The Feasibility of a Home-based Constraint-Induced Movement Therapy Program in Chronic Stroke Survivors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
研究概览
简要总结
The aim of this study is to evaluate the feasibility of a Home-based Constraint-Induced Movement Therapy (hCIMT) compared to a Modified Constraint-Induced Movement Therapy (mCIMT) delivered in a outpatient setting on upper limb motor recovery in stroke survivors.
详细描述
Home-based Constraint Induced Modified Therapy (hCIMT) consist of 2 hours intensive upper limb practice with shaping techniques + 2 hours ADLs supervised by a caregiver. Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.
Modified Constraint Induced Modified Therapy (mCIMT) consist of 2 hours intensive upper limb practice with shaping techniques supervised by an experienced physiotherapist + 2 hours ADLs at home (supervised by a caregiver) Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.
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)
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
- •age > 18 years and < 80 years
- •diagnosis of first ischemic stroke
- •stroke onset > 6 months prior to study enrollment
- •upper extremity hemiparesis with impairment of hand and/or arm:
- •active wrist extension ≥20º
- •active metacarpophalangeal- and interphalangeal-joints extension ≥ 10°
- •muscle tone assessed by the Modified Ashworth Scale (MAS) ≤ 2
- •pain assessed by the Visual Analogue Scale (VAS) <4
排除标准
- •anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
- •impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
- •contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
- •neurological or psychiatric pathology
- •severe cardio-pulmonary, renal, hepatic diseases
- •pregnancy
研究组 & 干预措施
mCIMT
2 hours intensive upper limb practice with shaping techniques supervised by an experienced physiotherapist + 2 hours ADLs at home (supervised by a caregiver) Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.
干预措施: mCIMT (Behavioral)
hCIMT
2 hours intensive upper limb practice with shaping techniques + 2 hours ADLs supervised by a caregiver.
Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.
干预措施: hCIMT (Behavioral)
结局指标
主要结局
Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
时间窗: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
次要结局
- Wolf Motor Function Test (WMFT)(1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up)
- Nine Hole Peg Test (NHPT(1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up)
- Motor Activity Log (MAL)(1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up)
- Motor cortex excitability (single pulse and paired pulse TMS)(1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up)
- Stroke Impact Scale 3.0 (SIS 3.0)(1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up)
- NIRS (Near Infrared Spectroscopy) NIRS measurements will be performed during 6 cycles of 15s hand reaching and grasping and 45s resting while sitting on a chair.(1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up)