Functional Electrical Stimulation Cycling in SCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury

NCT03834324

Spinal Cord Injuries

COMPLETED NA

Paraplegic Cycling: Improving Health After Spinal Cord Injury

NCT00204100

Spinal Cord Injury

UNKNOWN NA

Early FES Cycling in Acute Spinal Cord Injury for Neuromuscular Preservation and Neurorecovery

NCT05255679

Acute Spinal Cord Injury

COMPLETED NA

Non-invasive Brain Stimulation Paired With FES Cycling Post SCI

NCT05975606

Incomplete Spinal Cord Injury

RECRUITING NA

The Effects of Two Functional Electrical Stimulation Cycling Paradigms

NCT01244594

Spinal Cord Injury

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury, Acute Paraplegia Tetraplegia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

FES cycle training will be performed on the RT300 FES cycle ideally 3 times per week for 6 weeks, each session lasting up to 90 minutes. Electrical stimulation will be delivered through up to 12 independent channels each delivering up to 140 mA current on the following muscles (both on the right and left leg): quadriceps, femoral biceps and gluteus, gastrocnemius and tibialis anterior. Abdominal and back extensor muscles may also be stimulated if the participant presents with neurological trunk weakness (SCI above T6). The FES unit will stimulate the muscles that extend the hip (gluteals), flex the knee (hamstrings) and extend the knee (quadriceps) in the correct order to bring about a cycling motion. The feet and lower legs of the participants will be strapped into the pedals and the wheelchair will be coupled in a rigid manner with the training device.

Group Type EXPERIMENTAL

FES Cycling

Intervention Type DEVICE

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.

Control

Participants in the control group will receive usual care, consistent with standard NHS care in this population. Usual physiotherapy care is provided, up to 2 times per day, 4 to 5 days per week, each lasting approximately 90 minutes. Physiotherapists provide one to one function-oriented physiotherapy session to improve balance, muscle strength and transfer skills.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No