Randomised Controlled Trial to Evaluate the Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity (Repeated Botulinum Toxin Injections and Physiotherapy) on Impairment and Activity Limitation in Patients With Spastic Hemiparesis Following Stroke
试验速览
- 阶段
- 3 期
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Assessment of Goal Attainment Scaling (GAS).
研究概览
简要总结
The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections (BTI) and usual physiotherapy should increase the proportion of patients who attain their Primary Treatment Goal (impairments and function) more than usual care (involving repeated Botulinum Toxin Injections and conventional physiotherapy), in post stroke out-patients with spasticity.
详细描述
Stroke affects 150 000 persons in France each year. Most patients have activity limitations because of the resulting motor deficit and spasticity. Autonomy in activities of daily living is reduced.
The principal treatment for focal spasticity is currently intramuscular botulinum toxin injection (BTI).
BTI is classically combined with only 2 to 3 sessions of out-patient physiotherapy per week. This is mainly because of a lack of out-patient therapists. However, this amount of therapy is insufficient and does not follow current literature which shows that the intensity of physiotherapy affects the recovery of impairment and activity. This gap in our health system could be filled by a self-rehabilitation program in addition to physiotherapy.
Recent studies have shown that self-rehabilitation following BTI could significantly improve activity limitation (Roche et al, 2014 ; Sun et al 2010).
The addition of a self-rehabilitation program to BTI and usual out-patient physiotherapy could thus increase the effects of BTI on impairment and activity limitation in patients with spastic hemiparesis following stroke.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged between 18 to 75 years.
- •Adult patient under guardianship with consent obtained and the legal guardian's authorisation obtained.
- •Single stroke having occurred more than 6 months before (previous TIA is accepted).
- •Capable of understanding instructions and participating in the definition of a therapeutic goal (Boston Diagnostic Aphasia Examination (BDAE) < 3).
- •Having previously undergone BTI. The last injection must have been performed at least 4 months prior to inclusion.
- •Affiliation to the French social security regime or a similar regime.
- •Patient (or the legal guardian if under guardian adult patient) has signed the informed consent form.
排除标准
- •Patients who are unwilling to participate in the study. For the one under guardianship, the refusal of the patient will be the final decision even if the guardian is willing to participate.
- •Subjects who are unlikely to adhere to the study an/or poor adherence anticipated by the investigator.
- •Un-controlled progressive pathology.
- •Osteoarticular lesion which contraindicates part of the rehabilitation involved in the study.
- •Patients with other interventions planned prior to the end of the study period (orthosis, surgery etc.).
- •Surgery to the treated limb less than 6 months previously.
- •Pregnant woman.
结局指标
主要结局
Assessment of Goal Attainment Scaling (GAS).
时间窗: 6 months
The percentage of patients who attain their Primary Treatment Goal determined using Goal Attainment Scaling (GAS) at each visits and in both groups.
次要结局
- Quality of life questionnaire(6 months)
- Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment)(6 months)
- Assessment of the Functional Independence Measure (FIM)(6 months)
- Assessment of Hemispatial neglect(6 months)