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New treatment option for Stroke
Official title PostureCheck: A Vision-based Compensatory-posture-detection Tool for Robot-assisted Upper-limb Therapy
ClinicalTrials.gov ID: NCT04851886
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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))
See the full eligibility 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
- 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
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Charlestown, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlestown, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.