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StrokePhase 3NCT00221078

Benefits of Applying Neuroprosthesis for Improving Reaching and Grasping Functions in Stroke Patients

A Phase 3 study testing Neuroprosthesis in people with Stroke, run by Toronto Rehabilitation Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Functional electrical stimulation (FES) is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. By contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing. Read more about this study

Who is it for?
Any age
Conditions the study is for
Stroke
What is being tested?
Neuroprosthesis
Type of treatment
Medical device
How many people
40 participants
Where
1 siteCanada
Study dates
Apr 2003to Dec 2005
Phase
Phase 3
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient must be motivated to participate in the FES study, and must sign the letter of consent.
  • Patients must have hemiplegia and the stroke must be confirmed with a CT scan.
  • Patients must understand that the role of this study is to enhance recovery and not to guarantee it.

Who cannot join

  • Patients who is motivated and does not sign the letter of consent.
  • Patient who has serious cognitive or psychological impairments.
  • Patients who has skin rush, allergy or wounds.
  • Alcohol or drug abuse.
  • Edema in his/her upper extremity.
  • Patients with Shoulder Hand Syndrome
  • Global aphasia
  • Patients who shows early recovery of the function.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Toronto Rehabilitation Institute

    Toronto, Ontario, M5G 2A2

Other trials in Canada

About this study

Official title: Restoration of Reaching and Grasping Functions in Stroke Patients Using Functional Electrical Stimulation.

Functional electrical stimulation (FES) is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. By contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing. Final goal of the study is to evaluate if FES training when applied early during rehabilitation will help stroke patients to use their hands more effectively after discharge from a rehabilitation facility, compared to those patients who have not received FES training.

Read the detailed description

Neuroprosthesis are systems that apply functional electrical stimulation to cause muscle contractions. If the muscle contractions are sequenced properly one can generate various functions such as grasping, standing, and walking. Recent studies of others and our pilot study indicate that a neuroprosthesis can be successfully applied as a training device to help stroke patients who have hemiplegic arm to relearn how to reach and grasp various objects. The objective of this research program is to confirm these preliminary results with the broader population of stroke patients, and if successful to propose a method to introduce this rehabilitation treatment into Toronto Rehabilitation Institute, Stroke Unit as a primary intervention for hand function recovery. Specifically, our aim is to1)develop an exercise protocol that uses a neuroprosthesis for reaching and grasping developed by our team in combination with the standard physiotherapy treatments to enhance recovery of hemiplegic arm and hand; and 2) assess qualitatively and quantitatively improvements in the reaching and grasping functions achieved with standard rehabilitation treatment.

Conditions
Stroke
Being tested
Neuroprosthesis
Keywords
Cerebrovascular Accident, Stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeuroprosthesisDevice

    Also called Functional Electrical Stimulation (FES)

    The Compex Motion neuroprosthesis, developed by Drs.R. Popovic and Thierry Keller, and company Compex SA, is a flexible device designed to improve grasping function in both SCI and stroke patients. This multi-channel surface stimulation system for grasping provides both palmar and lateral grasp, and holds a number of advantages over the other existing neuroprostesis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. REL Hand Function Test

    Measured: 45 min

  2. Fugl-Meyer Assessment

    Measured: 30 min

Secondary outcomes (3)

  1. Barthel Index

    Measured: 25 min

  2. Functional Independence Measure

    Measured: 25 min

  3. Chedoke-McMaster Stages of Motor Recovery

    Measured: 30 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startApr 2003
  3. Primary completionJun 2005
  4. Study completionDec 2005

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00221078
Sponsor's protocol ID
88098-0461-RR001
Other IDs
88098-0461-RR001
Status last verified
Feb 2009
First submitted
14 Sep 2005
Last updated
5 Feb 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Popovic MR, Thrasher TA, Adams ME, Takes V, Zivanovic V, Tonack MI. Functional electrical therapy: retraining grasping in spinal cord injury. Spinal Cord. 2006 Mar;44(3):143-51. doi: 10.1038/sj.sc.3101822.

    PubMed 16130018

  • Marquez-Chin C, Bagher S, Zivanovic V, Popovic MR. Functional electrical stimulation therapy for severe hemiplegia: Randomized control trial revisited. Can J Occup Ther. 2017 Apr;84(2):87-97. doi: 10.1177/0008417416668370. Epub 2017 Jan 17.

    PubMed 28093928

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neuroprosthesis in people with Stroke, run by Toronto Rehabilitation Institute at 1 site in Canada.

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 3 inclusion and 8 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: finished, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

REL Hand Function Test (time frame: 45 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00221078, which also lists 2 linked publications.

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 5 Feb 2009.

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