Control of Unsupported Paraplegic Standing

Stroke Clinical Trial

Official title:

Integrated Voluntary Control of Unsupported Paraplegic Standing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00204113
• Other study ID #: GUStandingSCI
• Secondary ID: UK EPSRC: GR/R79
• Status: Active, not recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: June 10, 2008
• Start date: June 2002

Study information

• Verified date: June 2008
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Incomplete SCI

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Stroke

Intervention

Device:
• Multi-purpose rehabilitation frame

• Surface Functional Electrical Stimulation

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth National Spinal Injuries Unit	Glasgow	Lanarkshire
United Kingdom	University of Glasgow	Glasgow	Lanarkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimates of physical parameters (ie. stiffness, viscosity, inertia)
Secondary	quality of standing
Secondary	amount of sway
Secondary	timing of standing