Functional Electrical Stimulation Cycling in SCI

Tetraplegia Clinical Trial

Official title:

Functional Electrical Stimulation Cycling in Acute Spinal Cord Injury; a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04064385
• Other study ID #: GN19NE123
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: July 2020

Study information

• Verified date: August 2019
• Source: Glasgow Caledonian University
• Contact: Aleksandra Dybus, PhD
• Phone: 01412327888
• Email: aleksandra.dybus[@]gcu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Paraplegia
• Quadriplegia
• Spinal Cord Injuries
• Spinal Cord Injury, Acute
• Tetraplegia

Intervention

Device:
• FES Cycling
Stimulation parameters will be 450µs, 40Hz, and up to 140mA, these values will be changed if needed based on individual response. For example, stimulation to the gluteal muscles often may to be decreased to prevent autonomic dysreflexia. To receive correct stimulation parameters, stimulation intensity will be chosen to ensure a palpable muscle contraction and sensor tolerance. Each session will include a 2-minute warm-up and 2-minute cool-down of passive cycling. The unit automatically delivers enough stimulation to maintain a speed of 30 rotations per minute (rpm). Where this is not achieved, the leg cycle will assist the stimulated movement to maintain a speed of 30 rpm.

Locations

Country	Name	City	State
United Kingdom	The Queen Elizabeth National Spinal Injuries Unit	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
Glasgow Caledonian University	NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Spinal Cord Injury Functional Ambulation Inventory (SCI- FAI)	It consists of three components: gait parameter, assistive device use and walking ability. The gait parameter component is scored out of 20, 10 points for each of the right and left sides. The assistive device component is scored out of 14 (7 points for each side), and assesses upper and lower extremities in addition to the left and right limbs. Scores within each component are summed. Component scores range from 0 to 20 in the gait parameter component, 0 to 14 in the assistive device component, and 0 to 5 in the walking mobility component. The SCI-FAI is a reliable, valid and sensitive measure of walking ability in individuals with spinal cord injury.	baseline, 6 weeks, 12 weeks
Secondary	The Spinal Cord Independence Measure (SCIM III)	composed of 19 items that assesses 3 domains: self-care, respiration and sphincter management and mobility. The total SCIM scores range from 0 to 100.	baseline, 6 weeks, 12 weeks
Secondary	ASIA Impairment Scale	The ASIA impairment scale classifies motor and sensory impairment that results from a spinal cord injury. It divides spinal cord injuries into 5 categories: A-E. A- Complete - No motor or sensory function in the lowest sacral segment (S4-S5). B- Incomplete - Sensory function below neurologic level and in S4-S5, no motor function below neurologic level. C- Incomplete - Motor function is preserved below neurologic level and more than half of the key muscle groups below neurologic level have a muscle grade less than 3. D- Incomplete - Motor function is preserved below neurologic level and at least half of the key muscle groups below the neurologic level have a muscle grade >3. E- Normal - Sensory and motor function is normal	baseline, 6 weeks, 12 weeks
Secondary	Handheld dynamometry (HDD)	will be used to quantify the strength of the knee extensors, knee flexors, hip flexors, hip abductors, and ankle plantar flexors of both legs. The order of testing will be constant across testing sessions and position of patient and assessor standardised. Three trials will be performed on each muscle group. Prevention of muscle fatigue will be achieved by a 30-second recovery period after each trial and 2 minutes of rest between evaluations of the muscle groups. One or 2 trials will be used to familiarize the participants with the testing procedures before the actual strength measurements of each muscle group.	baseline, 6 weeks, 12 weeks
Secondary	10-Metre Walking Test (10MWT)	The total marked distance will be 14 meters and, to allow for acceleration and deceleration, participants will be timed over the middle 10 meters. Participants will walk the distance twice and the average of 2 trials will be measured. They will be asked to walk the distance as fast and safely as possible. The participant should perform this test with their assistive devices as appropriate.	baseline, 6 weeks, 12 weeks
Secondary	Timed Up and Go (TUG) Test	assesses mobility, balance, walking ability and falls risk. It measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down.	baseline, 6 weeks, 12 weeks
Secondary	Trunk Impairment Scale (TIS)	is a 17-item measure for assessing the level of motor impairment of the trunk e.g. coordination and sitting balance (static and dynamic). The scores range from 0 to 23 with lower scores indicating high levels of motor deficit in the trunk	baseline, 6 weeks, 12 weeks
Secondary	Modified Ashworth scale (MAS)	is a scale used to measure the level of spasticity in people with neurological conditions (ASHWORTH 1964). The MAS scores range from 0 to 4, with higher scores indicating an increase in muscle tone.; 0 No increase in muscle tone.; 1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension.; 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM.; 2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved.; 3 Considerable increase in muscle tone, passive movement difficult. 4 Affected part(s) rigid in flexion or extension	baseline, 6 weeks, 12 weeks
Secondary	Modified Tardieu Scale (MTS)	the MTS is a valid, reliable scale for measure the level of spasticity in patient with neurological conditions (Li, Wu, and Xiong 2014). Akpinar et al. (Akpinar et al. 2017) suggests its utility as a complementary tool when assessing spasticity in SCI patients. The MTS assesses the response of the muscle to different velocities of stretch in terms of quality and angle of the muscle tested. In terms of quality of muscle reaction, the score ranges from 0 to 5, where a score of 0 means that the muscle is not spastic while a score of 5 means that the muscle is spastic and immobile. In terms of angle of muscle reaction, the score is R1 or R2, where R1 means the joint demonstrates limited passive range of motion while R2 means the joint demonstrate full passive range of motion.	baseline, 6 weeks, 12 weeks
Secondary	the Patients Global Impression of Change	PGIC is a 7-point, patient reported scale which evaluates all aspects of the patients' health and assesses if there has been an improvement or decline in clinical status. Patients rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse" or "very much worse"	12 weeks