Functional Electrical Stimulation During Cycling in Peopl... | NCT03834324

Studies
Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury

NCT03834324

Sponsor

University of Southampton

Status

Completed

Last Update Posted

Oct 8, 2021Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Spinal Cord Injuries

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 3, 2013Actual

Primary Completion Date

Apr 29, 2016Actual

Completion Date

Mar 1, 2018Actual

First Submitted Date

Feb 5, 2019

First Submission Date that Met QC Criteria

Feb 6, 2019

First Posted Date

Feb 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2021

Last Update Posted Date

Oct 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jane Burridge, PhD, Professor of Restorative Neuroscience, University of SouthamptonPrincipal Investigator

Lead Sponsor

University of SouthamptonOTHER

Collaborators

Name	Class
University College, London	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Background: Functional Electrical Stimulation (FES) cycling can benefit health and may lead to neuroplastic changes following incomplete spinal cord injury (SCI). Our hypothesis is that greater neuroplastic effects occur when electrical stimulation of peripheral nerves is combined with voluntary drive. In this pilot study, we will investigate the effects of a one-month training programme using a novel device, the iCycle, in which voluntary effort (cortical drive) is encouraged by virtual reality biofeedback during FES cycling.

Methods: Eleven participants (C1-T12) with incomplete SCI (5 sub-acute; 6 chronic) will be recruited and undergo 12-sessions of iCycle training. Function will be assessed before and after training using the bilateral ISNC-SCI motor score neurological (motor) function, Oxford power grading, Modified Ashworth Score, Spinal Cord Independence Measure, the Walking Index for Spinal Cord Injury and 10m-walk test. Power output will be measured during training.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Experimental	FES	Device: FES

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FES	Device	Functional Electrical Stimulation during cycling with Virtual Reality Feedback	intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Oxford scale motor power grading	Muscle strength	Change between baseline and 4 weeks
Oxford scale motor power grading	Muscle strength

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. using a wheelchair for at least two hours per day

Exclusion Criteria:

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
neurological degenerative diseases.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Trudi Bartlett, BSc	University of Southampton	Study Chair

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31771600	Result	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.

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System