NCT00204113

Brief Summary

The study will investigate the feasibility of using functional electrical stimulation (FES) of the calf muscles of paraplegic subjects to assist in posture stabilisation during standing. We aim to achieve postural stability by combining controlled FES of the lower-limb muscles with the voluntary motor control skills of the intact upper body.

Trial Health

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Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.3 years 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

June 13, 2008

Status Verified

June 1, 2008

First QC Date

September 12, 2005

Last Update Submit

June 10, 2008

Conditions

Spinal Cord InjuryStroke

Keywords

spinal cord injurystandingbalancefunctional electrical stimulation

Outcome Measures

Primary Outcomes (1)

  • estimates of physical parameters (ie. stiffness, viscosity, inertia)

Secondary Outcomes (3)

  • quality of standing

  • amount of sway

  • timing of standing

Interventions

Multi-purpose rehabilitation frameDEVICE
Surface Functional Electrical StimulationDEVICE

Eligibility Criteria

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

You may qualify if:

  • Neurologically intact, healthy individuals individuals with complete spinal cord lesion between T6 and T12

You may not qualify if:

  • Incomplete SCI

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

MeSH Terms

Conditions

Spinal Cord InjuriesStroke

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersBrain DiseasesVascular DiseasesCardiovascular Diseases

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

June 1, 2002

Last Updated

June 13, 2008

Record last verified: 2008-06

Locations

GB(2)