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Paraplegic Cycling: Improving Health After Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Surface Functional Electrical Stimulation
Sponsored by
University of Glasgow
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring paraplegia, spinal cord injury, functional electrical stimulation, cycling, exercise, cardiopulmonary fitness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: 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. Exclusion Criteria: Bone density in necks of femora and upper tibias < 40 mg/cm3. Unable to transfer safely between wheelchair and tricycle.

Sites / Locations

  • University of Glasgow
  • Queen Elizabeth National Spinal Injuries Unit

Outcomes

Primary Outcome Measures

changes in cardiopulmonary fitness

Secondary Outcome Measures

changes in:
bone mineral density
muscle bulk
peak muscle force
soft tissue distribution
seating pressure
re-oxygenation after ischaemia

Full Information

First Posted
September 12, 2005
Last Updated
October 11, 2006
Sponsor
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT00204100
Brief Title
Paraplegic Cycling: Improving Health After Spinal Cord Injury
Official Title
The Development of Systems for Paraplegic Cycling: Improving Health After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Glasgow

4. Oversight

5. Study Description

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.
Detailed Description
Background: Spinal cord injury (SCI) prevents normal leg exercise which leads to secondary complications, including cardiopulmonary deconditioning, a high incidence of pressure sores, and bone demineralisation. Wheelchair sports do not raise fitness to the level of sedentary non-injured people but it has been shown that cycling via functional electrical stimulation, "FES-cycling", can. Previous studies have been clinic-based; this limits the exercise time and is inappropriate for widespread use. We propose to show that home-based FES-tricycling can be a recreation, and can also lead to significant health benefits. We will train subjects at home more intensively than in previous studies, to see whether they can cycle useful distances. The effects of this training will be systematically assessed in a Health Study, which will: (i) regularly monitor cardiopulmonary fitness; (ii) make regular tissue measurements related to pressure sore susceptibility, and (iii) measure the effect on bone density. These health measurements will be made at the collaborating clinical centres, i.e. for Glasgow, this will be at the Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital. We will also document the mobile recumbent tricycle system as a design specification, in preparation for commercialisation. The project will be based around three centres, in London, Glasgow and Nottwil, and brings together an interdisciplinary team of engineers, exercise scientists, therapists and clinicians. Aims: Engineering Development. To develop the equipment and methods for recreational cycling to the stage of a pre-commercial design specification. Training for Recreation. To carry out a progressive, high-intensity FES cycle-training programme. 15 paraplegic subjects (5 at each centre) shall complete the training programme, which is based at their homes. To 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. Health and Fitness Study. To assess 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
paraplegia, spinal cord injury, functional electrical stimulation, cycling, exercise, cardiopulmonary fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Surface Functional Electrical Stimulation
Primary Outcome Measure Information:
Title
changes in cardiopulmonary fitness
Secondary Outcome Measure Information:
Title
changes in:
Title
bone mineral density
Title
muscle bulk
Title
peak muscle force
Title
soft tissue distribution
Title
seating pressure
Title
re-oxygenation after ischaemia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Bone density in necks of femora and upper tibias < 40 mg/cm3. Unable to transfer safely between wheelchair and tricycle.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth J Hunt, BSc, PhD, DSc
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Glasgow
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 8QQ
Country
United Kingdom
Facility Name
Queen Elizabeth National Spinal Injuries Unit
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G51 4TF
Country
United Kingdom

12. IPD Sharing Statement

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Paraplegic Cycling: Improving Health After Spinal Cord Injury

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