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Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury

NCT03834324 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-10-08

No results posted yet for this study

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

Interventions

DEVICE

FES

Functional Electrical Stimulation during cycling with Virtual Reality Feedback

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • University of Southampton

    lead OTHER

Principal Investigators

  • Trudi Bartlett, BSc · University of Southampton

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-03
Primary Completion
2016-04-29
Completion
2018-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03834324 on ClinicalTrials.gov