Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors

NCT01689883 | Terminated

• 1 other identifier: 2011-P-001592
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke Survivors

Keywords

stroke; electrical stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Jebsen-Taylor Hand Function Test

  Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation

• Motor Activity Log

  Change in Motor Activity Log score with vs without stimulation

• Modified Ashworth Scale

  Change in Modified Ashworth Scale score with vs without stimulation

• Box and Block test

  Change in Box and Block test score with vs without stimulation

• Grip strength

  Change in grip strength with vs without stimulation

Study Arms (1)

Current stimulator

OTHER

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

Interventions

Current stimulator DEVICE

This is a device developed by the investigators to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.

Current stimulator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral and cortical, subcortical, or cerebellar stroke
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Wyss Institute at Harvard University: collaborator
• Center for Integration of Medicine & Innovative Technology: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiatrist

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 21, 2012
• Study Start: August 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)