Spinal Cord InjuryNCT00204113
Control of Unsupported Paraplegic Standing
A study testing Multi-purpose rehabilitation frame and Surface Functional Electrical Stimulation in people with Spinal Cord Injury and Stroke, run by University of Glasgow at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injury, Stroke
- What is being tested?
- Multi-purpose rehabilitation frame and Surface Functional Electrical Stimulation
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2002to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Neurologically intact, healthy individuals individuals with complete spinal cord lesion between T6 and T12
Who cannot join
- Incomplete SCI
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Glasgow
Glasgow, Lanarkshire, G12 8QQ
Queen Elizabeth National Spinal Injuries Unit
Glasgow, Lanarkshire, G51 4TF
About this study
Official title: Integrated Voluntary Control of Unsupported Paraplegic Standing
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.
Read the 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.
- Conditions
- Spinal Cord Injury, Stroke
- Being tested
- Multi-purpose rehabilitation frame, Surface Functional Electrical Stimulation
- Keywords
- spinal cord injury, standing, balance, functional electrical stimulation
- Medical subject headings
- Spinal Cord Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-purpose rehabilitation frameDevice
Surface Functional Electrical StimulationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
estimates of physical parameters (ie. stiffness, viscosity, inertia)
Secondary outcomes (3)
quality of standing
amount of sway
timing of standing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth J Hunt, BSc, PhD, DSc, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204113
- Sponsor's protocol ID
- GUStandingSCI
- Other IDs
- UK EPSRC: GR/R79234/01
- Status last verified
- Jun 2008
- First submitted
- 12 Sep 2005
- Last updated
- 13 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Voluntary Control of Unsupported Paraplegic Standing
- ClinicalTrials.gov ID
- NCT00204113
- Acronym / sponsor ID
- GUStandingSCI
- Conditions
- Spinal Cord Injury, Stroke
- Keywords
- spinal cord injury, standing, balance, functional electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Jun 2002
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Neurologically intact, healthy individuals individuals with complete spinal cord lesion between T6 and T12
Key exclusion criteria (1 listed)
- Incomplete SCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-purpose rehabilitation frame | Device | – |
| Surface Functional Electrical Stimulation | Device | – |
Primary outcome
estimates of physical parameters (ie. stiffness, viscosity, inertia)
3 secondary outcomes
quality of standing
amount of sway
timing of standing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth J Hunt, BSc, PhD, DSc principal investigator
University of Glasgow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-purpose rehabilitation frame and Surface Functional Electrical Stimulation in people with Spinal Cord Injury and Stroke, run by University of Glasgow at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimates of physical parameters (ie. stiffness, viscosity, inertia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2008.