StrokeNCT00333983

Evaluation of Robotic Arm Rehabilitation in Stroke Patients

A study testing Robotic Upper Extremity Neurorehabilitation and Traditional Upper Extremity Exercise Group in people with Stroke, run by US Department of Veterans Affairs 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

The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: Robotic Upper Extremity Neurorehabilitation and Traditional Upper Extremity Exercise Group
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited States
Study dates: Jun 2006to Feb 2011
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must have a clinically, defined, unilateral, hemiparetic stroke with radiologic exclusion of other diagnoses
Stroke onset greater than six months before randomization for ischemic stroke patients and one year before randomization for hemorrhagic stroke patients
A grade 3 or lower in Manual Muscle Test in the hemiparetic elbow flexion and shoulder abduction

Who cannot join

Subjects unable to give informed consent
Serious complicating medical illness
Contracture or orthopedic problems limiting the range of joint movement in the study arm
Visual loss
Stroke occurred within 6 months for ischemic stroke patients, one year for hemorrhagic patients
Botox treatment within 3 months of enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201

Other trials in United States

About this study

The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.

Read the detailed description

A robotic exercise device has been developed(MIT-MANUS)capable of providing therapy to the arm for patients with weakness due to stroke. The randomized trial will compare conventional care, planar robot intervention and an intervention of planar and vertical robot training among patients with chronic, stable deficits. We will evaluate motor outcomes, effectiveness, cost, patient satisfaction and quality of life. The study will determine the efficacy of upper extremity robot therapy compared to supervised self-administered exercise therapy in patients with deficits due to stroke.

Conditions: Stroke
Being tested: Robotic Upper Extremity Neurorehabilitation, Traditional Upper Extremity Exercise Group
Medical subject headings: Stroke

What participants receive

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

Robotic Upper Extremity NeurorehabilitationDevice
Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot
Traditional Upper Extremity Exercise GroupOther
Upper extremity stretching, skateboard reaching activities, and arm ergometer

Study groups in NCT00333983
Study group	Role	What they receive
Arm 1	Experimental	Robot Exercise Group Receives: Device: Robotic Upper Extremity Neurorehabilitation
Arm 2	Active comparator	Traditional Upper Extremity Exercise Group Receives: Other: Traditional Upper Extremity Exercise Group

What is being measured

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

Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, \& Steglind, 1975; Gladstone, Danells, \& Black, 2002).
Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully.
The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome.
Measured: Baseline to Final Training (6 weeks)

Timeline

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

Jun 2006Feb 2011

First posted6 Jun 2006 (estimated)
Study startJun 2006
Primary completionApr 2010
Study completionFeb 2011

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.
Publications (1)Papers the sponsor has linked to this study.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00333983
Sponsor's protocol ID: B3833-R
Status last verified: Feb 2014
First submitted: 2 Jun 2006
Last updated: 20 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Conroy SS, Whitall J, Dipietro L, Jones-Lush LM, Zhan M, Finley MA, Wittenberg GF, Krebs HI, Bever CT. Effect of gravity on robot-assisted motor training after chronic stroke: a randomized trial. Arch Phys Med Rehabil. 2011 Nov;92(11):1754-61. doi: 10.1016/j.apmr.2011.06.016. Epub 2011 Aug 17.
PubMed 21849168

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

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Robotic Arm Rehabilitation in Stroke Patients
ClinicalTrials.gov ID: NCT00333983
Acronym / sponsor ID: B3833-R
Conditions: Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Study start: Jun 2006
Primary completion: Apr 2010 (actual)
Study completion: Feb 2011 (actual)
First posted: 6 Jun 2006 (estimated)
Results: Posted 20 Mar 2014

Clinical summary

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

The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Device: Robotic Upper Extremity NeurorehabilitationRobot Exercise Group
Arm 2	Active comparator	Other: Traditional Upper Extremity Exercise GroupTraditional Upper Extremity Exercise Group

Who may qualify

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

Key inclusion criteria (3 listed)

Subjects must have a clinically, defined, unilateral, hemiparetic stroke with radiologic exclusion of other diagnoses
Stroke onset greater than six months before randomization for ischemic stroke patients and one year before randomization for hemorrhagic stroke patients
A grade 3 or lower in Manual Muscle Test in the hemiparetic elbow flexion and shoulder abduction

Key exclusion criteria (6 listed)

Subjects unable to give informed consent
Serious complicating medical illness
Contracture or orthopedic problems limiting the range of joint movement in the study arm
Visual loss
Stroke occurred within 6 months for ischemic stroke patients, one year for hemorrhagic patients

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
Robotic Upper Extremity NeurorehabilitationUpper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot	Device	Arm 1
Traditional Upper Extremity Exercise GroupUpper extremity stretching, skateboard reaching activities, and arm ergometer	Other	Arm 2

Primary outcome

Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment
Time frame: Baseline to Final Training (6 weeks)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, \& Steglind, 1975; Gladstone, Danells, \& Black, 2002). Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome.

Results and safety

Results posted to the registry on 20 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Planar Robot	20	17
Planar + Vertical Robot	21	16
Intensive Conventional Exercise	21	19

Primary outcome: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment

Time frame: Baseline to Final Training (6 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Planar Robot n = 20	Planar + Vertical n = 21	Intensive Conventional Exercise n = 21
Value	3.27 (3.27)	2.51 (3.33)	1.82 (4.24)

Planar Robot vs Planar + Vertical vs Intensive Conventional Exercise: p = .025, Mixed Models Analysis

Population analysed: The number of participants analyzed were based on an intention to treat methodology with the exception of individuals that were non-compliant with the protocol or did not progress to the midpoint (3 week) evaluation.

Adverse events

Time frame: Adverse event data was collected over a 6 month time period for each participant which included baseline testing, intervention and retention.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Planar Robot	0 of 20 (0%)	2 of 20 (10%)	Not reported
Planar + Vertical Robot	0 of 21 (0%)	1 of 21 (4.8%)	Not reported
Intensive Conventional Exercise	0 of 21 (0%)	1 of 21 (4.8%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated early with the current number of subjects analyzed. A midstudy futility analysis showed a need for 99 participants per group to determine signifcance between the robotic training over the intensive conventional exercise.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21849168Conroy SS, Whitall J, Dipietro L, Jones-Lush LM, Zhan M, Finley MA, Wittenberg GF, Krebs HI, Bever CT. Effect of gravity on robot-assisted motor training after chronic stroke: a randomized trial. Arch Phys Med Rehabil. 2011 Nov;92(11):1754-61. doi: 10.1016/j.apmr.2011.06.016. Epub 2011 Aug 17.

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

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.

Christopher Bever, MD principal investigator

VA Maryland Health Care System, Baltimore

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

Questions about this trial

What is this clinical trial studying?

A study testing Robotic Upper Extremity Neurorehabilitation and Traditional Upper Extremity Exercise Group in people with Stroke, run by US Department of Veterans Affairs 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 3 inclusion and 6 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 20 Mar 2014. 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 20 Mar 2014). 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?

Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment (time frame: Baseline to Final Training (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 NCT00333983, which also lists 1 linked publication.

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 20 Mar 2014.