Specialty: Stroke, Primary sub-specialty: Rehabilitation
Conditions
Interventions
People with stroke (PwS)
PwS will be recruited at one of the three clinical sites. Each participant will take part in up to eight sessions, lasting approximately one hour over a period of up to six w
Sponsors
University of Salford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Therapist participants inclusion criteria: 1. Practicing therapist working with stroke patients 2. Successfully completed the training to use FES-UPP Person with stroke participant inclusion criteria: 1. Aged 18 or over 2. Evidence of a clinical stroke, as defined by the WHO “ rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin” 3. Impairment of one or both upper limbs, for which they are, or plan to be, participating in therapy 4. Medically fit to engage in active therapy sessions 5. Less than 6 months post-stroke 6. Sufficient level of cognition and communication to comply with the assessments and participate in the study. This will be assessed in the informed consent process, either involving the person with stroke themselves, or declaration of personal consultee where the consent trained professional, therapist and personal consultee are in agreement that it is appropriate for that person to take part in the study 7. Potential person with stroke (pws) participant expected to remain under the care of one of the services (See above for details on the three services) for sufficient time to allow at least 2 sessions with FES-UPP to be completed
Exclusion criteria
Exclusion criteria: Participant with stroke exclusion criteria: 1. Any neurological condition that effects voluntary control of upper limb movements, such as Myotonic Muscular Dystrophy, Polio, Multiple Sclerosis, unresolved peripheral nerve injuries 2. Complex regional pain syndrome 3. Orthopaedic conditions that restrict joint range 4. Severe Rheumatoid Arthritis 5. Epilepsy not adequately controlled by medication 6. Cardiac pacemaker or other active implanted device 7. Metal external fixator implant 8. Cancerous tissue/malignancy in the region of stimulation 9. Pregnancy 10. Skin rash, allergy, broken skin, wound or poor skin condition in an area where electrodes are to be placed 11. Requiring an interpreter Criteria to be discussed with the Research Team: 1. Painful shoulder, or pain in the upper limb 2. Participating in another study 3. Fixed flexion contracture or excessive spasticity in more than 2 muscles 4. Any medical condition other than those listed above that may affect the response to ES
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Upper limb function, is assessed with and without FES at a convenient time over the course of the planned therapy sessions (ideally sessions 2, 3 or 4). | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient outcomes: 1. Spasticity is measured using the Modified Ashworth Scale at week 1 2. Upper limb impairment is measured using the Fugl-Meyer UE Scale at week 1 3. Neglect is measured using the Star Cancellation Test at week 1 4. Cognitive ability is measured using the Montreal Cognitive Assessment at week 1 5. Therapy delivered is measured using the FES-UPP software at all sessions 6. User perception of the system is measured using the Patient Participant Questionnaire at week 6 (or earlier, if completed 8 sessions before 6 weeks, or exit study for other reason) Therapist outcomes: 1. Therapist characteristics are measured using the therapist profiling questionnaire at baseline 2. Views on the training is measured using the Training Questionnaire at baseline 3. Perceptions of the system is measured using the Technology Acceptance Model at the end of training and at the end of training and at the end of study baseline and 5 months 4. User perspective is measured using a semi-structured interview at 5 months | — |
Countries
United Kingdom
Contacts
Public ContactHelen Luckie
Outcome results
None listed