Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Stroke Survivors
• Intervention / Treatment: Device: Current stimulator

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Spaulding Rehabilitation Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Changes in Fugl-Meyer Assessment score with vs without stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jebsen-Taylor Hand Function Test	Subjects are asked to perform a set of functional movements from which a therapist can assess subjects' functional limitations	Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation
Motor Activity Log	Subjects are asked about the amount and quality of use of their stroke-affected arm during the performance of daily activities	Change in Motor Activity Log score with vs without stimulation
Modified Ashworth Scale	A therapist examines subjects to assess the severity of spasticity	Change in Modified Ashworth Scale score with vs without stimulation
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	Change in Box and Block test score with vs without stimulation
Grip strength	A hand dynamometer is used to measure grip strength	Change in grip strength with vs without stimulation

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Collaborators: Wyss Institute at Harvard University; Center for Integration of Medicine & Innovative Technology

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: September 10, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: stroke; electrical stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2011-P-001592

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No