Paraplegic Cycling: Improving Health After Spinal Cord Injury

NCT00204100 | Unknown

• 2 other identifiers: FEScyclingGlasgowUK EPSRC: GR/R92462/01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

paraplegia; spinal cord injury; functional electrical stimulation; cycling; exercise; cardiopulmonary fitness

Outcome Measures

Primary Outcomes (1)

• changes in cardiopulmonary fitness

Secondary Outcomes (7)

• changes in:

• bone mineral density

• muscle bulk

• peak muscle force

• soft tissue distribution

Interventions

Surface Functional Electrical Stimulation DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complete spinal cord lesion between T3-T12, of at least 1 year duration. Age between 18-65 years No significant medical or psychiatric complications (assessed by clinician). Sufficient range of motion at the joints (assessed by therapist). No excessive spasticity (assessed by therapist). Bone density in necks of femora and upper tibias \> 40 - 60 mg/cm3. Willing to attend the clinic and to exercise at home according to the training programme. Having space at home to set up the tricycle ergometer for frequent use.

You may not qualify if:

• Bone density in necks of femora and upper tibias \< 40 mg/cm3. Unable to transfer safely between wheelchair and tricycle.

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (2)

University of Glasgow

Glasgow, Lanarkshire, G12 8QQ, United Kingdom

Location

Queen Elizabeth National Spinal Injuries Unit

Glasgow, Lanarkshire, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Kenneth J Hunt, BSc, PhD, DSc

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2003
• Study Completion: May 1, 2005
• Last Updated: October 12, 2006

Record last verified: 2005-05

Locations

GB (2)