Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
Current protocols for therapy on a rehabilitation unit call for intensive rehabilitation composed of high intensity, long duration therapy. Evidence from brain healing and animal research, along with motor learning principles suggest that a treatment program composed of short duration therapy sessions distributed throughout the day may provide better rehabilitation outcomes for stroke patients. Such a program can be implemented using constraint-induced therapy in which the Veteran is provided with opportunities to use the affected limb while participating in a video game and completing complementary tasks in therapy. Additionally, rehabilitation outcomes may improve if Veterans are provided with regular opportunities to participate in gaming therapy at home after discharge from the hospital rather than having to travel to a clinic or receive limited or no follow-up in rural areas.
This project will develop a therapeutic model that promotes use of the impaired arm and hand. Researchers often call this type of therapy "constraint induced therapy". In this study, participants focus on using the impaired limb rather than the unaffected limb. A small group of patients will participate in a question and answer session about preferences for activities which make up transfer tasks. Up to twenty-four (24) Veterans inpatient with hemiparesis due to stroke in the brain will be recruited from the Minneapolis VA Health Care System. Study participants will only be able to play the game using the impaired limb. Participants may also receive automated reminders to use the impaired arm throughout the day. Gaming will occur in patient room and during occupational therapy. Participants will have the option of being discharged with the gaming system for continued gameplay. Outcome measures will include motor function tests that evaluate upper extremity function.
详细描述
Research Question
The two questions to be answered by this study are: 1) To what extent does game-based CI therapy (with the Transfer Package) increase use of the more affected upper extremity from inpatient rehabilitation through subacute follow-up.
- What is the clinical effectiveness of distributed gaming CI therapy for improving motor function of the more affected upper extremity at 3 months post-discharge.
Background
Constraint-Induced (CI) Movement therapy is arguably the best treatment paradigm to pilot throughout the continuum of care because it is established as the most empirically-supported intervention in subacute and chronic stroke and is more effective than standard care in acute stroke when lower duration/intensity protocols are utilized. CI therapy has strong evidence of increased effectiveness relative to standard care in the only positive definitively-powered upper extremity trial. A limitation of the acute CI therapy literature is that most studies omitted the most essential component of CI therapy: The Transfer Package of behavioral techniques that promotes carry-over of training to daily activities. In absence of the Transfer Package, everyday use of the weaker arm does not substantially improve and structural brain plasticity and quality of life gains are not realized. Early studies also show that any treatment advantage of CI therapy acutely is not maintained in follow-up, suggesting that maintenance therapy post-discharge is likely essential for altering the recovery trajectory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran between 18 and 88 years of age
- •Inpatient at the Minneapolis VAHCS
- •Willing and able to give Informed Consent or meets criteria for surrogate consent
- •Upper extremity hemiparesis resulting from stroke in the brain (including brainstem) or tumor resection at the discretion of the therapist
- •Lives within vicinity of the Minneapolis VA
排除标准
- •Complete loss of arm function
- •No contact address or telephone
- •Active substance use disorder or major uncontrolled psychiatric disorder
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: The ARAT was administered by OT at Day 0 (Enrollment), and discharge at 6 weeks post-enrollment for subject 1 and at 4 weeks post-enrollment for subject 2
The ARAT is a 19-item observational method used to assess upper extremity function on four subscales (grasp, pinch, gross movement, and grip). ARAT scores range from 0-57 points, with 57 points indicating no upper extremity impairment, and 0 points indicating no upper extremity movement.
Motor Activity Log (MAL) Change (Discharge MAL - Enrollment MAL)
时间窗: Performed at Day 0 (enrollment) and at discharge (at 6 weeks post-enrollment for subject 1 and 4 weeks post-enrollment for subject 2)
The Motor Activity Log (MAL) is a motivational tool to assist stroke survivors in identifying goal movements and tracking progress. The Quality of Movement (QOM) subscale has participants rate themselves on how well they perform various activities of daily living with their more affected arm on a 0-5 scale. Scores are averaged across items and range from 0-5, with higher scores indicating the participant's ability to use their affected arm just as well as before their stroke.
次要结局
- Wolf Motor Function Test (WMFT)(The WMFT may be administered by OT at at Day 0 (Enrollment), discharge, and potentially at 3 months post-discharge.)