Overview

This trial has been terminated.

Condition chronic stroke survivors
Treatment current stimulator
Sponsor Spaulding Rehabilitation Hospital
Collaborator Wyss Institute at Harvard University
Start date August 2011
End date July 2013
Trial size 1 participant
Trial identifier NCT01689883, 2011-P-001592

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Intervention model description we 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.
Primary purpose basic science
Masking no masking
Arm
(Other)
We 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.
current stimulator
This is a device that we developed to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

All 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 Subjects will be instructed to perform upper-limb movements using a system designed for upper-limb rehabilitation (Armeo Spring by Hocoma AG). The system provides 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 our own research team) 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 the subjects. To assess if delivering small currents to the arm has an effect on the accuracy of the movements performed by the subjects, they will receive actual stimulation as well as sham stimulation. Because we will deliver very small currents, subjects will be unable to perceive them and hence tell if they are performing the movements while receiving actual or sham stimulation. By comparing trials performed while subjects received actual stimulation with trials performed while subjects received sham stimulation, we will determine if the stimulation has an effect on the accuracy of the movements performed by the subjects.
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.