Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752982
Status:
UNKNOWN
Last Update Posted:
2021-07-12
First Post:
2021-02-07
Brief Title:
Can we Use c-SIGHT for Spatial Neglect in Stroke Survivors Homes
Sponsor:
University of East Anglia
Organization:
University of East Anglia
Study Overview
Official Title:
A Feasibility Study of a Computerised Spatial Inattention Grasping Home-based Therapy for Stroke Survivors c-SIGHT
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
c-SIGHT
Brief Summary:
Spatial neglect is a common post-stroke condition in which people may not be aware of anything on one side of the world usually the same side they lost their movement Currently there is no effective treatment for spatial neglect A therapy called SIGHT Spatial Inattention Grasping Home-based Therapy has shown early evidence of improving stroke survivors spatial neglect Rossit et al 2019 SIGHT involves individuals picking-up and balance wooden rods with their less affected hand independently without the need for a therapist present at all times Working with stroke survivors carers and clinicians we have developed of a computerized version of SIGHT c-SIGHT Morse et al in press The present trial aims to 1 investigate the feasibility of a blinded randomized controlled trial of c-SIGHT active intervention vs an attentional control training version of c-SIGHT sham intervention in the homes of stroke survivors with spatial neglect 2 Explore participants experience using c-SIGHT independently at home and 3 Explore the potential effects and effect size of c-SIGHT active intervention compared to the attentional control training to inform a future Phase II trial
Detailed Description:
This is a multi-centre two-arm blinded feasibility clinical trial with an embedded qualitative study Following baseline assessment participants will be randomized using minimization to either active vs sham version of computerised Spatial Inattention Grasping Home-based Therapy c-SIGHT Randomization and group allocation will be managed and run by Norwich Clinical Trials Unit independent from research team and outcome assessors Participants carers outcome assessors clinical care team and research team will be blinded to participant group allocation Participants allocated to the active intervention c-SIGHT group will be required to lift and balance three wooden rods of different lengths Those in the attentional control c-SIGHT group will use the same equipment but will be required to lift the rods from one end only and not attempt to balance them an attentional control During the first training session a therapist independent from the outcome assessors will set-up the equipment and train the participant to self-administer the relevant version of c-SIGHT independently ie without the presence of a therapist Following this training session participants will self-administer the training for 10 consecutive days thirty-minute sessions 2 times a day - Training phase On the last day of the training day 10 the therapist will return to participants homes to complete a monitoring visit and collect equipment To monitor adherence and therapy compliance the therapist will collect photos and videos of the first and last session of the training A blinded assessor will collect outcome assessments at the end of the training phase T1 and at one-month post-training T2 The post-training T1 data collection visit will also include one-to-one semi-structured interviews with stroke survivor participants and their carers qualitative study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SA PGF 19100016 | OTHER_GRANT | Stroke Association | None |