Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
|ClinicalTrials.gov Identifier: NCT01689883|
Recruitment Status : Terminated (Lack of funding)
First Posted : September 21, 2012
Last Update Posted : April 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Stroke Survivors||Device: Current stimulator||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors|
|Actual Study Start Date :||August 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
The investigators 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.
Device: Current stimulator
This is a device developed by the investigators to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.
- Fugl-Meyer Assessment [ Time Frame: Changes in Fugl-Meyer Assessment score with vs without stimulation ]Subjects are asked to perform upper-limb movements from which a therapist can assess the severity of movement abnormalities (e.g. flexion synergies)
- Jebsen-Taylor Hand Function Test [ Time Frame: Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation ]Subjects are asked to perform a set of functional movements from which a therapist can assess subjects' functional limitations
- Motor Activity Log [ Time Frame: Change in Motor Activity Log score with vs without stimulation ]Subjects are asked about the amount and quality of use of their stroke-affected arm during the performance of daily activities
- Modified Ashworth Scale [ Time Frame: Change in Modified Ashworth Scale score with vs without stimulation ]A therapist examines subjects to assess the severity of spasticity
- Box and Block test [ Time Frame: Change in Box and Block test score with vs without stimulation ]Subjects are asked to move as many small wooden blocks as possible from one to box to another in a set amount of time
- Grip strength [ Time Frame: Change in grip strength with vs without stimulation ]A hand dynamometer is used to measure grip strength
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689883
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital Boston|
|Boston, Massachusetts, United States, 02129|
|Principal Investigator:||Paolo Bonato, PhD||Spaulding Rehabilitation Hospital|