Paraplegic Cycling: Improving Health After Spinal Cord Injury

NCT00204100 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2006-10-12

No results posted yet for this study

Summary

Surface electrical stimulation has for many years been widely used to retrain paralysed muscle and achieve the functions of standing and stepping. Recently a number of centres have used electrical stimulation of the leg muscles to achieve cycling. During cycling the quadriceps and hamstring muscles (thigh muscles) (and sometimes also the gluteal (buttocks) muscles) are stimulated to obtain a cycling motion. Stimulation is applied using adhesive electrodes placed on the surface of the skin. This form of exercise is known as FES-cycling (FES = Functional Electrical Stimulation).

We have recently carried out a pilot study which investigated the feasibility of lower-limb cycling using electrical stimulation. Cycling is accomplished using a standard recumbent tricycle, which is adapted for the purpose of FES cycling. Three people with a complete spinal cord lesion at level T7-T10 took part in the pilot study. The subjects are now able to cycle continuously and reliably on a tricycle mounted on a cycle trainer for periods of up to 1 hour. The subjects are also able to cycle outside for distances of up to 3 km.

The purpose of the new study is threefold: (i) We wish to develop the equipment and methods for recreational cycling to the stage of a pre-commercial design specification; (ii) The subjects recruited for the project will carry out a progressive, high-intensity cycle-training programme. In Glasgow, 5 paraplegic subjects shall complete the training programme, which will be based at their homes. This will allow us to fully assess the feasibility of recreational FES-cycling, by measuring the power which can be sustained during long periods of cycling, and to measure the impact of the training regime on their quality of life; (iii) We will determine whether the training regime leads to significant improvements in cardiopulmonary fitness, and therefore lower risk of heart disease, and to reductions in the likelihood of the development of pressure sores and fractures.

We hope that this type of exercise will lead to general improvements in the fitness of people who might use the system in future.

Conditions

  • Spinal Cord Injury

Interventions

DEVICE

Surface Functional Electrical Stimulation

Sponsors & Collaborators

  • University of Glasgow

    lead OTHER

Principal Investigators

  • Kenneth J Hunt, BSc, PhD, DSc · University of Glasgow

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Completion
2005-05-31

Countries

  • United Kingdom

Study Locations

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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 NCT00204100 on ClinicalTrials.gov