Feasibility of Using Prism Adaptation to Treat Spatial Neglect and Motor Function in Stroke
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|ClinicalTrials.gov Identifier: NCT02419222|
Recruitment Status : Completed
First Posted : April 17, 2015
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: Prism Adaptation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Using Prism Adaptation to Treat Spatial Neglect and Motor Function in Stroke Survivors With Multiple Lesions|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Prism Adaptation
Prism Adaptation Treatment is 20 minutes long, administered 10 consecutive days
Behavioral: Prism Adaptation
PAT uses wedged prism lenses to displace the entire visual field horizontally to the left or right (depending on the orientation of the base of the prism). The left-base prism lenses (thicker on the left) shift the entire visual field to the right. The result is a curving reaching trajectory, aiming toward the image location (right to the actual location) and then corrected toward the actual location. After several reaching movement, the coordinates of motor and visual systems are aligned, which in other words, is that the motor output adapts to the visual input, and thus the reaching trajectory is straight ahead to the object. This visually-guided goal-oriented movement is essential in PAT.
- CBS via Kessler Foundation Neglect Assessment Process [ Time Frame: 30 minutes ]The CBS is a 10-item scale for evaluating the severity of spatial neglect (Azouviet al., 1996). Thus, the CBS captures the heterogeneity of spatial neglect in the most functional way. The items include limb awareness, personal belongings, dressing, grooming, gaze orientation, auditory attention, navigation, collisions, eating, cleaning after a meal. Each item is scored from 0-3. Based on a CBS total score (range 0-30), a stroke survivor with unilateral brain damage can be categorized as no neglect (CBS=0), mild (CBS= 1-10), moderate (CBS= 11-20), or severe (CBS= 20-30). In 2012, Chen et al. addressed this obstacle by standardizing the method to use the CBS reliably in the clinic and trademarked the process to use in conjunction with the CBS as the Kessler Foundation Neglect Assessment Process (CBS via KF-NAP™).
- Behavior Inattention Test [ Time Frame: 15 minutes ]The Behavior Inattention Test is a validated, widely used battery for the assessment of neglect. It has multiple subtests in the conventional battery, for example line crossing and letter cancelation tests . The conventional test battery will be used; the total score is out of 146 with a cut off score of 128 for spatial neglect (Wilson, et al. 1987).
- Motor Activity Log [ Time Frame: 15 minutes ]The Motor Activity Log, a structured interview, will be used to assess how the patient feels they use their arm during specific activities (Uswatte, Taub, Morris, Vignolo, McCulloch, 2005). This will be the outcome measure used to determine spontaneous movement.
- Functional Independence Measure [ Time Frame: 30 minutes ]Functional Independence Measure (FIM) is a reliable and valid assessment of function and the gold standard in rehabilitation facilities. It consists of 18 items assessing the level of independence in two domains; motor and cognitive. Each item is scored from 1 (maximal) to 7 (independent) (Ottenbacher, et al 1996).
- Wolf Motor Function Test [ Time Frame: 45 min ]The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks (Wolf et al., 1989). There are 21 items with 3 parts (time, functional ability and strength). The person's less affected arm is examined followed by the most affected side. The maximum score is a 75.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419222
|United States, New Jersey|
|Kessler Insitute for Rehabilitaiton|
|Saddle Brook, New Jersey, United States, 07663|
|Kessler Institute for Rehabiltiation|
|West Orange, New Jersey, United States, 07052|
|Principal Investigator:||Kimberly P Hreha, MS||Kessler Foundation|