Clinical trial NCT04064385: Functional Electrical Stimulation Cycling in SCI
Official title: Functional Electrical Stimulation Cycling in Acute Spinal Cord Injury; a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injury, Acute
Paraplegia
Tetraplegia
Keywords: Functional Electrical Stimulation Cycling
Physical Therapy
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: NHS Greater Glasgow and Clyde
First posted: 2019-08-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spinal cord injury (SCI) is a devastating, life-altering injury; requiring tremendous changes in an individual's lifestyle. Cycling, provides an ideal way for individuals with SCI to exercise and address the long-term consequences of SCI by targeting the lower extremity muscles. Cycling with the addition of functional electrical stimulation (FES) allows persons with paralysis to exercise their paretic or paralysed leg muscles. The Queen Elizabeth National Spinal Injury Unit (QENSIU) in Glasgow offers FES cycling for people with spinal cord injuries, which combines functional electrical stimulation (FES) with a motorised ergometer that allows repetitive cycling activity. It stimulates muscles with electrodes attached to the skin, producing muscle contractions and patterned activity. So far no previous randomised control trials on FES cycling in the acute SCI population have reported changes in ability to undertake activities of daily living or the trunk balance.

Detailed description: Up to 12 participants admitted to the QENSIU will be recruited to the study. They will be randomised to the intervention (n=8) or control group (n=4). The intervention group will receive 6 weeks FES cycling training in addition to usual care; the control group will receive usual care only. Outcome measures: Spinal Cord Injury Functional Ambulation Inventory, The Spinal Cord Independence Measure, ASIA Impairment Scale, Handheld dynamometry, 10-Metre Walking Test, Timed Up and Go Test, Trunk Impairment Scale, Modified Ashworth scale, Modified Tardieu Scale, the Patients Global Impression of Change.

Eligibility criteria: Inclusion Criteria:

* identified as being medically stable by the treating consultant,
* within the first 6 weeks post-injury,
* able to sit for 2 hours in a wheelchair,
* over 18 years old,
* acquired non progressive SCI - traumatic, spinal cord stroke, surgical injury,
* an incomplete SCI, graded as American Spinal Injury Association (ASIA) B (motor complete, sensation present below the lesion); C (some but not useful motor function) or D (useful motor function present),

Exclusion Criteria:

* acute condition impairing participant's ability to cycle (eg, leg fracture),
* proven or suspected neuromuscular weakness affecting the legs due to another condition (eg, stroke or Guillain-Barré syndrome),
* unable to follow instruction in English
* symptomatic cardiac disease,
* ventilator dependency,
* severe spasticity,
* uncontrolled autonomic dysreflexia,
* possible, suspected or confirmed pregnancy,
* likely to be discharged before the end of the exercise intervention.
* unable to tolerate the sensation of FES

Primary outcomes:
measure: Change in Spinal Cord Injury Functional Ambulation Inventory (SCI- FAI)
timeFrame: baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: The Spinal Cord Independence Measure (SCIM III)
timeFrame: baseline, 6 weeks, 12 weeks
measure: ASIA Impairment Scale
timeFrame: baseline, 6 weeks, 12 weeks
measure: Handheld dynamometry (HDD)
timeFrame: baseline, 6 weeks, 12 weeks
measure: 10-Metre Walking Test (10MWT)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Timed Up and Go (TUG) Test
timeFrame: baseline, 6 weeks, 12 weeks
measure: Trunk Impairment Scale (TIS)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Modified Ashworth scale (MAS)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Modified Tardieu Scale (MTS)
timeFrame: baseline, 6 weeks, 12 weeks
measure: the Patients Global Impression of Change
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: The Queen Elizabeth National Spinal Injuries Unit
Study officials:
affiliation: Glasgow Caledonian University
name: Aleksandra Dybus, PhD
role: PRINCIPAL_INVESTIGATOR
References: