This trial is active, not recruiting.

Condition chronic stroke survivors
Treatments armeo spring, stochastic resonance stimulation
Sponsor Spaulding Rehabilitation Hospital
Collaborator Wyss Institute for Biologically Inspired Engineering at Harvard University
Start date August 2011
End date September 2016
Trial size 20 participants
Trial identifier NCT01689883, 2011-P-001592


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
(Active Comparator)
armeo spring Hocoma (Zurich, Switzerland)
Upper extremity robotic device for rehabilitation
stochastic resonance stimulation
Device that produces sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.
(Sham Comparator)
armeo spring Hocoma (Zurich, Switzerland)
Upper extremity robotic device for rehabilitation

Primary Outcomes

Evidence of improved upper extremity mobility
time frame: baseline; end of treatment (10 days); follow up (1 month after end of treatment)

Secondary Outcomes

Evidence of improved upper extremity mobility.
time frame: baseline; end of treatment (10 days); follow up (1 month after end of treatment)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
Principal investigator Paolo Bonato, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.