Status:
COMPLETED
Patient Self-managed BCI-FES
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
University of Glasgow
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study aims to assess the feasibility of therapist-caregiver-patient training to use BCI and FES technology with a view to the inexpensive equipment eventually being used for home use by tetrapleg...
Detailed Description
Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body. People with injury around the neck, suffer from tetraplegia, which affects function of both upper and lower ...
Eligibility Criteria
Inclusion
- Patients
- being within a year post-injury
- has a caregiver willing to commit their time to the study
- normal or corrected to normal vision
- no history of brain disease or injury
- incomplete injury at level C2 to C7
- minimum computer literacy
- understands spoken and written English
- Occupational therapists
- already has experience in providing occupational therapy to spinal cord injured people
- familiar with using FES on patients
- Caregivers
- able and willing to commit time to the study
- minimum computer literacy
- possess mobile phone with a camera or are allowed to use patient's mobile phone with a camera for taking photos of the experimental setup (to remind themselves)
- understands spoken and written English
Exclusion
- Patients
- presence of neurological problem which may distort brain signal recording (e.g. epilepsy, Parkinson's disease, multiple sclerosis)
- presence of cognitive impairments which would prevent patients or caregivers from understanding the task
- inability to sit for 2 hours
- general poor health due to secondary consequences of injury
- any condition that would be contraindicative of using FES (pacemakers, sensitive skin/sores over areas where electrodes should be applied, pregnancy)
- Occupational therapists
- unable to commit sufficient time to the study
- cannot learn to setup BCI-FES within 30 min within 4 hourly training sessions
- Caregivers
- cannot be present for all five therapy sessions
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03257982
Start Date
January 25 2018
End Date
March 14 2019
Last Update
January 19 2021
Active Locations (1)
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1
Queen Elizabeth National Spinal Injuries Unit
Glasgow, United Kingdom