Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Wyss Institute for Biologically Inspired Engineering at Harvard University
Center for Integration of Medicine and Innovative Technology (CIMIT)
Information provided by (Responsible Party):
Yong-Tae Lee, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01689883
First received: September 10, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

The overall objective of the study is to test whether the use of small electrical currents to stimulate proprioceptors of the upper limb can result into enhancing the benefits of robotic-assisted therapy. The stimulation technique used is "Stochastic Resonance" (SR). In previous studies, it has been shown that SR has the effect of increasing afferent traffic from Golgi tendon organs and muscle spindles. This effect is referred to as "sensory enhancement". Also, SR has been shown to improve the results of physical therapy in an animal model. The study is intended to explore the use of SR in stroke survivors.


Condition Intervention
Chronic Stroke Survivors
Device: Armeo Spring
Device: Stochastic Resonance Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors

Resource links provided by NLM:


Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Evidence of improved upper extremity mobility [ Time Frame: baseline; end of treatment (10 days); follow up (1 month after end of treatment) ] [ Designated as safety issue: No ]
    Measured by grip strength and Box and Block test.


Secondary Outcome Measures:
  • Evidence of improved upper extremity mobility. [ Time Frame: baseline; end of treatment (10 days); follow up (1 month after end of treatment) ] [ Designated as safety issue: No ]
    Measured by Modified Ashworth Scale, Motor Activity Log, Jebsen-Taylor Hand Function Test and the upper extremity score of the Fugl-Meyer Assessment.


Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SR stimulation Device: Armeo Spring
Upper extremity robotic device for rehabilitation
Other Name: Hocoma (Zurich, Switzerland)
Device: Stochastic Resonance Stimulation
Device that produces sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.
Sham Comparator: Sham stimulation Device: Armeo Spring
Upper extremity robotic device for rehabilitation
Other Name: Hocoma (Zurich, Switzerland)

Detailed Description:

Aim 1: To establish a procedure to optimize the delivery of the SR stimulation to the target organs. The investigators hypothesize that there is an optimal level of stimulation for an individual that will lead to the highest level of sensory enhancement. The investigators will determine such level of stimulation by measuring the impact of different stimulation levels on the quality of the movements performed by subjects while being stimulated.

Aim 2: To gather preliminary evidence of the effectiveness of SR stimulation in stroke rehabilitation. The investigators plan to combine the optimal SR stimulation, determined in Aim 1, with robotic-assisted rehabilitation to perform a preliminary assessment of the size of the improvement associated with the delivery of SR stimulation. The investigators hypothesize that robotic-assisted rehabilitation in combination with SR stimulation of proprioceptors leads to larger motor gains than robotic-assisted rehabilitation alone.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 in the upper extremities
  • 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 for Biologically Inspired Engineering at Harvard University
Center for Integration of Medicine and Innovative Technology (CIMIT)
Investigators
Principal Investigator: Paolo Bonato, PhD Spaulding Rehabilitation Hospital
  More Information

No publications provided

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: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
stroke
electrical stimulation
arm rehabilitation

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

ClinicalTrials.gov processed this record on August 19, 2014