A Comparison of Prism Adaptation Training (PAT) Paired With Transcutaneous Electrical Stimulation (TENS) vs PAT Alone on Outcomes in Post-Stroke Patients Experiencing Unilateral Spatial Neglect (USN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in unilateral spatial neglect functional deficits
研究概览
简要总结
This study aims to find out if doing two treatments together-Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS)-will help people who have had a stroke pay better attention to one side of their body, better than just doing PAT by itself.
In addition to understanding how the intervention improves function the investigators would like to see if things like how old someone is, how long ago their stroke happened, where their brain was damaged, or how bad the neglect is, affect how well the treatment works.
To measure if the interventions make a difference the following outcome measures will be used.
Catherine Bergego Scale (CBS):
This is a test to see how severe someone's neglect is. Trained therapists use 10 simple tasks to check if a person is ignoring the left or right side.
Wolf Motor Function Test (WMFT):
This test checks how well a stroke survivor can move their arm. It helps the therapists see if the treatments improve movement and reaction time
People can join the study if they had a stroke, score at least "1" on the Catherine Bergego Scale, and they can understand and agree to take part in the study.
People cannot join the study if they have had more than two strokes, have or had seizures, or have a serious mental illness like schizophrenia, or have cancer in the arm that was affected by the stroke, they have a pacemaker or defibrillator in their body, and if they can't feel their arm on the side affected by the stroke
Once the study is done, the main results will be shared with the therapists who work at the NeuroRehab and Balance Center, like the physical, speech, and occupational therapists.
详细描述
Unilateral spatial neglect (USN) is a common and disabling consequence of stroke, particularly following right-hemisphere lesions, affecting up to 50-70% of survivors. USN impairs a patient's ability to attend to or interact with stimuli on the side opposite the brain lesion, leading to significant challenges in daily functioning and rehabilitation engagement. The presence of USN is associated with poorer functional outcomes, increased dependence, and prolonged recovery after a stroke. Prism Adaptation Training (PAT) is a non-invasive intervention that has emerged as a promising approach for USN rehabilitation. PAT involves repeated visuomotor activities while wearing prism glasses that shift the visual field, promoting adaptation and recalibration of spatial attention. Multiple studies and systematic reviews have demonstrated that PAT can improve neglect symptoms, enhance motor control of the affected limb, and improve activities of daily living (ADL), with effects persisting for weeks to months post-intervention. However, the optimal dosing, duration, and potential for augmenting the effects of PAT remain areas of ongoing investigation. Transcutaneous Electrical Nerve Stimulation (TENS) is another non-invasive modality widely used in post-stroke rehabilitation. TENS delivers mild electrical currents through the skin to stimulate nerves and has shown efficacy in improving motor function, reducing spasticity, and enhancing functional recovery in stroke survivors. It has been shown to enhance upper limb function in individuals who have experienced a stroke. While TENS is primarily used for motor and sensory rehabilitation, its potential to modulate cortical excitability and facilitate neuroplasticity suggests it may also influence cognitive domains, including attention and spatial processing. There is evidence suggesting that TENS can have an impact on neglect. Despite the individual benefits of PAT and TENS in post-stroke rehabilitation, limited research has explored their combined effects on USN. The rationale for pairing PAT with TENS is based on the hypothesis that TENS-induced sensory stimulation may help enhance awareness of neglected space when applied to the upper extremity of individuals experiencing neglect, thereby potentially amplifying the adaptive effects of PAT on spatial neglect. However, the synergistic potential of TENS to enhance cognitive-perceptual rehabilitation strategies like PAT in the context of USN has not been systematically investigated. Given the persistent functional burden of USN and the need for more effective and accessible rehabilitation protocols, a pilot study comparing PAT paired with TENS versus PAT alone could provide critical preliminary evidence. Such research may identify whether adjunctive TENS can accelerate or enhance recovery from neglect, inform optimal intervention strategies, and ultimately improve independence and quality of life for stroke survivors experiencing USN.
The research question:
Is the combination of Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS) more effective than PAT alone in reducing unilateral spatial neglect (USN) in individuals' post-stroke?
Hypothesis: The combination of Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS) will be more effective than PAT alone in reducing unilateral spatial neglect (USN) in individuals post-stroke.
Primary study aim:
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
- None
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
- •A diagnosis of stroke
- •Score 1 or above on the Catherine Bergego Scale
- •Cognitively able to consent
排除标准
- •Seizure disorder
- •Diagnosed with more than two strokes
- •Diagnosis of schizophrenia or schizoaffective disorder
- •Cancer diagnosis of upper extremity
- •Individuals with pacemakers and debrillators
- •Absent sensation of upper extremity affected by stroke
结局指标
主要结局
Change in unilateral spatial neglect functional deficits
时间窗: From enrollment to discharge from therapy services which is typically 8-12 weeks
The Catherine Bergego Scale (CBS) is the selected outcome measure for assessing the severity of Unilateral Spatial Neglect (USN) and for evaluating changes in function and neglect following interventions. The CBS includes 10 subtests designed to identify both the presence and severity of USN. Maximum score on the CBS is 30 which indicates severe neglect, minumum score is 0 which indicates no neglect.
Change in motor control deficits
时间窗: From time of enrollment to discharge from therapy services typically 8-12 weeks
The Wolf Motor Function Test (WMFT) is a standardized assessment tool widely used to measure upper extremity motor abilities in individuals recovering from a stroke. This test serves as an outcome measure for motor control, assessing motor ability via a performance time and a Functional Ability Scale (FAS) of 15 subtests. During the timed tests subjects are allowed a maximum of 120 seconds per task. If a person cannot complete the task within 120 seconds the time is recorded as 120+. The official WFMT time score is the median time of 15 timed tasks. The FAS is calculated using a 6-point ordinal scale from 0-5. A higher score indicates better movement (0 = does not attempt to use the affected limb to 5=movement appears normal). The FAS score is calculated by averaging scores across all subtests.
次要结局
未报告次要终点