iCycle II: Recovery of Function Through FES Cycling With VR Biofeedback in People With SCI.

NCT04902482 | Recruiting

• 1 other identifier: 140131
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The annual incidence of traumatic spinal cord injury (SCI) is estimated at 2,500 (35 per week) in the UK and, due to advances in research and clinical management, the majority now have incomplete injuries, with significant potential for neurological improvement. Discovering ways to provide intensive, but cost-effective SCI rehabilitation is therefore increasingly important. The iCycle combines functional electrical stimulation (FES) cycling with VR cycle-racing feedback, where winning correlates with voluntary effort, to promote recovery. The aim is to improve walking in people with incomplete injuries, fundamental to independence and quality of life as well as long-term health. More intensive rehabilitative training is associated with better outcomes: the iCycle has the potential to increase intensity of exercise without additional demands on therapists' time and therefore cost. Following the encouraging results in an initial study; it is now important to find out whether recovery will continue at a similar rate if iCycle training continues beyond 4 weeks. Six volunteers with SCI will be recruited to participate in this 20 week, single-site open feasibility trial. The trial consists of an intervention phase lasting up to 12 weeks (3 iCycle sessions per week), and an 8-week follow-up phase. Outcome measures (ISNC-SCI motor scoring, Trunk Impairment scale, Walking Index for Spinal Cord Injury, 6-minute walk test, Goal Attainment Scale and TMS) will be taken every 4 weeks. The 12-week intervention phase will be separated into three 4-week blocks; at the end of each block participants may decide whether or not they wish to continue training.

Conditions

Spinal Cord Injuries

Keywords

Rehabilitation; FES cycling; Virtual Reality; Biofeedback; Motor Function

Outcome Measures

Primary Outcomes (1)

• Change in International Standards of Neurological Classification for SCI (ISNC-SCI) Motor score.

  This is a is a clinician-administered scale used to classify the severity (completeness) of injury in individuals with SCI.

  15 minutes

Secondary Outcomes (5)

• Change in Trunk Impairment Scale (TIS) score

  15 minutes

• Change in Walking Index for Spinal Cord Injury (WISCI II) score

  15 minutes

• change in 6-minute walk test (6MWT) distance

  15 minutes

• Threshold of evoked responses to Transcranial Magnetic Stimulation (TMS)

  60 minutes

• Audio/transcribed feedback from participants from semi-structured interview

  30 minutes

Study Arms (1)

iCycle training

EXPERIMENTAL

Participants will attend 3 training sessions per week at the RNOH. During these sessions, participants will tether their wheelchair (from under the seat) to the front of the iCycle, and their feet will be attached to the iCycle pedals. For training, participants will complete virtual reality cycle races displayed on a large screen in front of the iCycle: the more voluntary effort the participant contributes the greater the speed of the avatar. During cycling, a motor will control cycling speed, and muscle stimulation (FES) will be applied to the leg muscles (right and left gluteus, quadriceps and hamstrings) on alternative revolutions of the pedals. A dashboard screen will display controls for the stimulation, speed, brake, game switch and an emergency stop. Sessions will increase from 20 mins or the maximum achievable at the start (whichever is lower) up to at least 1 hour.

Device: iCycle Mark 3

Interventions

iCycle Mark 3 DEVICE

The iCycle Mark 3 is a cycle ergometer, designed to be used by people with SCI while they are seated in their own wheelchairs. The purpose of iCycle is to stimulate the leg muscles in the correct phase for cycling while motivating the person with a Virtual Reality cycling event, perhaps a race, to try to use their muscles.

iCycle training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years
• Incomplete SCI above T12
• \>12 months post injury
• Respond to FES
• No deteriorating condition or other co-morbidity that would make participation impractical or unsafe.
• Marginal walker defined as able to rise from a chair, stand for 10 seconds and walk \>10 steps without human help (but may use an aid including parallel bars).

You may not qualify if:

• Cardiac pacemaker
• Pressure sores/skin problems
• Unhealed lower limb fractures
• Pregnancy
• Active heterotrophic ossification - lower limbs
• Severe osteoporosis
• Complex regional pain syndrome
• Implanted metal work at electrode site (\< 3/12)
• Lower Limb Malignancy
• T6 and below spinal malignancy
• Uncontrolled autonomic dysreflexia
• History of knee dislocation/subluxation
• Allergy to electrodes
• Cognitive difficulties - must be able to demonstrate an understanding of the iCycle and the virtual reality cycling game
• Severe spasticity - Ashworth scale 4 or 5 in any lower limb muscle groups

Sponsors & Collaborators

• University College, London: lead
• University of Southampton: collaborator

Study Sites (1)

Royal National Orthopaedic Hospital

Stanmore, Middlesex, HA74LP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 26, 2021
• Study Start: January 6, 2022
• Primary Completion: July 31, 2024
• Study Completion: November 30, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)