A clinical investigation of a novel functional electrical stimulation system

Completed

• Conditions: Specialty: Stroke, Primary sub-specialty: Rehabilitation; UKCRC code/ Disease: Stroke/ Cerebrovascular diseases; Nervous System Diseases; Stroke

• Registration Number: ISRCTN59243785
• Lead Sponsor: niversity of Salford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-13
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pper 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).