Upper Extremity Rehabilitation With the BURT Robotic Arm

NCT03965403 | Completed Results FDA Device

• 1 other identifier: 2016P002590
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparesis

Keywords

stroke; hemiparesis; Robotic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes From Baseline in Goal Attainment Scale Scores

  6 weeks

Other Outcomes (6)

• Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale)

  6 weeks

• Changes From Baseline in Motor Activity Log Scores

  6 weeks

• Changes From Baseline in Modified Ashworth Scale Scores

  6 weeks

Study Arms (1)

Arm motor function retraining with BURT

EXPERIMENTAL

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

Interventions

Arm motor function retraining with BURT DEVICE

Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions

Arm motor function retraining with BURT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Paolo Bonato, PhD
• Organization: Spaulding Rehabilitation Hospital

pbonato@partners.org

6179526319

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of the Motion Analysis Laboratory

Model Details: All participants will receive the same intervention

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: May 29, 2019
• Study Start: October 23, 2018
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)