Combinational Rehabilitative Therapy and Functional Brain Imaging for Patients Recovering From Motor Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Changes in the Fugl Meyer Upper Limb score at the start and end of the two weeks trial period
研究概览
简要总结
The present proposal aims to assess whether a combined rehabilitation approach using virtual reality based therapy with motivational feedback, levodopa for pharmacotherapy and standard rehabilitative occupational therapy and physiotherapy will lead to signifcantly better outcomes for stroke recovery.
It is a randomised controlled trial with blinding of the assessors only. It will be preceeded by a Phase 1 pilot trial of the VR physiotherapy and standard therapy only. Recruited in-patient rehabilitation ward patients who have recently suffered stroke will be randomized, through a computer-based random number generator, to either one of two treatment arms:
- Control occupational therapy + pharmacotherapy for 2 weeks
- Assisted Virtual-Reality physiotherapy + pharmacotherapy for 2 weeks
详细描述
The study is designed as a single-blinded randomized controlled trial, preceeded by a Phase 1 pilot trial of the VR physiotherapy and standard therapy only.
Phase 1 will comprise of recruitment of up to 5 patients who have recently suffered a stroke who will be informed that they will receive ten 15- 30 minutes of VR therapy in addition to their standard stroke therapy. They will not receive any pharmacotherapy during this period. At the start and end of the VR phase, clinical assessment (Fugl-Meyer scores, Action Research Arm Test) will be made of each patient by a blinded clinician investigator.
From this data, calibration to the VR program will be made to ensure reproducibility of effectiveness of movements assessed.
Subsequently, for the main phase of the trial, recruited in-patients who have recently suffered stroke will be randomized, through a computer-based random number generator, to either one of two treatment arms:
- Control occupational therapy + pharmacotherapy
- Assisted Virtual-Reality physiotherapy + pharmacotherapy
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 25-99yrs
- •Right-handed
- •Cognitively coherent, able to provide informed consent (MMSE >25)
- •Newly diagnosed, first episode ischemic stroke in the past 2-21 days
- •Motor score: Strength of 2-3 out of 5 on affected side upper limb
排除标准
- •Declined consent to participate in the study
- •Cognitive impairment or significant aphasia with inability to understand study requirements and inability to participate in therapy
- •Other neurological or physical ailments with pre-existing motor weakness
- •Haemorrhagic stroke
- •Patient due to undergo significant medical interventions such as carotid endarthrectomy
- •Patients on neuroactive agents prior to the stroke such as antidepressants
- •Hypersensitivity to benserazide, levodopa, sympathomimetics, or any component of the formulation
- •Use of MAO inhibitors within the last 14 days
- •Patients with clinical or laboratory evidence of uncompensated cardiovascular, endocrine, renal, hepatic, hematologic, or pulmonary disease
- •Patients with decompensated endocrine, renal, hepatic, cardiac disorders, psychiatric disorders, narrow-angle glaucoma, or closed-angle glaucoma;
- •Patients <25 years of age (due to possibility of skeletal abnormalities from benserazide)
- •Pregnancy or use in women of childbearing potential without adequate contraception.
研究组 & 干预措施
Virtual Reality based therapy, levodopa
The VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table.
Patients will receive a single dose of 100mg levodopa in combination with benserazide 2-3 hours before each additional Occupational therapy session or VR therapy session depending on the assigned group.
干预措施: Levodopa (Drug)
Virtual Reality based therapy, levodopa
The VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table.
Patients will receive a single dose of 100mg levodopa in combination with benserazide 2-3 hours before each additional Occupational therapy session or VR therapy session depending on the assigned group.
干预措施: Virtual Reality based therapy (Other)
occupational therapy, levodopa
The control group will receive and additional half an hour per working day of standard occupational therapy.
Patients will receive a single dose of 100mg levodopa in combination with benserazide 2-3 hours before each additional Occupational therapy session or VR therapy session depending on the assigned group.
干预措施: Levodopa (Drug)
结局指标
主要结局
Changes in the Fugl Meyer Upper Limb score at the start and end of the two weeks trial period
时间窗: At the start and end of the 2 weeks period of trial therapy
Fugl Meyer Upper Extremity Scale (FM) - a clinical assessment of upper limb tone, power and movement.
次要结局
- Changes in the Action Research Arm Test (ARAT)(At the start and end of the 2 weeks period of trial therapy)
- Changes in the Functional independence measure score(At the start and end of the 2 weeks therapy period)