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Completed

NCT Number: NCT00221078

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Neuroprosthesis

Device

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.

Other names: Functional Electrical Stimulation (FES)

Primary outcomes

  1. REL Hand Function Test

    Time frame: 45 min

  2. Fugl-Meyer Assessment

    Time frame: 30 min

Secondary outcomes

  1. Barthel Index

    Time frame: 25 min

  2. Functional Independence Measure

    Time frame: 25 min

  3. Chedoke-McMaster Stages of Motor Recovery

    Time frame: 30 min

Sponsors and collaborators

Lead sponsor

Toronto Rehabilitation Institute

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Feb 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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