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Clinical Trials/NCT03965403
NCT03965403
Completed
Not Applicable

Upper Extremity Rehabilitation With the BURT Robotic Arm: a Feasibility Study

Spaulding Rehabilitation Hospital1 site in 1 country7 target enrollmentOctober 23, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Spaulding Rehabilitation Hospital
Enrollment
7
Locations
1
Primary Endpoint
Changes From Baseline in Fugl-Meyer Upper Extremity Scores
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The overall objective of the proposed study is to carry out usability and design-evaluation assessments of the BURT robotic device for delivering long-term intervention in stroke survivors. The BURT is an upper extremity robotic device that enables the user to see and feel engaging games that encourage intensive therapy. The investigators intend to recruit up to 10 stroke survivors over the course of the study. Participants will train their arm with the BURT for 18 sessions over approximately 6 weeks then participate in a question/answer formatted discussion with research staff to discuss the usability of the device. The investigators will also assess participant's arm function at baseline and after the training sessions.

Registry
clinicaltrials.gov
Start Date
October 23, 2018
End Date
May 16, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Spaulding Rehabilitation Hospital
Responsible Party
Principal Investigator
Principal Investigator

Paolo Bonato

Principal Investigator, Director of the Motion Analysis Laboratory

Spaulding Rehabilitation Hospital

Eligibility Criteria

Inclusion Criteria

  • Male and female, age 18-80;
  • Having had a stroke (ischemic or hemorrhagic) at least 6 months prior to study
  • Moderate to severe upper-limb motor impairments (score of 15-45 out of 66 on the Fugl- Meyer Scale);
  • Community dwelling;
  • Able to physically fit in the device.

Exclusion Criteria

  • Current participation in rehabilitation program targeting upper extremity function;
  • Cognitive impairment resulting to inability to follow instructions or inability to sustain attention for more than 10 minutes;
  • Visual impairments not corrected with lenses (visual loss);
  • Aphasia sufficient to limit comprehension and completion of the treatment protocol;
  • No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy;
  • Increased muscle tone (passive movement is difficult);
  • Previous diagnosis of neurological diseases other than stroke;
  • Other conditions affecting function of the stroke affected upper limb;
  • Individuals who present with the following: open wounds, fragile skin, active infection

Outcomes

Primary Outcomes

Changes From Baseline in Fugl-Meyer Upper Extremity Scores

Time Frame: 6 weeks

Assessment of upper extremity impairments. Individual items of the scale are summed for a total score ranking from 0 to 66. Higher scores indicate better outcomes.

Secondary Outcomes

  • Changes From Baseline in Goal Attainment Scale Scores(6 weeks)

Study Sites (1)

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