Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury

NCT03834324 | Completed

• 1 other identifier: 6054
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

Neuroscience research that has identified potential for recovery (neuroplasticity) following incomplete SCI has changed clinical practice away from compensation strategies towards optimizing recovery. Important factors include: repetitive exercise, Functional Electrical Stimulation (FES) and appropriate feedback. The iCycle combines repetitive exercise with FES and provides feedback on performance in a virtual cycle race. Unlike previous devices, performance in the race is determined only by voluntary effort (i.e. not torque generated by FES plus voluntary effort). In this study with incomplete SCI participants we will test the iCycle with six inpatients to refine the protocol and make technical improvements. We will then conduct an ABA pilot study (n=10) in which a 3G-connected iCycle is used in people's own homes. We will compare usual care (A) with iCycle exercise (B). Changes in neural connectivity (TMS evoked EMG potentials), muscle strength and walking will be measured as well qualitative analysis of users' views.

Conditions

Spinal Cord Injuries

Keywords

Functional Electrical Stimulation; Cycling; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).

  Neurological Classification

  Change between baseline and 4 weeks

• International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).

  Neurological Classification

  Change between baseline and 8 weeks

Secondary Outcomes (8)

• Oxford scale motor power grading

  Change between baseline and 4 weeks

• Oxford scale motor power grading

  Change between baseline and 8 weeks

• Modified Ashworth Score (MAS)

  Change between baseline and 4 weeks

• Modified Ashworth Score (MAS)

  Change between baseline and 8 weeks

• Spinal Cord Independence Measure (SCIM)

  Change between baseline and 4 weeks

Study Arms (1)

intervention

EXPERIMENTAL

FES

Device: FES

Interventions

FES DEVICE

Functional Electrical Stimulation during cycling with Virtual Reality Feedback

intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. using a wheelchair for at least two hours per day

You may not qualify if:

• cardiac pacemaker
• pressure sores or unresolved skin problems
• unhealed lower limb fractures
• pregnancy
• active heterotrophic ossification (lower limbs)
• severe osteoporosis
• complex regional pain syndrome
• metal implants near electrode sites
• lower limb malignancy
• T6 and below spinal malignancy
• uncontrolled autonomic dysreflexia
• history of knee dislocation/subluxation
• allergy to electrodes
• cognitive difficulties
• severe spasticity (Ashworth scale 4 or 5 in muscle groups that would prevent smooth pedalling) or

Sponsors & Collaborators

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

Related Publications (1)

• Duffell LD, Paddison S, Alahmary AF, Donaldson N, Burridge J. The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study. J Neuroeng Rehabil. 2019 Nov 27;16(1):149. doi: 10.1186/s12984-019-0619-4.

  PMID: 31771600 RESULT

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 Officials

• Trudi Bartlett, BSc

  University of Southampton

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Restorative Neuroscience

Model Details: Technology development and Observational study

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 7, 2019
• Study Start: May 3, 2013
• Primary Completion: April 29, 2016
• Study Completion: March 1, 2018
• Last Updated: October 8, 2021

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share