Altering Activation Patterns in the Distal Upper Extremity After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in Mean Completion Time for Graded Wolf Motor Function Test (GWMFT)
研究概览
简要总结
This study evaluates a new rehabilitation approach for stroke survivors in the chronic phase of recovery in which the combination of drug therapy (cyproheptadine) and active movement practice (AMP) is used to encourage increased voluntary muscle control and strength.
详细描述
In this four arm parallel design you will be randomly assigned to one of 4 groups:
Group 1) cyproheptadine and active movement therapy, Group 2) placebo and active movement therapy, Group 3) cyproheptadine and passive stretching, or Group 4) placebo and passive stretching.
The groups will be blinded so neither you nor the research staff (or even the study doctor) will know which drug (Cyproheptadine or placebo) you receive. Only the RIC pharmacist will have access to this information until all participants complete the entire study. Although you and the research staff administering the training sessions will know if you have been assigned to the active movement practice (AMP) or passive cyclical stretching group, it is important not to discuss this information with the rater (evaluator) or the study doctor.
Cyproheptadine is an anti-serotonergic and anti spastic agent. It is expected to reduce the unwanted muscle hyper excitability (one measure of spasticity) common after stroke.
During the course of the treatment you will be required to make several visits per week to RIC to either be evaluated or participate in the treatment sessions. Evaluations last approximately 2 hours and will be performed at the beginning of weeks 1, 2, 3 and 4, during the middle of treatment (beginning of week 7), at the end of training (beginning of week 10) as well as a final follow-up visit one month after the end of treatment (beginning of week 14). The training sessions will occur from weeks 4 through week 9 and will involve 1.5-hr. sessions (1 hr training plus setup time) 3 times per week.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Chronic, severe hand hemiparesis resulting from a single stroke (Chedoke- McMaster Stroke Assessment: Stage of Hand 2 or 3)
- •Single stroke occurring at least 6 months prior to enrollment
- •Spasticity
- •Capacity to provide informed consent
排除标准
- •Excessive pain in paretic upper limb
- •Hemispatial neglect (as assessed by the Behavioral Inattention Test)
- •Apraxia (as assessed by the FABERS battery)
- •Botulinum toxin injection in the upper extremity within the past 6 months
- •Introduction of new anti-spasticity medication within the past 6 months
- •Orthopaedic impairments
- •History of seizure disorder
- •Other major health impairment
研究组 & 干预措施
Placebo for Cyproheptadine + Stretching
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
干预措施: Passive Cyclical Stretching (Other)
Cyproheptadine + Stretching
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
干预措施: Passive Cyclical Stretching (Other)
Cyproheptadine + AMP
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
干预措施: Active Movement Practice (AMP) (Other)
Placebo for Cyproheptadine + AMP
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
干预措施: Active Movement Practice (AMP) (Other)
Placebo for Cyproheptadine + AMP
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
干预措施: Placebo for Cyproheptadine (Drug)
Placebo for Cyproheptadine + Stretching
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
干预措施: Placebo for Cyproheptadine (Drug)
Cyproheptadine + AMP
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
干预措施: Cyproheptadine (Drug)
Cyproheptadine + Stretching
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.
Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.
Dose will be titrated down to zero in the 2 weeks following treatment.
干预措施: Cyproheptadine (Drug)
结局指标
主要结局
Change in Mean Completion Time for Graded Wolf Motor Function Test (GWMFT)
时间窗: baseline and 9 weeks (immediately post intervention)
GWMFT is a clinical outcome measure comprised of 15 timed tasks focusing on upper extremity function. Maximum allowable time per task is 120 seconds.
次要结局
- Change in Grip Relaxation Time (Following a Maximum Voluntary Contraction (MVC)(baseline and 9 weeks (immediately post intervention))
研究者
Elliot Roth
Medical Director, Patient Recovery Unit, Attending Physician, RIC Professor & Chairman, PM&R, Northwestern Feinberg School of Medicine
Shirley Ryan AbilityLab