N/A
N=7
Upper Extremity Rehabilitation With the BURT Robotic Arm
Stroke · Hemiparesis
Bottom Line
View on ClinicalTrials.gov: NCT03965403 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Changes From Baseline in Fugl-Meyer Upper Extremity Scores — 3.50 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Arm motor function retraining with BURT (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes From Baseline in Fugl-Meyer Upper Extremity Scores |
3.50 | — |
| SECONDARY Changes From Baseline in Goal Attainment Scale Scores |
0.22 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03965403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.