Clinical trial NCT01689883: Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
Official title: Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Stroke Survivors
Keywords: stroke
electrical stimulation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Wyss Institute at Harvard University
name: Center for Integration of Medicine & Innovative Technology
First posted: 2012-09-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Study participants will be instructed to perform upper-limb movements using a system designed for upper-limb rehabilitation (Armeo Spring by Hocoma AG). The system provides subjects with 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 the investigators) 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 study participants.

To assess if delivering small currents to the arm has an effect on the accuracy of the movements performed by the study participants, they will receive actual stimulation for some trials and sham stimulation for other trials. Because the investigators will deliver very small currents, study participants will be unable to perceive such currents and hence tell if they are performing the movements while receiving actual or sham stimulation. By comparing trials performed while subjects receive actual stimulation with trials performed while subjects received sham stimulation, the investigators will determine if the stimulation has an effect on the accuracy of the movements performed by the subjects.

It is worth noticing that the investigators collected primary outcome data to assess changes associated with the use of actual stimulation vs sham stimulation. Data during a follow-up session was also collected, but not for the purpose of collecting outcome measures.

Eligibility 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 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

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: Changes in Fugl-Meyer Assessment score with vs without stimulation
Secondary outcomes:
measure: Jebsen-Taylor Hand Function Test
timeFrame: Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation
measure: Motor Activity Log
timeFrame: Change in Motor Activity Log score with vs without stimulation
measure: Modified Ashworth Scale
timeFrame: Change in Modified Ashworth Scale score with vs without stimulation
measure: Box and Block test
timeFrame: Change in Box and Block test score with vs without stimulation
measure: Grip strength
timeFrame: Change in grip strength with vs without stimulation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital Boston
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: