NCT00204126

Brief Summary

Treadmill therapy has the potential to improve the physical fitness and voluntary function of incomplete-lesion spinal cord injured (SCI) patients. However, if it is to be offered as a rehabilitation strategy, evidence must be gathered to support its effectiveness. Present methods used to determine the efficacy of treadmill training do not provide accurate means of monitoring changes in physical fitness during the exercise, or to accurately measure the changes in voluntary muscle function which may occur during a training intervention. We are therefore currently recruiting subjects for a study investigating the feasibility of new methods for monitoring improvements in physical fitness during walking on a treadmill. We also aim to develop methods for monitoring changes in voluntary muscle strength. The bone density of both legs will also be measured to determine if any improvement has occurred following training.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 11, 2006

Status Verified

September 1, 2006

First QC Date

September 12, 2005

Last Update Submit

September 8, 2006

Conditions

Spinal Cord Injury

Keywords

exercise testingtreadmillincomplete spinal cord injurynovel methods

Outcome Measures

Primary Outcomes (3)

  • peak oxygen uptake

  • lactate threshold

  • oxygen uptake kinetics

Secondary Outcomes (3)

  • torque during maximum voluntary contractions in leg muscles

  • central activation ratio of leg muscles

  • bone mineral density in tibia and femur

Interventions

Treadmill with partial body weight supportDEVICE
Surface Functional Electrical StimulationDEVICE

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Satisfactory general medical examination
  • Incomplete paraplegia or tetraplegia secondary to spinal cord lesion
  • Previously discharged from hospital, following primary rehabilitation
  • Capable of independent ambulation, with or without orthotic support

You may not qualify if:

  • Female subjects should not be pregnant.
  • No significant history of autonomic dysreflexia.
  • No history of significant osteoporosis, or associated previous history of spontaneous lower-limb fracture. Bone density will be measured in the epiphyses of the tibia and femur of both legs using peripheral Quantitative Computed Tomography (pQCT).
  • No history of coronary heart disease.
  • No clinical features of significant cardio-respiratory impairment.
  • Absence of hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Related Publications (2)

  • Granat M, Keating JF, Smith AC, Delargy M, Andrews BJ. The use of functional electrical stimulation to assist gait in patients with incomplete spinal cord injury. Disabil Rehabil. 1992 Apr-Jun;14(2):93-7. doi: 10.3109/09638289209167078.

    PMID: 1600188BACKGROUND

  • Porszasz J, Casaburi R, Somfay A, Woodhouse LJ, Whipp BJ. A treadmill ramp protocol using simultaneous changes in speed and grade. Med Sci Sports Exerc. 2003 Sep;35(9):1596-603. doi: 10.1249/01.MSS.0000084593.56786.DA.

    PMID: 12972882BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

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
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

February 1, 2005

Study Completion

February 1, 2005

Last Updated

September 11, 2006

Record last verified: 2006-09

Locations

GB(2)