PostureCheck: A Vision-based Compensatory-posture-detection Tool to Enhance Performance of the BURT Upper-extremity Stroke-therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Spaulding Rehabilitation Hospital
- Enrollment
- 42
- Primary Endpoint
- Change from baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE) at 7-8 weeks
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
The proposed study is a single-blinded randomized clinical trial to evaluate the effect of using the PostureCheck (a camera-based system equipped with machine learning algorithms to track the quality of the exercise performance) on motor gains in group and individual robot-assisted upper-limb. Study participants (stroke survivors) will be recruited at the Spaulding Rehabilitation Hospital - Boston. Subjects will be randomly assigned to one of the two different groups: individual- or group-therapy using a covariate-adaptive allocation procedure to ensure important covariates, such as baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores and proprioceptive deficits, are balanced between groups.
Investigators
Paolo Bonato
Director, Motion Analysis Laboratory
Spaulding Rehabilitation Hospital
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 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
Outcomes
Primary Outcomes
Change from baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE) at 7-8 weeks
Time Frame: Data will be collected at baseline and at 7-8 weeks
Standard assessment of the severity of upper-limb motor impairments
Secondary Outcomes
- Change from baseline Motor Activity Log (MAL) at 7-8 weeks(Data will be collected at baseline and at 7-8 weeks)
- Change from baseline Wolf Motor Function Test (WMFT) at 7-8 weeks(Data will be collected at baseline and at 7-8 weeks)