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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCI-FES hand therapy | Experimental | BCI-FES hand therapy sessions (set up and use of system) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCI-FES hand therapy | Procedure | BCI-FES rehabilitation therapy of the upper limb |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful training for operation of BCI-FES system | Number of times patients/caregivers successfully operate BCI-FES system within 30 min | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| System reliability | Number of times patients manage to activate the BCI-FES system | 2 months |
| Time taken to use system | Average time required to accomplish BCI-FES therapy (excluding setup time) |
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Inclusion Criteria:
Patients
Occupational therapists
Caregivers
Exclusion Criteria:
Patients
Occupational therapists
Caregivers
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| Name | Affiliation | Role |
|---|---|---|
| Aleksandra Vuckovic, BEng MSc PhD | University of Glasgow | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth National Spinal Injuries Unit | Glasgow | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33632262 | Derived | Zulauf-Czaja A, Al-Taleb MKH, Purcell M, Petric-Gray N, Cloughley J, Vuckovic A. On the way home: a BCI-FES hand therapy self-managed by sub-acute SCI participants and their caregivers: a usability study. J Neuroeng Rehabil. 2021 Feb 25;18(1):44. doi: 10.1186/s12984-021-00838-y. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 2 months |
| NASA task load index | Score from National Aeronautics and Space Administration (NASA) Task Load Index questionnaire | 2 months |
| Psychological Effect of Assistive Devices | Score of Psychological Effect of Assistive Devices questionnaire | 2 months |
| Quebec User Evaluation of Satisfaction with Assistive Technology | Score of Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire | 2 months |
| Grip strength | Change in grip strength | Baseline and 2 months |
| Hand range of motion | Change in hand range of motion | Baseline and 2 months |
| D014947 | Wounds and Injuries |