Queen Elizabeth National Spinal Injuries Unit
Glasgow, United Kingdom
NCT Number: NCT03257982
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 tetraplegic patients as a continuing rehabilitation method for sub-acute patients discharged from hospital.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Glasgow, United Kingdom
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 limbs. Although these patients often have a caregiver, their main priority is to regain some upper limb function to increase independence. About half of patients with tetraplegia have an incomplete injury, i.e. have some sensation and control of muscles preserved. Natural recovery takes about a year and is typically accompanied by intense physical therapy while patients are in a hospital. Patients spend on average 4 months in hospital and, once they go home, there are very limited options for further therapy, in particular those living in rural areas.
This study will test the feasibility of patient and caregiver self-managed hand therapy based on the combination of brain computer interface (BCI) and functional electrical stimulation (FES). BCI is a system which consists of an electroencephalographic device (EEG), a computer and software that can analyse EEG while it is being recorded. To ensure that the knowledge stays within hospital, occupational therapists will first be trained who will then train patients and caregivers. The BCI-FES therapy is based on a previous clinical study with hospitalised patients, in which a researcher administered the therapy. In this study, a portable BCI-FES system will be used with an inexpensive consumer BCI, which is designed for non-professionals. The primary objective is to assess whether it is feasible for caregivers and patients to learn to operate the portable BCI-FES system on their own within 5 training sessions. The secondary objectives are to collect feedback from patients and therapists of their views via semi-structured interviews and questionnaires; to assess how stable the system parameters (EEG parameters, electrode location, FES stimulation parameters)are over time; to assess whether there is any functional and neurological recovery.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients
Occupational therapists
Caregivers
Exclusion criteria
Patients
Occupational therapists
Caregivers
BCI-FES rehabilitation therapy of the upper limb
Time frame: 2 months
Number of times patients/caregivers successfully operate BCI-FES system within 30 min
Time frame: 2 months
Number of times patients manage to activate the BCI-FES system
Time frame: 2 months
Average time required to accomplish BCI-FES therapy (excluding setup time)
Time frame: 2 months
Score from National Aeronautics and Space Administration (NASA) Task Load Index questionnaire
Time frame: 2 months
Score of Psychological Effect of Assistive Devices questionnaire
Time frame: 2 months
Score of Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire
Time frame: Baseline and 2 months
Change in grip strength
Time frame: Baseline and 2 months
Change in hand range of motion
NHS Greater Glasgow and Clyde
Other
A Feasibility Study of Patient Self-Managed Brain-computer Interface Functional Electrical Stimulation (BCI-FES) Hand Therapy for Spinal Cord Injured Patients
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