No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
42 (estimated)
Sponsor
Spaulding Rehabilitation Hospital · Other
Who this trial is looking for
This trial is looking for people who have had a stroke and need help with arm recovery. Participants will receive robot-assisted therapy either one-on-one or in small groups while their exercise performance is tracked by a camera system.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a stroke within the last six years.
I have moderate to severe arm impairment.
I can follow three-step commands safely.
My Mini-Mental State Examination score is above 23.
You may not be able to join if
I have a serious injury or recent fracture in my affected arm.
I have been diagnosed with another neurological disease.
I have severe movement limitations or spasticity.
I have had a different type of stroke or issues in specific brain areas.
I have trouble communicating my needs or discomfort.
I have serious visual impairments.
I have severe neglect of one side of my body.
I have severely impaired control of my trunk.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The overall objective of this study is to assess whether robot-assisted upper-limb group rehabilitation can be effectively delivered by using a camera-based system equipped with machine learning algorithms to track the quality of the exercise performance and provide feedback accordingly. To address this question, we plan to carry out a randomized clinical trial to compare outcomes in subjects rece…
The overall objective of this study is to assess whether robot-assisted upper-limb group rehabilitation can be effectively delivered by using a camera-based system equipped with machine learning algorithms to track the quality of the exercise performance and provide feedback accordingly. To address this question, we plan to carry out a randomized clinical trial to compare outcomes in subjects receiving robot-assisted upper-limb rehabilitation during individual (i.e., one-on-one) sessions and in subjects receiving robot-assisted upper-limb rehabilitation during group (i.e., up to three subjects) sessions.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Have had a history of ischemic cerebrovascular accident (CVA) within middle cerebral artery (MCA) or anterior cerebral artery (ACA) territory
* CVA occurred between six months and six years ago
* Moderate to severe UE impairment, FMA-UE score between 15 and 45
* Mini-Mental St…
Inclusion Criteria:
* Have had a history of ischemic cerebrovascular accident (CVA) within middle cerebral artery (MCA) or anterior cerebral artery (ACA) territory
* CVA occurred between six months and six years ago
* Moderate to severe UE impairment, FMA-UE score between 15 and 45
* Mini-Mental State Examination (MMSE) score \>23 and being able to safely follow three-step commands
Exclusion Criteria:
* Advanced musculoskeletal pathology or recent fractures in the impaired UE
* Previous diagnosis of neurological diseases other than stroke
* Severe limitation of passive range of motion or spasticity (Modified Ashworth Scale for spasticity at \<3 for UE muscles)
* Hemorrhagic CVA or involvement of the posterior cerebral artery
* Aphasia sufficient to limit ability to express needs or discomfort verbally or non-verbally
* Impaired visual acuity (Severe visual impairments as assessed by the NIH Stroke Scale Visual Field subscale. (score \>0))
* Severe hemispatial neglect as assessed by the Line Bisection Test (score \>2)
* Severely impaired trunk control (\<4)
* Individuals who present with the following on the intended limb:
* Open wounds
* Fragile skin
* Under contact precautions due to an active infection
* Participation in another therapy focused on recovery of the impaired arm
* Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices, that are not US-certified
* Any Condition that would prevent safe use of the Burt system; such as proprioceptive deficits that impair the ability to process haptic or visual feedback, or unstable shoulder joint as assessed by physical examination
* Current pregnancy (self-report)
* The concern is strictly towards women who are in the 2nd or 3rd trimester and the eventuality of the arm of the BURT accidentally impacting the woman's belly. The system does have safety features (including a virtual safety wall, to keep the device away from the patient's body) but we are taking this as an extra precaution against any potential harm
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