Chronic Stroke SurvivorsNCT01689883
Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
A study testing Current stimulator in people with Chronic Stroke Survivors, run by Spaulding Rehabilitation Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Stroke Survivors
- What is being tested?
- Current stimulator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, 02129
About this study
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.
Read the 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.
- Conditions
- Chronic Stroke Survivors
- Being tested
- Current stimulator
- Keywords
- stroke, electrical stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current stimulatorDevice
This is a device developed by the investigators to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.
| Study group | Role | What they receive |
|---|---|---|
| Current stimulator | Other | 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. Receives: Device: Current stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Changes in Fugl-Meyer Assessment score with vs without stimulation
Secondary outcomes (5)
Jebsen-Taylor Hand Function Test
Subjects are asked to perform a set of functional movements from which a therapist can assess subjects' functional limitations
Measured: Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation
Motor Activity Log
Subjects are asked about the amount and quality of use of their stroke-affected arm during the performance of daily activities
Measured: Change in Motor Activity Log score with vs without stimulation
Modified Ashworth Scale
A therapist examines subjects to assess the severity of spasticity
Measured: Change in Modified Ashworth Scale score with vs without stimulation
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
Measured: Change in Box and Block test score with vs without stimulation
Grip strength
A hand dynamometer is used to measure grip strength
Measured: Change in grip strength with vs without stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stroke SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wyss Institute at Harvard University, Center for Integration of Medicine & Innovative Technology
- Responsible party
- Principal investigator, Yong-Tae Lee, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689883
- Sponsor's protocol ID
- 2011-P-001592
- Status last verified
- Apr 2017
- First submitted
- 10 Sep 2012
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
- ClinicalTrials.gov ID
- NCT01689883
- Acronym / sponsor ID
- 2011-P-001592
- Conditions
- Chronic Stroke Survivors
- Keywords
- stroke, electrical stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Wyss Institute at Harvard University, Center for Integration of Medicine & Innovative Technology
- Study start
- Aug 2011 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Current stimulator | Other | Device: Current stimulatorThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Current stimulatorThis is a device developed by the investigators to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin. | Device | Current stimulator |
Primary outcome
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)
5 secondary outcomes
Jebsen-Taylor Hand Function Test
Time frame: Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation
Motor Activity Log
Time frame: Change in Motor Activity Log score with vs without stimulation
Modified Ashworth Scale
Time frame: Change in Modified Ashworth Scale score with vs without stimulation
Box and Block test
Time frame: Change in Box and Block test score with vs without stimulation
Grip strength
Time frame: Change in grip strength with vs without stimulation
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Bonato, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current stimulator in people with Chronic Stroke Survivors, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (time frame: Changes in Fugl-Meyer Assessment score with vs without stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.