Surface Functional Electrical Stimulation and Multi-purpose rehabilitation frame in Stroke and Spinal Cord Injury - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Incomplete SCI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
quality of standing
amount of sway
timing of standing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria