Health TrialsbyHealthPanel

PostureCheck: A Vision-based Compensatory-posture-detection Tool for Robot-assisted Upper-limb Therapy

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSpaulding Rehabilitation Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • BURT

    Device

    Robot-assisted upper-limb individual (i.e. one-on-one) rehabilitation will be delivered using the BURT system by Barrett Technology

  • BURT + PostureCheck

    Device

    Robot-assisted upper-limb group (i.e. up to three subjects) rehabilitation will be delivered using the BURT system by Barrett Technology + PostureChek (a camera-based system to track the quality of the exercises)

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Individual robot-assisted upper-limb rehabilitationActive comparator 1 intervention
Group B: Group robot-assisted upper-limb rehabilitationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE) at 7-8 weeks

Standard assessment of the severity of upper-limb motor impairments

Time frame
Data will be collected at baseline and at 7-8 weeks

Secondary outcomes

1

Change from baseline Wolf Motor Function Test (WMFT) at 7-8 weeks

Standard assessment of functional limitations

Time frame
Data will be collected at baseline and at 7-8 weeks
2

Change from baseline Motor Activity Log (MAL) at 7-8 weeks

Self-report of amount and quality of use of the stroke-affected upper limb

Time frame
Data will be collected at baseline and at 7-8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spaulding Rehabilitation Hospital

Lead sponsor

Barrett Technology

Collaborator

Source ClinicalTrials.gov
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