A clinical investigation of a novel functional electrical stimulation system (FES-UPP) for early post-stroke upper limb rehabilitation in 3 clinical settings

niversity of Salford0 个研究点目标入组 30 人开始时间: 2017年1月13日最近更新: 2017年2月6日

适应症

试验速览

暂无简介。

•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

•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

发起方

niversity of Salford