Upper Extremity Rehabilitation With the BURT Robotic Arm

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03965403
• Other study ID #: 2016P002590
• Status: Completed
• Phase: N/A
• Start date: October 23, 2018
• Est. completion date: May 16, 2019

Study information

• Verified date: February 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 16, 2019
• Est. primary completion date: May 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Device:
• Arm motor function retraining with BURT
Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale)	Assessment of upper-extremity function by the performance time of the Wolf Motor Function Test). The average of the 15 items is reported. The time ranges from 0 to 120 seconds. A decrease in performance time is associated with improved upper-extremity function.	6 weeks
Other	Changes From Baseline in Motor Activity Log Scores	Use of upper extremity in daily life. The self-reported amount of use is reported on a scale from 0 to 5. A score of zero is assigned when the hemiparetic side is not used during the activity of daily living, a score of 5 is assigned when the hemiparetic side is used as much as before the stroke. The 30 items of the scale are averaged. Higher scores are a sign of better use in daily life.	6 weeks
Other	Changes From Baseline in Modified Ashworth Scale Scores	Assessment of muscle tone for upper extremity muscles. Score rank from 0 (no tone) to 4 (no movement possible). Lower scores indicates a better outcome.; Tone at the shoulder and elbow were measured	6 weeks
Other	Changes From Baseline in Articulations Range of Motion	Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes.	6 weeks
Other	Changes From Baseline in Manual Muscle Testing Scale Scores	Assessment of arm muscle strength using the manual muscle testing scale ranking from 0 (no contraction) to 10 (maximal strength). Higher scores indicate better outcomes.	6 weeks
Other	Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale)	Assessment of upper-extremity function with the Functional ability subscale of the Wolf Motor Function Test.; The average of the 15 items is reported. Scores ranges from 0 to 5, they rate the quality of the movement performance. 0= do not attempt, up to 5= identical to contralateral side. Higher scores are associated with better movement quality.	6 weeks
Primary	Changes From Baseline in Fugl-Meyer Upper Extremity Scores	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.	6 weeks
Secondary	Changes From Baseline in Goal Attainment Scale Scores	Standardized measure of goals selection and scaling to calculate the extend to which the participant's goals are met.; The Goal Attainment Scale ranges from -2 to +2. Positive scores indicates goals are better than expected, score of 0 indicates goals are met and negative scores indicates goals aren't met.	6 weeks