Glove Rehabilitation Application for Stroke Patients (GRASP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
研究概览
简要总结
The University of Virginia (UVA) Director of Neurorehabilitation will lead GRASP randomized, controlled efficacy trials. The study will involve employment of the GRASP system in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment.
详细描述
Testing will involve employment of the GRASP system (glove orthosis, sensor package, and application software) in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment. This frequency and duration is consistent with previous studies successfully investigating new upper extremity (UE) therapies. The primary outcome of the efficacy study will be change in hand function for a group of participants using the GRASP system versus a control group receiving standard care over the same period.
Participants assigned to the GRASP intervention group will attend five outpatient clinic visits for consent, pre-assessment, and familiarization with the system, followed by an initial home visit and eight weeks (3x per week) of independent at-home practice. In this study period, GRASP intervention group participants will employ the instrumented glove orthosis while performing functional tasks within virtual activities of daily living (ADLs).
Participants in the Usual Care Treatment (UCT) control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT control group participants.
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 (Investigator)
盲法说明
Investigator administrating assessments will be blinded to subject group assignment.
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
- •Participant has had a right or left hemispheric stroke affecting normal hand function;
- •Participant has sufficient active finger flexion at the MCP joint in at least one finger to be detected by visual observation by a study therapist;
- •Participant has visual acuity with corrective lenses of 20/50 or better;
- •Participant's affected hand fits within sizing available for the glove orthosis;
- •Participant is no longer in an active UE rehabilitation program; and
- •Participant is currently living at a private residence and anticipates remaining at that location for the duration of study participation.
排除标准
- •Withholding or withdrawal of consent by the participant;
- •Inability to understand and follow verbal directions;
- •Determination by the Principal Investigator that participation would result in overexertion or significant discomfort or pain;
- •(3) A psychological diagnosis that in the determination of the Principal Investigator could significantly impact subject's participation or that could be aggravated by study participation (Principal Investigator will consult with candidate's personal physician as appropriate); (4) Determination by the Principal Investigator that participation would result in significant agitation or elevated stress; (5) Visual field deficit in either eye that impairs the ability to view the computer monitor; (6) Stiffness or contractures of the muscles, joints, tendons, ligaments, or skin that restricts normal movement; (7) More than mild tone/spasticity (measured on modified Ashworth, 5-point scale); (8) Severe contractures or joint deformities in the fingers; (9) Open wound or infection, severe edema, or excessive swelling which might interfere with wearing the glove; (10) Severe pre-stroke co-morbidities, such as cardiovascular, neurological, orthopedic, or rheumatoid impairments before stroke that may interfere with task performance; (11) Severe sensory deficits from the involved UE; or (12) Hemispatial neglect that impairs the ability to process and perceive visual stimuli provided through the computer monitor.
结局指标
主要结局
Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
时间窗: Pre-intervention at Baseline
FMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function.
Post Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
时间窗: Post Intervention at 8 weeks
FMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function.
次要结局
- Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)(Pre-intervention at Baseline)
- Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)(Post Intervention at 8 weeks)
- Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)(Pre-intervention at Baseline)
- Post Intervention Wolf Motor Function Test Time (WMFT-TIME)(Post Intervention at 8 weeks)
- Pre Intervention Box and Blocks Test (BBT)(Pre-intervention at Baseline)
- Post Intervention Box and Blocks Test (BBT)(Post Intervention at 8 weeks)
- Pre Intervention Motor Activity Log - Amount (MAL-Amount)(Pre-intervention at Baseline)
- Post Intervention Motor Activity Log - Amount (MAL-Amount)(Post Intervention at 8 weeks)
- Pre Intervention Motor Activity Log - How Well (MAL-How Well)(Pre-intervention at Baseline)
- Post Intervention Motor Activity Log - How Well (MAL-How Well)(Post Intervention at 8 weeks)