StrokeNCT03965403

Upper Extremity Rehabilitation With the BURT Robotic Arm

A study testing Arm motor function retraining with BURT in people with Stroke and Hemiparesis, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stroke, Hemiparesis
What is being tested?: Arm motor function retraining with BURT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 23 Oct 2018to 16 May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129

Other trials in United States

About this study

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

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
Being tested: Arm motor function retraining with BURT
Keywords: stroke, hemiparesis, Robotic
Medical subject headings: Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03965403
Study group	Role	What they receive
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. Receives: Device: Arm motor function retraining with BURT

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 weeks

Secondary outcomes (1)

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.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 201816 May 2019

First posted29 May 2019
Study start23 Oct 2018
Primary completion16 May 2019
Study completion16 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: All participants will receive the same intervention
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03965403
Sponsor's protocol ID: 2016P002590
Status last verified: Feb 2020
First submitted: 3 Apr 2019
Last updated: 19 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Upper Extremity Rehabilitation With the BURT Robotic Arm: a Feasibility Study
ClinicalTrials.gov ID: NCT03965403
Acronym / sponsor ID: 2016P002590
Conditions: Stroke, Hemiparesis
Keywords: stroke, hemiparesis, Robotic
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Spaulding Rehabilitation HospitalUniversity, hospital or other
Study start: 23 Oct 2018 (actual)
Primary completion: 16 May 2019 (actual)
Study completion: 16 May 2019 (actual)
First posted: 29 May 2019 (actual)
Results: Posted 19 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All participants will receive the same intervention

Arm	Type	Receives
Arm motor function retraining with BURT	Experimental	Device: Arm motor function retraining with BURTAll 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

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.

1 secondary outcome

Changes From Baseline in Goal Attainment Scale Scores
Time frame: 6 weeks

Results and safety

Results posted to the registry on 19 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm Motor Function Retraining With BURT	7	6

Primary outcome: Changes From Baseline in Fugl-Meyer Upper Extremity Scores

Time frame: 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm Motor Function Retraining With BURT n = 6
Value	3.50 (5.79)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: We collected information in regard to potential adverse events during the 6 weeks of the study intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm Motor Function Retraining With BURT	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Stroke

Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Arm motor function retraining with BURT in people with Stroke and Hemiparesis, run by Spaulding Rehabilitation Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes From Baseline in Fugl-Meyer Upper Extremity Scores (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03965403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.