The Effectiveness of Radial Extracorporeal Shock Wave Therapy as Additional Treatment Modality for Spastic Equinus Deformity in Chronic Hemiplegic Patients, A Double-Blinded, Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Reduction in H/M ratio.
研究概览
简要总结
This is a prospective, double blinded randomized, placebo-controlled study that will be conducted on 112 adult ischemic or hemorrhagic hemiplegic stroke patients with calf muscles spasticity so as to evaluate the effectiveness of radial extracorporeal shock wave therapy (r ESWT) as an additional treatment modality for spastic equinus deformity in those patients. Allocation of patients into two groups after eligibility testing & randomization will be done:
Group I: patients will receive rESWT once weekly for one month , Group II: patients will receive Sham rESWT once weekly for one month. Each patient will be evaluated by the same well trained physiatrist for clinical, Electrophysiological and Musculoskeletal Ultrasound (MSKUS) assessments at baseline (t0), and after 1 month (t1) and after 2 months (t2) .
详细描述
Study design & Participants selection:
This is a prospective, randomized, placebo-controlled study that will be conducted from October 2022 to March 2023, on 112 consecutive adult ischemic or hemorrhagic hemiplegic stroke patients with calf muscles spasticity (grade 1 - 4) by the modified Ashworth scale (MAS) who will be recruited from out patient clinic of Rheumatology , Rehabilitation and Physical Medicine Department ,Tanta university Hospital, and will be assessed for study eligibility.
Inclusion criteria:
All patients who exhibited signs of unilateral spastic equinus foot for at least 6 months before the enrollment in the study will be selected to reduce the confounding effect of natural recovery.
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The closed envelop method will be used for the randomization of the patients who will be blinded to group allocation. The assessments will be done by the first physiatrist (A), who will not involved in patients' sessions. The randomization will be performed by the second physiatrist (B ) who will not be involved in patients' assessment and ESWT sessions . ESWT Sessions for both groups will be will be carried out by the third physiatrist (C ) who will not take part in the assessments or patients' randomization . Both (C) and (A) were blinded to group allocation.
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
- •Adult ischemic or hemorrhagic hemiplegic patients who exhibited signs of unilateral spastic equinus foot for at least 6 months before the enrollment in the study will be selected to reduce the confounding effect of natural recovery.
排除标准
- •Patients with fixed contractures or deformities at the ankle, fractures, cognitive impairment, different types of neuropathies or myopathies, implanted pacemaker and prior /or planned treatment using antispastic medications (i.e intrathecal baclofen or Botox injection ) or chemo -denervation ( phenol or alcohol nerve blocks ) within the last 6 months preceding the study , will be excluded.
结局指标
主要结局
Reduction in H/M ratio.
时间窗: about 6 months
Improvement of Passive ankle dorsiflexion range of motion ( PADFM) .
时间窗: about 6 months
Reduction in time required to walk 10 meters (10 MWT).
时间窗: about 6 months
Reduction in modified Ashworth scale (MAS) for spastic plantar flexor muscles
时间窗: about 6 months
Change in spastic calf muscles echogenicity on Heckmatt scale.
时间窗: about 6 months
次要结局
未报告次要终点
研究者
Doaa Waseem Nada
Principal investigator
Tanta University