ISRCTN59243785
Completed
Not Applicable
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 sites30 target enrollmentJanuary 13, 2017
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Specialty: Stroke, Primary sub-specialty: Rehabilitation
- Sponsor
- niversity of Salford
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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