Condition or disease | Intervention/treatment | Phase |
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Stroke Brain Injuries Spatial Neglect Attention Deficit | Behavioral: c-SIGHT (computorized spatial innatention grasping home-based therapy) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Investigating a Portable Patient-led Virtual Reality Platform for Assessment and Rehabilitation of Hemispatial Neglect: a Usability Study |
Actual Study Start Date : | May 6, 2019 |
Estimated Primary Completion Date : | February 1, 2020 |
Estimated Study Completion Date : | April 3, 2020 |
Arm | Intervention/treatment |
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Experimental: c-SIGHT
SIGHT requires participants to grasp and lift rods with their less impaired arm.
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Behavioral: c-SIGHT (computorized spatial innatention grasping home-based therapy)
C-SIGHT will be self-administered at people's homes. c-SIGHT is a computerized therapy administered via people's television. The therapy involves performing repeated rod lifts with the less impaired arm in response to auditory and visual instructions presented on the television screen connected to a laptop. A small motion-tracking camera monitors rod lifts during therapy sessions. People will be asked to self-administer c-SIGHT for 1 hour a day (30min after breakfast and 30min after lunch) for 7 consecutive days. The first day of therapy will be performed with a therapist there for training purposes.
Other Name: visuomotor feedback training
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Standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations. The scale also measures self-awareness of behavioral neglect (anosognosia).
The CBS uses a 4-point rating scale to indicate the severity of neglect for each item:
0 = no neglect
This results in a total score out of 30.
Azouvi et al. (2002, 2003) have reported arbitrary ratings of neglect severity according to total scores:
0 = No behavioral neglect 1-10 = Mild behavioral neglect 11-20 = Moderate behavioral neglect 21-30 = Severe behavioral neglect
To assess perceived burden among people caring for others with disabilities. There are 22 items in which the carer rates perceived burden from 0 (never) to 4 (nearly always).
A total score of 0 to 20 = little or no burden; 21 to 40 = mild to moderate burden; 41 to 60 = moderate to severe burden; 61 to 88 = severe burden.
To assess usability of devices and applications. Participants are asked to score the following 10 items with one of five responses that range from Strongly Agree to Strongly disagree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Stephanie Rossit, Ph.D | +44 (0)160359 1674 | s.rossit@uea.ac.uk | |
Contact: Valerie Pomeroy, Ph.D | +44 (0)1603 59 1668 | v.pomeroy@uea.ac.uk |
United Kingdom | |
University of East Anglia | Recruiting |
Norwich, Norfolk, United Kingdom, NR4 7TJ | |
Contact: Stephanie Rossit, PhD | |
Principal Investigator: Stephanie Rossit | |
Sub-Investigator: Valerie Pomeroy | |
Sub-Investigator: Amy Jolly | |
Sub-Investigator: Helen Morse |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 20, 2019 | ||||||||
First Posted Date ICMJE | May 28, 2019 | ||||||||
Last Update Posted Date | August 12, 2019 | ||||||||
Actual Study Start Date ICMJE | May 6, 2019 | ||||||||
Estimated Primary Completion Date | February 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Behavioral Inattention Test (BIT) conventional sub tests [ Time Frame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2) ] Standardized measure of spatial inattention
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||||||
Brief Title ICMJE | Investigating Usability of c-SIGHT in the Homes of Brain Injury Survivors | ||||||||
Official Title ICMJE | Investigating a Portable Patient-led Virtual Reality Platform for Assessment and Rehabilitation of Hemispatial Neglect: a Usability Study | ||||||||
Brief Summary | A brain injury can damage the brain, so that it no longer receives information about the space around one side of the world. If this happens, people may not be aware of anything on one side, usually the same side they also lost their movement (the most affected side). This severe condition is called spatial neglect. Currently there is no recommended diagnostic test or clinically-proven treatment for the condition. In a recent study, the investigators found a long-lasting reduction in neglect if people practiced picking-up an object with their unaffected hand. This intervention is called Spatial Inattention Grasping Home-based Therapy (SIGHT). It requires people to lift wooden rods of different lengths. Once a person is familiar with the task, they can practice on their own at a time convenient to them in their homes. The investigators have developed the first computerized version of SIGHT (c-SIGHT) as well as a novel diagnostic test for neglect using portable low-cost motion-tracking technology that can be used in the patient's home. In the proposed study, the investigators will investigate how usable and acceptable this technology is in people's homes. Stroke survivors (recruited from community settings) will undergo a 7-day self-led training at their homes with c-SIGHT. At the end of the intervention, 1:1 semi-structured interviews will be carried out with both stroke survivors and carers to investigate usability and acceptability of c-SIGHT. Moreover, spatial neglect, carer burden and motor function will be assessed pre- and post-completion of c-SIGHT. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: c-SIGHT (computorized spatial innatention grasping home-based therapy)
C-SIGHT will be self-administered at people's homes. c-SIGHT is a computerized therapy administered via people's television. The therapy involves performing repeated rod lifts with the less impaired arm in response to auditory and visual instructions presented on the television screen connected to a laptop. A small motion-tracking camera monitors rod lifts during therapy sessions. People will be asked to self-administer c-SIGHT for 1 hour a day (30min after breakfast and 30min after lunch) for 7 consecutive days. The first day of therapy will be performed with a therapist there for training purposes.
Other Name: visuomotor feedback training
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Study Arms ICMJE | Experimental: c-SIGHT
SIGHT requires participants to grasp and lift rods with their less impaired arm.
Intervention: Behavioral: c-SIGHT (computorized spatial innatention grasping home-based therapy)
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Publications * | Rossit S, Benwell CSY, Szymanek L, Learmonth G, McKernan-Ward L, Corrigan E, Muir K, Reeves I, Duncan G, Birschel P, Roberts M, Livingstone K, Jackson H, Castle P, Harvey M. Efficacy of home-based visuomotor feedback training in stroke patients with chronic hemispatial neglect. Neuropsychol Rehabil. 2019 Mar;29(2):251-272. doi: 10.1080/09602011.2016.1273119. Epub 2017 Jan 24. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
10 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 3, 2020 | ||||||||
Estimated Primary Completion Date | February 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United Kingdom | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03963661 | ||||||||
Other Study ID Numbers ICMJE | R206721 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Stephanie Rossit, University of East Anglia | ||||||||
Study Sponsor ICMJE | University of East Anglia | ||||||||
Collaborators ICMJE | National Institute for Health Research, United Kingdom | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | University of East Anglia | ||||||||
Verification Date | August 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |