Control of Unsupported Paraplegic Standing - Full Text View

Purpose

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.

Condition	Intervention
Spinal Cord Injury Stroke	Device: Multi-purpose rehabilitation frame Device: Surface Functional Electrical Stimulation

MedlinePlus related topics:

Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Integrated Voluntary Control of Unsupported Paraplegic Standing

Further study details as provided by University of Glasgow:

Primary Outcome Measures:

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

Secondary Outcome Measures:

quality of standing
amount of sway
timing of standing

Estimated Enrollment:	10
Study Start Date:	June 2002

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Incomplete SCI

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204113

Locations


United Kingdom, Lanarkshire
	University of Glasgow
	GLASGOW, Lanarkshire, United Kingdom, G12 8QQ
	Queen Elizabeth National Spinal Injuries Unit
	GLASGOW, Lanarkshire, United Kingdom, G51 4TF

Sponsors and Collaborators

University of Glasgow

Investigators


Principal Investigator:	Kenneth J Hunt, BSc, PhD, DSc	University of Glasgow

More Information

Centre for Rehabilitation Engineering, University of Glasgow This link exits the ClinicalTrials.gov site

Study ID Numbers:	GUStandingSCI, UK EPSRC: GR/R79234/01
First Received:	September 12, 2005
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00204113
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Glasgow:

spinal cord injury

standing

balance

functional electrical stimulation

Study placed in the following topic categories:

Spinal Cord Injuries

Spinal Cord Diseases

Cerebral Infarction

Stroke

Wounds and Injuries

Disorders of Environmental Origin

Central Nervous System Diseases

Trauma, Nervous System

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2008

Sponsored by:	University of Glasgow
Information provided by:	University of Glasgow
ClinicalTrials.gov Identifier:	NCT00204113