Clinical trial NCT03965403: Upper Extremity Rehabilitation With the BURT Robotic Arm
Official title: Upper Extremity Rehabilitation With the BURT Robotic Arm: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: stroke
hemiparesis
Robotic
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the same intervention
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Changes From Baseline in Fugl-Meyer Upper Extremity Scores
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes From Baseline in Goal Attainment Scale Scores
timeFrame: 6 weeks
Other outcomes:
measure: Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale)
timeFrame: 6 weeks
measure: Changes From Baseline in Motor Activity Log Scores
timeFrame: 6 weeks
measure: Changes From Baseline in Modified Ashworth Scale Scores
timeFrame: 6 weeks
measure: Changes From Baseline in Articulations Range of Motion
timeFrame: 6 weeks
measure: Changes From Baseline in Manual Muscle Testing Scale Scores
timeFrame: 6 weeks
measure: Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale)
timeFrame: 6 weeks
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
References: