42 Participants NeededMy employer runs this trial

Robot-Assisted Therapy for Stroke

GS
CA
DT
FB
Overseen ByFederico Bauducco, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Spaulding Rehabilitation Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a robot-assisted therapy, known as BURT (Barrett Upper Extremity Robot), can aid in recovering arm movement after a stroke. Researchers will compare two setups: one-on-one therapy with a therapist and group therapy with up to three participants, using a camera system to monitor exercise quality. It suits individuals who experienced a stroke affecting arm movement between six months and six years ago and can follow simple instructions. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance stroke recovery therapies.

What prior data suggests that this robot-assisted therapy is safe for stroke rehabilitation?

Previous studies have shown that the BURT robotic arm is safe and effective for helping people regain arm strength and movement after a stroke. The FDA has approved it for this purpose. Research indicates that patients using BURT often improve their arm function. No major safety issues have been reported, and participants generally handle the treatment well.

The PostureCheck system works with the BURT robot, using cameras and smart technology to monitor exercise performance. This system aims to enhance therapy without adding extra risks.

Overall, research has proven both the BURT robot and PostureCheck to be safe. Participants in past studies tolerated these treatments well and showed improvements in arm recovery.12345

Why are researchers excited about this trial?

Researchers are excited about the robot-assisted therapy for stroke because it offers a fresh approach to upper-limb rehabilitation. Unlike traditional physical therapy, which typically involves one-on-one sessions with a therapist, this innovative method incorporates a robot equipped with a camera system called PostureCheck. This technology can track the quality of exercises, potentially enhancing the effectiveness of the rehabilitation process. Additionally, the group therapy option allows multiple participants to receive treatment simultaneously, which could make therapy more accessible and efficient. These advancements could lead to improved recovery outcomes for stroke patients.

What evidence suggests that this trial's robot-assisted therapies could be effective for stroke rehabilitation?

Research has shown that robotic-assisted therapy, such as the BURT system, aids stroke patients in regaining movement. A review of 13 studies found that this therapy significantly improves arm function. In this trial, participants will receive either individual or group robot-assisted upper-limb rehabilitation using the BURT system. Patients using BURT have demonstrated improved strength and fine motor skills. The PostureCheck system, used in the group therapy arm to monitor exercise quality, enhances the effectiveness of these robotic therapies. Overall, these technologies show promise in helping stroke survivors regain arm movement.16789

Who Is on the Research Team?

PB

Paolo Bonato, PhD

Principal Investigator

Harvard Medical School (HMS and HSDM)

Are You a Good Fit for This Trial?

Inclusion Criteria

I had a stroke between six months and six years ago.
I have had a stroke in the middle or anterior part of my brain.
I have moderate to severe weakness or loss of movement in my arm.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 18 sessions of robot-assisted upper-limb rehabilitation, either individually or in groups, using the PostureCheck system

6 weeks
18 sessions (in-person)

Follow-up

Participants are monitored for changes in motor function and quality of use of the stroke-affected upper limb

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BURT
  • PostureCheck

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Group robot-assisted upper-limb rehabilitationExperimental Treatment1 Intervention
Group II: Individual robot-assisted upper-limb rehabilitationActive Control1 Intervention

BURT is already approved in United States for the following indications:

🇺🇸
Approved in United States as BURT for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials
143
Recruited
11,200+

Barrett Technology

Collaborator

Trials
1
Recruited
40+

Citations

Upper extremity rehabilitation with the BURT robotic arm

Only about 15% of those with initial complete upper limb paralysis after stroke recover the functional use of their impaired arm in daily life. Motor training ...

Systematic review and meta-analysis of effectiveness of ... - PMC

This meta-analysis of 13 randomized controlled trials provides consistent evidence that robotic-assisted therapy improves motor recovery in post ...

The role of early intervention with upper limb rehabilitation ...

Exercise training reduces post-stroke muscle loss. This study explores if rehabilitation robots enhance upper-limb function and muscle mass ...

Advanced Rehabilitation Technologies and Robotics

A cutting-edge piece of rehabilitation technology must not only produce good data from a technical outcome perspective, but be inclusive, ...

BURT Efficacy in Improving Upper Extremity Strength and ...

Patients who participate in neuro re-education activities using BURT will achieve greater improvements in strength, upper extremity function, fine motor ...

Robot-Assisted Therapy in Upper Extremity Hemiparesis - PMC

Typically, patients engaged in the robotic therapy showed an impairment reduction of 5 points or more in the Fugl-Meyer assessment as compared ...

BURT Efficacy in Improving Upper Extremity Strength and ...

The Barrett Upper Extremity Robot (BURT) is an FDA-approved upper extremity robot that assists patients with both passive and active range of ...

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barrett.com

barrett.com/burt

Burt® Rehabilitation Robot | Upper-Limb Robotic Therapy ...

Therapists can set goals, monitor progression across sessions, and use the data to adjust treatment plans or report outcomes to administrators and insurers.

Upper Extremity Rehabilitation With the BURT Robotic Arm

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 ...