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Control of Unsupported Paraplegic Standing

Primary Purpose

Spinal Cord Injury, Stroke

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Multi-purpose rehabilitation frame
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 spinal cord injury, standing, balance, functional electrical stimulation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria: Neurologically intact, healthy individuals individuals with complete spinal cord lesion between T6 and T12 Exclusion Criteria: Incomplete SCI

Sites / Locations

  • University of Glasgow
  • Queen Elizabeth National Spinal Injuries Unit

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

quality of standing
amount of sway
timing of standing

Full Information

First Posted
September 12, 2005
Last Updated
June 10, 2008
Sponsor
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT00204113
Brief Title
Control of Unsupported Paraplegic Standing
Official Title
Integrated Voluntary Control of Unsupported Paraplegic Standing
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Glasgow

4. Oversight

5. Study Description

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.
Detailed Description
Aim: 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. Background: In spinal cord injury (SCI), the paralysed muscles generally retain their ability to contract and electrical stimulation can be used in rehabilitation as a therapy. With functional electrical stimulation (FES) the aim is to restore some normal motor functions such as standing, stepping or cycling. A number of studies have investigated the physiological effects and potential therapeutic benefits of lower-limb FES exercise. These studies have shown that the benefits include restoration of muscle bulk and strength, a reduction in the rate of bone demineralisation, improvements in the range of joint motion, and relaxation of spasm. Standing is an important part of rehabilitation therapy for paraplegic patients, and helps to alleviate some of the secondary effects of paralysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Stroke
Keywords
spinal cord injury, standing, balance, functional electrical stimulation

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Multi-purpose rehabilitation frame
Intervention Type
Device
Intervention Name(s)
Surface Functional Electrical Stimulation
Primary Outcome Measure Information:
Title
estimates of physical parameters (ie. stiffness, viscosity, inertia)
Secondary Outcome Measure Information:
Title
quality of standing
Title
amount of sway
Title
timing of standing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Eligibility Criteria
Inclusion Criteria: Neurologically intact, healthy individuals individuals with complete spinal cord lesion between T6 and T12 Exclusion Criteria: Incomplete SCI
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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Control of Unsupported Paraplegic Standing

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