Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors

Chronic Stroke Survivors Clinical Trial

Official title:

Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01689883
• Other study ID #: 2011-P-001592
• Status: Terminated
• Phase: N/A
• First received: September 10, 2012
• Last updated: April 20, 2017
• Start date: August 2011
• Est. completion date: July 2013

Study information

• Verified date: April 2017
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke Survivors
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital Boston	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	Center for Integration of Medicine & Innovative Technology, Wyss Institute at Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment	Subjects are asked to perform upper-limb movements from which a therapist can assess the severity of movement abnormalities (e.g. flexion synergies)	Changes in Fugl-Meyer Assessment score with vs without stimulation
Secondary	Jebsen-Taylor Hand Function Test	Subjects are asked to perform a set of functional movements from which a therapist can assess subjects' functional limitations	Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation
Secondary	Motor Activity Log	Subjects are asked about the amount and quality of use of their stroke-affected arm during the performance of daily activities	Change in Motor Activity Log score with vs without stimulation
Secondary	Modified Ashworth Scale	A therapist examines subjects to assess the severity of spasticity	Change in Modified Ashworth Scale score with vs without stimulation
Secondary	Box and Block test	Subjects are asked to move as many small wooden blocks as possible from one to box to another in a set amount of time	Change in Box and Block test score with vs without stimulation
Secondary	Grip strength	A hand dynamometer is used to measure grip strength	Change in grip strength with vs without stimulation