was assessed using the Brunnström scale.(Second examination - at the end of the three-week program)
- Assessment of WHR(Second examination - at the end of the three-week program)
- Changes in blood parameter: TG(Second examination - at the end of the three-week program)
- Gross Motor Function Classification System (GMFCS)(Second examination - at the end of the three-week program)
- Changes in blood parameter: HDL(Second examination - at the end of the three-week program)
- Manual Ability Classification System (MACS)(Second examination - at the end of the three-week program)
- Changes in blood parameter: CRP(Second examination - at the end of the three-week program)
- Assessment of disability level, using the modified Rankin scale (MRS)(Second examination - at the end of the three-week program)
- Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale(Second examination - at the end of the three-week program)
研究者
Justyna Leszczak
Principal Investigator
University of Rzeszow