Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis: A Multi-Centre, Single-Blind, Randomized Parallel Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 8
- 主要终点
- Change in the motor part of the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scale, calculated from baseline to post-intervention (2 weeks)
研究概览
简要总结
The study aims at demonstrating the efficacy of self-modulated functional electrical stimulation (SM-FES) in promoting upper-limb (UL) motor recovery in chronic stroke patients with severe and severe-moderate paralysis.
The effect of such experimental therapy will be compared to dose-matched, goal-oriented standard care (SC).
SM-FES consists of intensive, goal-oriented, repetitive functional exercises assisted by electrical stimulation. The patient actively self-administers the electrical stimulation on the impaired limb by controlling the electrical stimulation device with the non-impaired hand.
The duration of the intervention is 90 min per day, 5 days per week, for 2 weeks.
详细描述
After the informed consent process, each centre will screen potential participants according to the inclusion and exclusion criteria.
Each recruited participant will be randomly assigned to one group:
- experimental group - patients will receive self-modulated functional electrical stimulation SM-FES;
- control group - patients will receive standard care SC.
This first main phase of the study includes 10 days intervention delivered to the two groups and assessments pre-intervention, post-intervention and after 3 months (follow-up).
After the follow-up, participants initially recruited in the control group will be able to enter a secondary exploratory phase and receive further 10 days of treatment with SM-FES.
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)
盲法说明
As the two interventions (SM-FES and SC) are different in appearance for both the participant and the therapist providing the therapy session, only the assessor (i.e., person administering the outcome tests) will be kept blinded to treatment condition.
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
- 否
入选标准
- •diagnosis of one, first-ever ischemic stroke verified by brain imaging (i.e. computed tomography or magnetic resonance imaging);
- •chronic impairment after stroke, i.e. time since event ≥ 6months;
- •severe and severe-moderate upper limb impairment, i.e. FMA-UE score ≤ 34;
- •18 ≤ age < 80;
- •ability to give consent, understand the device use and follow instructions.
排除标准
- •an unstable recovery stage, measured as a difference between screening and baseline examinations of more than 3 points in the motor part of the FMA-UE scale;
- •contraindications and risk factors to neuromuscular electrical stimulation;
- •severe hemi-spatial neglect or anosognosia involving the affected arm, as determined by the Bells tests (> 6 errors);
- •severe impairment of proprioception, as evaluated from the blinded detection and discrimination of imposed passive movements (≥ 20° extension or flexion) of the finger proximal joint (>3 errors out of 6 mobilisations);
- •severe impairment of tactile sensing in the hand, as assessed by Semmes-Weinstein monofilament test (no detection of the 5.88 size evaluator);
- •excessive spasticity, as indicated by a score > 2 in any of the items of the REsistance to PASsive movement (REPAS) arm subtest;
- •recurrent, moderate to high upper limb pain limiting delivery of rehabilitation dose, i.e. pain at rest and in correspondence of a passive range of motion lower than 50%;
- •botulinum toxin injection into affected upper extremity during 3 months before the study or during the study;
- •history of physical / medical conditions interfering with study procedure, for example shoulder subluxation, upper extremity injury that limits the function of the hand or arm, skin lesion/rash/open wound on the affected upper extremity, or similar;
- •history of neurological condition interfering with study procedure, e.g. Parkinson's disease, progressive brain diseases like dementia and tumours;
- •use of antipsychotic medications;
- •enrolled in the past six months in another study involving drugs, biologics, upper limb experimental therapy, or similar.
结局指标
主要结局
Change in the motor part of the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scale, calculated from baseline to post-intervention (2 weeks)
时间窗: From baseline to post-intervention (2 weeks)
The FMA-UE measures the upper limb motor impairment. FMA-UE consists of 33 items. Each item is scored on a 3-point ordinal scale (0, 1, and 2) with 0 generally corresponding to no function, 1 to partial function, and 2 to perfect function. The items are summed to the final maximal score of 66 (no impairment).The FMA may also be divided into shoulder/elbow and wrist/hand sub-scores consisting of 18 and 15 tasks, with a maximum score of 36 and 30, respectively. Higher scores indicate less impairment.
次要结局
- Number and proportion of patients with change of at least 5 FMA-UE points from baseline (T0) to 2 weeks (T2) post-intervention and 3 months (T3) follow-up(From baseline (T0) to 2 weeks (T2) post-intervention and 3 months (T3) follow-up)
- Change of hand and arm spasticity measured by the REsistance to PASsive movement (REPAS) from baseline to post-intervention (2 weeks) and to 3 months follow-up(From baseline to post-intervention (2 weeks) and to 3 months follow-up)
- Change of perceived upper limb function measured by the Motor Activity Log (MAL) from baseline to post-intervention (2 weeks) and to 3 months follow-up(From baseline to post-intervention (2 weeks) and to 3 months follow-up)
- Change of the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scale at 3 months (T3) compared to baseline (T0)(At 3 months (T3) compared to baseline (T0))
- Change of upper limb function measured by the Action Research Arm test (ARAT) from baseline to post-intervention (2 weeks) and to 3 months follow-up(From baseline to post-intervention (2 weeks) and to 3 months follow-up)