Upper Extremity Rehabilitation With the BURT Robotic Arm

• ClinicalTrials.gov Identifier: NCT03965403
• Recruitment Status: Completed
• First Posted: May 29, 2019
• Results First Posted: February 19, 2020
• Last Update Posted: February 19, 2020
• Sponsor: Spaulding Rehabilitation Hospital
• Information provided by (Responsible Party): Paolo Bonato, Spaulding Rehabilitation Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke; Hemiparesis	Device: Arm motor function retraining with BURT	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All participants will receive the same intervention
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Upper Extremity Rehabilitation With the BURT Robotic Arm: a Feasibility Study
• Actual Study Start Date: October 23, 2018
• Actual Primary Completion Date: May 16, 2019
• Actual Study Completion Date: May 16, 2019

Arms and Interventions

Arm

Intervention/treatment

Experimental: Arm motor function retraining with BURT; All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Changes From Baseline in Goal Attainment Scale Scores [ Time Frame: 6 weeks ]

   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.

Other Outcome Measures:

1. Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale) [ Time Frame: 6 weeks ]
   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.
2. Changes From Baseline in Motor Activity Log Scores [ Time Frame: 6 weeks ]
   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.
3. Changes From Baseline in Modified Ashworth Scale Scores [ Time Frame: 6 weeks ]

   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

4. Changes From Baseline in Articulations Range of Motion [ Time Frame: 6 weeks ]
   Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes.
5. Changes From Baseline in Manual Muscle Testing Scale Scores [ Time Frame: 6 weeks ]
   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. Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale) [ Time Frame: 6 weeks ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States, 02129

Sponsors and Collaborators

Spaulding Rehabilitation Hospital

  Study Documents (Full-Text)

Documents provided by Paolo Bonato, Spaulding Rehabilitation Hospital:

Study Protocol  [PDF] October 5, 2018

No Statistical Analysis Plan (SAP) exists for this study.

More Information

• Responsible Party: Paolo Bonato, Principal Investigator, Director of the Motion Analysis Laboratory, Spaulding Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT03965403
• Other Study ID Numbers: 2016P002590
• First Posted: May 29, 2019
• Results First Posted: February 19, 2020
• Last Update Posted: February 19, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Paolo Bonato, Spaulding Rehabilitation Hospital:

stroke; hemiparesis; Robotic

Additional relevant MeSH terms:

Paresis; Nervous System Diseases; Neurologic Manifestations