Control of Unsupported Paraplegic Standing

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Glasgow.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Glasgow
ClinicalTrials.gov Identifier:
NCT00204113
First received: September 12, 2005
Last updated: June 10, 2008
Last verified: June 2008
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Voluntary Control of Unsupported Paraplegic Standing

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
Queen Elizabeth National Spinal Injuries Unit
Glasgow, Lanarkshire, United Kingdom, G51 4TF
University of Glasgow
Glasgow, Lanarkshire, United Kingdom, G12 8QQ
Sponsors and Collaborators
University of Glasgow
Investigators
Principal Investigator: Kenneth J Hunt, BSc, PhD, DSc University of Glasgow
  More Information

No publications provided

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

Keywords provided by University of Glasgow:
spinal cord injury
standing
balance
functional electrical stimulation

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014