PostureCheck: A Vision-based Compensatory-posture-detection Tool for Robot-assisted Upper-limb Th… (NCT04851886) | Clinical Trial Compass
RecruitingNot Applicable
PostureCheck: A Vision-based Compensatory-posture-detection Tool for Robot-assisted Upper-limb Therapy
United States42 participantsStarted 2024-04-26
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 proprio…
What they're measuring
1
Change from baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE) at 7-8 weeks
Timeframe: Data will be collected at baseline and at 7-8 weeks