Effects of Control of Joint Degrees of Freedom in the Early Rehabilitation Post-stroke for the Recovery of Normal Movement (Non-compensatory) of the Upper Limb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Functioning Outcome 1
研究概览
简要总结
The study's methodology will be a single-blind, multicenter, parallel-group randomized controlled trial (RCT). The sample consists of stroke patients (supratentorial ischemic and hemorrhagic stroke of anterior territory) between 18 and 80 years of age, separated into 2 groups of 20 participants. The experimental group called "controlled DoF", the control group 1 called "non controlled DoF". The "controlled DoF" group will use an exoskeleton that will restrict the movement of the trunk and upper limb to release only the joint to work in the plane of interest. The "non-controlled DoF" group will receive the same therapy time as the previous group but without any restriction of joint movements. The training will be functional with multiarticular and combined planes tasks. All groups receive the conventional rehabilitation of the health center (ideally 45 minutes 1 per day). Using motion sensors, clinical scales, and electroencephalography (EEG), the data will be obtained pre-intervention, post-intervention, and in a follow-up at 3 and 6 months.
详细描述
This proposal seeks to demonstrate if the control of joint degrees of freedom (DoF) of the trunk and upper limb is determinant during the early rehabilitation phase post-stroke (here from day 1 to day 28 or first month) for the recovery of upper limb movements without compensations and the normal brain control (true recovery).
The study's methodology will be a single-blind, multicenter, parallel-group randomized controlled trial (RCT). The sample consists of stroke patients (supratentorial ischemic and hemorrhagic stroke of anterior territory) between 18 and 80 years of age, separated into 2 groups of 20 participants. The experimental group called "controlled DoF", the control group 1 called "non controlled DoF". The "controlled DoF" group will receive for the initial 2 weeks, 2 hours of therapy, 5 times a week (2 sessions of 1 hour per day, 5 days) and the next 2 weeks, 2 hours of therapy, 3 times a week(2 sessions of 1 hour of therapy, 3 days), using an exoskeleton that will restrict the movement of the trunk and upper limb to release only the joint to work in the plane of interest. The training will be selective in an articulation plane with the biofeedback of active movements (or active-assisted) employing a video game controlled by an external movement sensor installed in the segment of interest. The "non-controlled DoF" group will receive the same therapy time as the previous group but without any restriction of joint movements. The training will be functional with multiarticular and combined planes tasks. All groups receive the conventional rehabilitation of the health center (ideally 45 minutes 1 per day). Using motion sensors, clinical scales, and electroencephalography (EEG), the data will be obtained pre-intervention, post-intervention, and in a follow-up at 3 and 6 months.
The expected results would show more functional improvements with less compensatory kinematics for therapy that control DoF than for the therapy without control of the DoF or for conventional therapy in acute post-stroke patients. About this result, the EEG connectivity analysis would show a lower interhemispheric inhibition of the motor areas and a greater frontal-parietal flow during reaching and manipulation tasks in the group with DoF control.
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 (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The outcomes assessors will not now the arm to which each participant corresponds
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) Clinical diagnosis of supratentorial ischemic stroke.
- •(2) Time of onset <72 hours.
- •(3) With alterations of the active voluntary movement of UL.
- •(4) At least 3/8 DoF of the UE with MRC force scale of 3 or less.
排除标准
- •(1) Cognitive impairment that prevents signing informed consent, following instructions and understanding procedures. (MoCA ≥ 18).
- •(2) Musculoskeletal pathologies that prevent activities without pain or with limited ranges for the scope.
- •(3) Severe visual impairment that does not allow the activities associated with the task.
- •(4) Cerebellar o brainstem stroke.
- •(5) Previous stroke leaving upper limb impairment.
- •(6) Bilateral sensorimotor alterations.
- •(7) Do not present alterations in functional clinical tests.
研究组 & 干预措施
Controlled DoF
The treatment that this gruop will receive consist in a training with the exoskeleton that will restrict the DoF of the arm and trunk
干预措施: Training with restriction of the DoF (Behavioral)
Non controlled DoF
The treatment that this gruop will receive consist in a training with out the exoskeleton and without restriction of the DoF
干预措施: Training without restriction of the DoF (Behavioral)
结局指标
主要结局
Functioning Outcome 1
时间窗: At week 1
Scale scores of Fugl Meyer Upper Limb test
Normal movements Outcome. Kinematics of grasping and reaching 4
时间窗: At week 24
Joint angles of the upper extremity in a glass test
Connectivity Outcome 1
时间窗: At week 1
Interhermispheric coherence of beta bands in the EEG.
Normal movements Outcome. Kinematics of grasping and reaching 1
时间窗: At week 1
Joint angles of the upper extremity in a water glass test
Normal movements Outcome. Kinematics of grasping and reaching 2
时间窗: At week 5
Joint angles of the upper extremity in a water glass test
Functioning Outcome 2
时间窗: At week 5
Scale scores of Fugl Meyer Upper Limb test
Normal movements Outcome. Kinematics of grasping and reaching 3
时间窗: At week 12
Joint angles of the upper extremity in a water glass test
Functioning Outcome 4
时间窗: At week 24
Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome - function of the arm 3
时间窗: At week 12
Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - function of the arm 4
时间窗: At week 24
Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - quality of life 2
时间窗: At week 5
Scale scores of EQ-5D (quality of life test)
Functioning Outcome 3
时间窗: At week 12
Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome - function of the arm1
时间窗: At week 1
Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - daily life activities 1
时间窗: At week 1
Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - function of the arm 2
时间窗: At week 5
Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - daily life activities 2
时间窗: At week 5
Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - daily life activities 3
时间窗: At week 12
Scale scores of Barthel Index (independence in daily life activities)
Connectivity Outcome 4
时间窗: At week 24
Interhermispheric coherence of beta bands in the EEG.
Functioning Outcome - daily life activities 4
时间窗: At week 24
Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - quality of life 1
时间窗: At week 1
Scale scores of EQ-5D (quality of life test)
Functioning Outcome - quality of life 3
时间窗: At week 12
Scale scores of EQ-5D (quality of life test)
Functioning Outcome - quality of life 4
时间窗: At week 24
Scale scores of EQ-5D (quality of life test)
Connectivity Outcome 2
时间窗: At week 5
Interhermispheric coherence of beta bands in the EEG.
Connectivity Outcome 3
时间窗: At week 12
Interhermispheric coherence of beta bands in the EEG.
次要结局
未报告次要终点
研究者
Pablo Burgos
Principal Investigator
University of Chile