Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
Primary Purpose
Chronic Stroke Survivors
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Current stimulator
Sponsored by

About this trial
This is an interventional basic science trial for Chronic Stroke Survivors focused on measuring stroke, electrical stimulation
Eligibility 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
Sites / Locations
- Spaulding Rehabilitation Hospital Boston
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Current stimulator
Arm Description
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.
Outcomes
Primary Outcome Measures
Fugl-Meyer Assessment
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
Subjects are asked to perform a set of functional movements from which a therapist can assess subjects' functional limitations
Motor Activity Log
Subjects are asked about the amount and quality of use of their stroke-affected arm during the performance of daily activities
Modified Ashworth Scale
A therapist examines subjects to assess the severity of spasticity
Box and Block test
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
A hand dynamometer is used to measure grip strength
Full Information
NCT ID
NCT01689883
First Posted
September 10, 2012
Last Updated
April 20, 2017
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Wyss Institute at Harvard University, Center for Integration of Medicine & Innovative Technology
1. Study Identification
Unique Protocol Identification Number
NCT01689883
Brief Title
Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
Official Title
Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
August 2011 (Actual)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Wyss Institute at Harvard University, Center for Integration of Medicine & Innovative Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke Survivors
Keywords
stroke, electrical stimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Current stimulator
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Current stimulator
Intervention Description
This is a device developed by the investigators to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Description
Subjects are asked to perform upper-limb movements from which a therapist can assess the severity of movement abnormalities (e.g. flexion synergies)
Time Frame
Changes in Fugl-Meyer Assessment score with vs without stimulation
Secondary Outcome Measure Information:
Title
Jebsen-Taylor Hand Function Test
Description
Subjects are asked to perform a set of functional movements from which a therapist can assess subjects' functional limitations
Time Frame
Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation
Title
Motor Activity Log
Description
Subjects are asked about the amount and quality of use of their stroke-affected arm during the performance of daily activities
Time Frame
Change in Motor Activity Log score with vs without stimulation
Title
Modified Ashworth Scale
Description
A therapist examines subjects to assess the severity of spasticity
Time Frame
Change in Modified Ashworth Scale score with vs without stimulation
Title
Box and Block test
Description
Subjects are asked to move as many small wooden blocks as possible from one to box to another in a set amount of time
Time Frame
Change in Box and Block test score with vs without stimulation
Title
Grip strength
Description
A hand dynamometer is used to measure grip strength
Time Frame
Change in grip strength with vs without stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Bonato, PhD
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
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