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Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors

This study has been terminated.
(Lack of funding)
Sponsor:
Collaborators:
Wyss Institute at Harvard University
Center for Integration of Medicine & Innovative Technology
Information provided by (Responsible Party):
Yong-Tae Lee, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01689883
First received: September 10, 2012
Last updated: April 20, 2017
Last verified: April 2017
  Purpose
The overall objective of the study is to test whether the use of small electrical currents to stimulate proprioceptors of the upper limb has potential for improving robot-assisted upper-limb rehabilitation in stroke survivors.

Condition Intervention
Chronic Stroke Survivors Device: Current stimulator

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
The investigators will use a system to inject small currents in the arm while subjects perform upper-limb movements. Subjects will perform multiple trials. During half of the trials, subjects will receive actual stimulation. During the other half, subjects will receive sham stimulation.
Masking: No masking
Primary Purpose: Basic Science
Official Title: Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors

Resource links provided by NLM:


Further study details as provided by Yong-Tae Lee, Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Fugl-Meyer Assessment [ Time Frame: Changes in Fugl-Meyer Assessment score with vs without stimulation ]
    Subjects are asked to perform upper-limb movements from which a therapist can assess the severity of movement abnormalities (e.g. flexion synergies)


Secondary Outcome Measures:
  • Jebsen-Taylor Hand Function Test [ Time Frame: Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation ]
    Subjects are asked to perform a set of functional movements from which a therapist can assess subjects' functional limitations

  • Motor Activity Log [ Time Frame: Change in Motor Activity Log score with vs without stimulation ]
    Subjects are asked about the amount and quality of use of their stroke-affected arm during the performance of daily activities

  • Modified Ashworth Scale [ Time Frame: Change in Modified Ashworth Scale score with vs without stimulation ]
    A therapist examines subjects to assess the severity of spasticity

  • Box and Block test [ Time Frame: Change in Box and Block test score with vs without stimulation ]
    Subjects are asked to move as many small wooden blocks as possible from one to box to another in a set amount of time

  • Grip strength [ Time Frame: Change in grip strength with vs without stimulation ]
    A hand dynamometer is used to measure grip strength


Enrollment: 1
Actual Study Start Date: August 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Current stimulator
The investigators have developed a device to deliver very small currents to the arm. The device will be used while subjects perform upper-limb movements using a device for upper-limb rehabilitation. Subjects will perform multiple trials of movement. During half of the trials, they will receive actual stimulation. During the other half, they will receive sham stimulation.
Device: Current stimulator
This is a device developed by the investigators to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.

Detailed Description:

Study participants will be instructed to perform upper-limb movements using a system designed for upper-limb rehabilitation (Armeo Spring by Hocoma AG). The system provides subjects with unloading of the stroke-affected arm thus facilitating the performance of upper-limb movements. The system will be used to track the movements of the stroke-affected arm. Simultaneously, a custom-designed system (a prototype developed by the investigators) will be used to deliver small electrical currents to the arm. We hypothesize that the currents delivered to the arm will improve the accuracy of the movements performed by study participants.

To assess if delivering small currents to the arm has an effect on the accuracy of the movements performed by the study participants, they will receive actual stimulation for some trials and sham stimulation for other trials. Because the investigators will deliver very small currents, study participants will be unable to perceive such currents and hence tell if they are performing the movements while receiving actual or sham stimulation. By comparing trials performed while subjects receive actual stimulation with trials performed while subjects received sham stimulation, the investigators will determine if the stimulation has an effect on the accuracy of the movements performed by the subjects.

It is worth noticing that the investigators collected primary outcome data to assess changes associated with the use of actual stimulation vs sham stimulation. Data during a follow-up session was also collected, but not for the purpose of collecting outcome measures.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unilateral and cortical, subcortical, or cerebellar stroke
  • 6 months post-stroke
  • Upper extremity impairments but able to move upper extremity against gravity 25% of the range
  • Ability to understand directions and follow simple instructions
  • Medically stable
  • Upper Extremity Fugl-Meyer between 28 and 55
  • At least four (4) months since last botox treatment
  • Mini-Mental State Examination (MMSE) ≥ 23

Exclusion Criteria:

  • Participation in other forms of therapy/ intervention for upper extremity motor recovery
  • Upper extremity or trunk fractures
  • Severe fixed contractures affecting the upper limbs
  • Severe perceptual deficits or visual field impairments
  • Severe cognitive deficits
  • Pregnant women
  • Presence of an implanted electrically operated medical device
  • Evidence of more than one clinical stroke
  • Serious medical or neurological illness
  • History of head trauma or cerebral infectious disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689883

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Wyss Institute at Harvard University
Center for Integration of Medicine & Innovative Technology
Investigators
Principal Investigator: Paolo Bonato, PhD Spaulding Rehabilitation Hospital
  More Information

Responsible Party: Yong-Tae Lee, Physiatrist, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01689883     History of Changes
Other Study ID Numbers: 2011-P-001592
Study First Received: September 10, 2012
Last Updated: April 20, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yong-Tae Lee, Spaulding Rehabilitation Hospital:
stroke
electrical stimulation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 19, 2017