A Novel Approach to the Development of New Treatment Strategies to Enhance True Recovery After Stroke, Based on Laboratory Movement Analysis and Clinical Aspects of Gait Function and Walking
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Fugl-Meyer score (FMA-LE)
研究概览
简要总结
The purpose of this study is to elucidate pathophysiological mechanisms behind gait disturbances during the early recovery phase after hemiparetic stroke to identify targets for new treatment strategies.
Using an explorative, observational study design, pathophysiological mechanisms at play during the early recovery phase will be monitored, by repeated clinical assessments during inpatient rehabilitation as well as examinations of muscle activation patterns, kinematics of walking, corticospinal and reticulospinal function < 1 month, 3 and 6 months after hemiparetic stroke.
Inclusion: Eligible patients will have suffered a stroke, verified by CT or MRI examination and are admitted to inpatient care at the University Department of Rehabilitation Medicine Danderyd Hospital (RUDS). Thirty patients will be included consecutively. With an anticipated loss of 4-10 patients, at least 20 are expected to complete the study.
The clinical assessment protocols include standardized measures for the assessment of clinical and self-perceived aspects of functioning and disability. These assessments will be performed and repeated < 1 month, at 3 months and 6 months post-stroke by a therapist not responsible for rehabilitation interventions. At each of these assessment instances, laboratory movement analysis including electromyography (EMG) and ultrasound of the lower extremity muscle will be performed. In addition, a short assessment of body function and activity will be performed weekly during inpatient rehabilitation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with hemiplegia, dependence in ambulation (1- 4 according to the Functional Ambulation Categories (FAC)),
- •>= 50 points on the Trunk Control Test.
- •Impaired dorsiflexion manifested as impaired voluntarily dorsiflexion and inability to hold the ankle in a dorsiflexed position while sitting, and for ambulatory participants, impaired dorsiflexion during swing phase and initial contact during visual inspection of gait.
- •Recommended for an ancle foot orthosis (AFO) by an experienced physiotherapist. Able to understand study information and provide informed consent.
排除标准
- •Contracture that severely restricts gait movements in a lower limb joint,
- •cardiovascular or other somatic condition incompatible with intensive gait training,
- •notifiable infectious disease, contagious infections (e.g. MRSA or ESBL)
- •Inability to participate in the rehabilitation intervention due to behavioral or psychiatric disorder
- •when magnetic resonance imaging will be performed, additional exclusion criteria are current or history of epilepsy, metal implants in the brain/skull cochlear implants, any implanted neurostimulator, cardiac pacemaker or cardiac implants of metal and infusion device.
结局指标
主要结局
Fugl-Meyer score (FMA-LE)
时间窗: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Assesses sensory and movement related functions in the lower extremity (0p max impairment summed up to 86p max no detected impairment)
次要结局
- Motion analysis during gait(At baseline, at 3 and 6 months to assess change.)
- Monofilament(At baseline, at 3 and 6 months to assess change.)
- Falls Efficacy Scale (FES-S)(At baseline and at 3 and 6 months to assess change.)
- The Montreal Cognitive Assessment (MoCa)(At baseline and at 3 and 6 months to assess change.)
- National Institute of Health Stroke Scale(At baseline and at 3 and 6 months to assess change.)
- Electromyography (EMG)(At baseline, at 3 and 6 months to assess change.)
- Passive range of motion in the lower extremity(At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.)
- Neuroflexor(At baseline, at 3 and 6 months to assess change.)
- Modified Ashworth scale 0-5(At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.)
- 6 minutes walk test(At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.)
- The 10 meter walk test(At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.)
- Rated Perceived Exertion (RPE) Scale(At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.)
- The Balance evaluation systems test (BEST-test)(At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.)
- Navigated Transcranial magnetic stimulation (nTMS)(At baseline and at 3 and 6 months to assess change.)
- Numeric rating scale of pain(At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.)
- Walking impact scale (Walk-12)(At baseline and at 3 and 6 months to assess change)
- The Functional Ambulation Categories (FAC)(At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.)
- Barthel Index(At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.)
- Pain drawing(At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.)
- Medical Research Council scale(At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.)