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

September 10, 2012
March 18, 2014
August 2011
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01689883 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
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 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Chronic Stroke Survivors
  • 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.
  • Active Comparator: SR stimulation
    Interventions:
    • Device: Armeo Spring
    • Device: Stochastic Resonance Stimulation
  • Sham Comparator: Sham stimulation
    Intervention: Device: Armeo Spring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01689883
2011-P-001592
No
Yong-Tae Lee, Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
  • Wyss Institute for Biologically Inspired Engineering at Harvard University
  • Center for Integration of Medicine and Innovative Technology (CIMIT)
Principal Investigator: Paolo Bonato, PhD Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP