Evaluation of the Effectiveness of Biofeedback Rehabilitation in People After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
研究概览
简要总结
The aim of the research will be to evaluate rehabilitation using the biofeedback method in people after stroke.
详细描述
Study participants will be randomly assigned to a study group and a control group.
- Study group I - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Biometrics E-link device
- Study group II - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Stella Bio device
- Control group - will complete a standard spa rehabilitation program without biofeedback exercises.
The study participants will be patients admitted to the Spa and Rehabilitation Hospital in Iwonicz-Zdrój, Poland, after a late-stage stroke.
Patients will undergo continuous inpatient rehabilitation (3 weeks). The first examination will be conducted on the day of hospital admission, the second on the day of discharge, and the third (follow-up) 3 months after hospital discharge, during a follow-up visit.
Prior to the study, a socio-demographic questionnaire will be administered, including questions about education, marital status, and place of residence.
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
- 45 Years 至 80 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 45-80 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
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
- •failure to complete a 3-week rehabilitation stay
研究组 & 干预措施
Group I-Biofeedback method using the Biometrics E-link device and Health-resort based rehabilitation
The rehabilitation program will last three weeks, Monday through Friday. Patients will benefit from group and individual exercises (active and assisted exercises, manipulative exercises, PNF-based exercises, balance and breathing exercises), manual massage, and physical treatments such as laser therapy, jacuzzi, mud packs, carbonic acid therapy, TENS therapy, BIO-V lamp, and local cryotherapy. Additionally, patients will receive 30 minutes per day of hand biofeedback training using the Biometrics E-link device.
干预措施: Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices. (Other)
Group II -Biofeedback method using the Stella Bio device and Health-resort based rehabilitation.
The rehabilitation program will last three weeks, Monday through Friday. Patients will benefit from group and individual exercises (active and assisted exercises, manipulative exercises, PNF-based exercises, balance and breathing exercises), manual massage, and physical treatments such as laser therapy, jacuzzi, mud packs, carbonic acid therapy, TENS therapy, BIO-V lamp, and local cryotherapy. Additionally, patients will receive 30 minutes per day of hand biofeedback training using the Stella Bio device.
干预措施: Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices. (Other)
Health-resort based rehabilitation.
Health-resort based rehabilitation Control group - health-resort based treatments, without biofeedback training.
Health-resort based rehabilitation The rehabilitation programme will last 3 weeks from Monday to Friday. Patients will receive: group and individual exercises (active and assisted exercises, manipulative exercises, PNF-based exercises, balance and breathing exercises), manual massage, physical treatments such as laser, whirlpool, mud packs, carbonic acid therapy , TENS therapy, BIO-V lamp, local cryotherapy
结局指标
主要结局
Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
时间窗: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit
It consists of 33 items assessing motor function and reflexes. The patient can score a maximum of 66 points, where each item on the scale is rated as: 0=unable, 1=partially able, or 2=fully able to perform the movement
Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
时间窗: First examination - before the start of the rehabilitation program
It consists of 33 items assessing motor function and reflexes. The patient can score a maximum of 66 points, where each item on the scale is rated as: 0=unable, 1=partially able, or 2=fully able to perform the movement
Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
时间窗: Second examination - at the end of the three-week program
It consists of 33 items assessing motor function and reflexes. The patient can score a maximum of 66 points, where each item on the scale is rated as: 0=unable, 1=partially able, or 2=fully able to perform the movement
次要结局
- Hand grip strength(Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit)
- Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.(Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit)
- Manual skills, assessed with Box and Blocks test;(Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit)
- Assessment of proprioception Thumb Localizing Test (TLT)(Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit)
- Proprioception was assessed using a mirror tester for elbow flexion and dorsal and palmar flexion of the radiocarpal joint(Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit)
- Handgrip function, according Frenchay scale(Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit)
- Hand grip strength(First examination - before the start of the rehabilitation program)
- Hand grip strength(Second examination - at the end of the three-week program)
- Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.(First examination - before the start of the rehabilitation program)
- 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)
- Manual skills, assessed with Box and Blocks test;(First examination - before the start of the rehabilitation program)
- Manual skills, assessed with Box and Blocks test;(Second examination - at the end of the three-week program)
- Assessment of proprioception Thumb Localizing Test (TLT)(First examination - before the start of the rehabilitation program)
- Assessment of proprioception Thumb Localizing Test (TLT)(Second examination - at the end of the three-week program)
- Proprioception was assessed using a mirror tester for elbow flexion and dorsal and palmar flexion of the radiocarpal joint(First examination - before the start of the rehabilitation program)
- Proprioception was assessed using a mirror tester for elbow flexion and dorsal and palmar flexion of the radiocarpal joint(Second examination - at the end of the three-week program)
- Handgrip function, according Frenchay scale(First examination - before the start of the rehabilitation program)
- Handgrip function, according Frenchay scale(Second examination - at the end of the three-week program)
研究者
Justyna Leszczak
Principal Investigator
University of Rzeszow