跳至主要内容
临床试验/NCT05133232
NCT05133232已完成不适用

Effect of SynPhNe Physio-neuro Platform on Hand Motor Function Rehabilitation of Acute and Subacute Stroke Patients

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2019年7月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Change of upper extremity performance (coordination, dexterity and functioning) using Action Research Arm Test

研究概览

简要总结

Stroke is a major cause of adult long term disability and the fourth leading cause of death and affects 1·8/1000 persons in Singapore. Post-stroke functional recovery of upper limb is poor with 80% of stroke survivors having some upper limb disability during the acute to subacute phase after stroke. Early rehabilitation is paramount for enhancing the survival and independence of stroke patients and inadequate supervised therapy hours is closely associated with poor rehabilitation outcome. However, high intensity and high repetition therapies, which facilitates neuroplasticity, have historically had a poor uptake because it is manpower intensive and places a high demand on stroke patients, many of whom cannot cope. High fatigue and sustained levels of effort are also generally perceived as placing the patient at risk if done at home without trained supervision.

Robotic rehabilitation system can provide high-intensity, repetitive, task-specific, interactive treatment of the impaired upper limb and can serve as an objective and reliable means of monitoring patient progress.

Stroke subjects also have a wide spectrum of disability resulting in unconscious co-contractions and compensatory muscle use. Although these disability elements are widely acknowledged to be present, technological tools for identifying and quantifying these are missing. This technology gap affects the optimization of therapy and the patients' understanding of their condition.

This study aims:

  1. To investigate the feasibility and efficacy of using the SynPhNe device outside of conventional therapy time, compared with conventional occupational therapy alone, on hand motor function in acute and subacute stroke patients;
  2. To evaluate the feasibility of the use of SynPhNe by acute and subacute stroke patients with minimized supervision;
  3. To investigate subject and staff perceptions in terms of usability and benefit of the device;
  4. To study clinical outcomes, EEG, EMG and TMS changes over the course of the study;
  5. To compare the cost-benefit of SynPhNe therapy on inpatients with standard care.

Hypotheses:

  1. SynPhNe therapy will have added benefit compared to conventional occupational therapy alone on hand motor function in acute and subacute stroke patients;
  2. SynPhNe can be used with minimal supervision by acute and subacute stroke patients so that the efficiency of rehabilitation is increased;
  3. SynPhNe therapy is a cost-effective inpatient rehabilitation option.

详细描述

Stroke is a major cause of adult long term disability and the fourth leading cause of death and affects 1·8/1000 persons in Singapore. Post-stroke functional recovery of upper limb is poor with 80% of stroke survivors having some upper limb disability during the acute to subacute phase after stroke. Early rehabilitation is paramount for enhancing the survival and independence of stroke patients and inadequate supervised therapy hours is closely associated with poor rehabilitation outcome. However, high intensity and high repetition therapies, which facilitates neuroplasticity, have historically had a poor uptake because it is manpower intensive and places a high demand on stroke patients, many of whom cannot cope. High fatigue and sustained levels of effort are also generally perceived as placing the patient at risk if done at home without trained supervision.

Robotic rehabilitation system can provide high-intensity, repetitive, task-specific, interactive treatment of the impaired upper limb and can serve as an objective and reliable means of monitoring patient progress. However, robotic rehabilitation technologies have not had the wide-ranging impact that was once expected. Not only are they difficult to afford for the general population but their training options are limited, with most of them allowing basic joint movements such as wrist extension, finger extension and the like, rather than actual everyday tasks and activity level training. Those devices that provide a wider variety of everyday task training are more complex and expensive and few are designed to be used at home.

Stroke subjects also have a wide spectrum of disability which includes muscle weakness, lack of control, cognitive deficits, joint pain, and deeply embedded, maladaptive muscle couplings resulting in unconscious co-contractions and compensatory muscle use. Although these disability elements are widely acknowledged to be present, technological tools for identifying and quantifying these are missing. This technology gap affects the optimization of therapy and the patients' understanding of their condition. In many cases, patients are unable to grasp why there is no visible progress despite sincere effort, leading to discouragement and an eventual drop out of therapy. Conversely, a therapist may conclude no further improvement is feasible and place the patient on maintenance exercises. It is well known that patients may be required to follow different therapy roadmaps for hand function depending on the nature and extent of deficits. This would involve not just strength training but also co-ordination, organization, and goal-based execution. To be truly effective, a rehabilitation platform must be able to deliver a wide range of tasks and activities in a guided manner while measuring incremental as well as overall performance in a quantitative manner.

In this study, we intend to fill the gap using SynPhNe- a physio-neuro platform. It can provide an early, repetitive and task-specific hand rehabilitation with less supervision using correct muscle groups and muscle synergies of stroke patients. It also can engage physical and cognitive aspects of stroke patients. We had previously conducted a study using the SynPhNe device in chronic stroke patients and found an average of 6.3% improvement in the upper extremity component of the Fugl-Meyer score (p=0.015), and a 22% improvement in the Action Research Arm test (p=0.003) after a 4 week intervention (DSRB 2012/00521). Just as with conventional therapy, we expect that the effect will be more pronounced in the acute to sub-acute stages of stroke when there is a greater degree of neuronal plasticity. Hence, we propose this study, where we intend to explore the use of the SynPhNe to: 1) increase the time the stroke-affected hand is used in therapeutic activity; 2) improve the effectiveness of upper extremity rehabilitation; 3) reduce the length of inpatients hospital stay.

Specific study aims: 1) To investigate the feasibility and efficacy of using the SynPhNe device outside of conventional therapy time, compared with conventional occupational therapy alone, on hand motor function in acute and subacute stroke patients; 2. To evaluate the feasibility of the use of SynPhNe by acute and subacute stroke patients with minimized supervision; 3. To investigate subject and staff perceptions in terms of usability and benefit of the device; 4. To study clinical outcomes, EEG, EMG and TMS changes over the course of the study; 5. To compare the cost-benefit of SynPhNe therapy on inpatients with standard care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome measures will be conducted by a study staff who is blinded to the allocation of the subject.

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hemiparetic stroke (haemorrhagic or ischaemic) within 4 months of recruitment;
  • FMA UE less than 55 (out of maximum of 66) but able to extend at least 2 fingers in the affected hand 10 degrees at any joint with pain-free passive range of motion at least 50% in all joints below the elbow;

排除标准

  • Cognitive or language impairment resulting in inability to follow instructions or inability to sustain attention for more than 10 minutes or inability to give consent;
  • Poor sitting balance (inability to sustain unsupported sitting for > 10min)
  • Other orthopaedic or neurological diseases other than stroke affecting the function of the stroke-affected arm;
  • severe pain in the stroke affected upper limb
  • Terminal diseases with expected survival <1 year
  • Women who are pregnant or breastfeeding
  • Patients who are in medically unstable conditions.

研究组 & 干预措施

SynPhNe physio-neuro platform

Experimental

Subjects will receive 15 to18 sessions of training at 60 minutes each on the use of the SynPhNe physio-neuro platform, for over the course of 4 weeks, outside of their conventional occupational therapy in accordance to a study protocol.

干预措施: SynPhNe physio-neuro platform (Device)

Conventional occupational therapy

No Intervention

Subjects will receive conventional occupational therapy (OT) only.

结局指标

主要结局

Change of upper extremity performance (coordination, dexterity and functioning) using Action Research Arm Test

时间窗: Change of upper extremity performance after intervention, Change of upper extremity performance 4 weeks after intervention

Upper limb function, Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.

Change of cortical excitability using Transcranial Magnetic Stimulation (TMS)

时间窗: Change of cortical excitability after intervention, Change of cortical excitability 4 weeks after intervention

measures of cortical excitability for those without TMS contraindications

Change of the upper extremity motor function using Fugl-Meyer scale

时间窗: Change of the upper extremity motor function after intervention, Change of the upper extremity motor function 4 weeks after intervention

Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.

Change of Grip strength % using Dynamometer

时间窗: Change of Grip strength % after intervention, Change of Grip strength % 4 weeks after intervention

Upper limb function

次要结局

  • Change of finger dexterity using 9-hole peg test(Change of finger dexterity after intervention, Change of finger dexterity 4 weeks after intervention)
  • Change of spasticity using Modified Ashworth scale(Change of spasticity after intervention, Change of spasticity 4 weeks after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验