Upper Extremity Rehabilitation With the BURT Robotic Arm

NCT ID: NCT03965403

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-23
• Study Completion Date: 2019-05-16

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Arm motor function retraining with BURT

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paolo Bonato

Principal Investigator, Director of the Motion Analysis Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2016P002590

Identifier Type: -

Identifier Source: org_study_id