StrokeROBOASSISTNCT03584477

Robotic Rehabilitation of the Upper Limb After a Stroke

A study testing Robot InMotion 2.0 and Conventional rehabilitation in people with Stroke, run by Clinique Les Trois Soleils at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Hemiparesis is the most common motor disorder after a stroke. Most patients do not recover functional use of their paretic upper limb. The use of robotic assistance provides intensive motor training through a large number of repetitive movements, usually oriented and interactive tasks (pointing tasks, tracking paths… Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Stroke
What is being tested?: Robot InMotion 2.0 and Conventional rehabilitation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 2 sitesFrance
Study dates: 30 Oct 2014to 11 Jul 2022
Phase: Interventional
Are there results?: None posted in the registry

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 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years;
Stroke hemiparesis on unilateral focal lesion dating from 4 to 10 weeks at baseline;
Active flexion of the paretic shoulder ≥15 °;
Average score on the modified scale of Frenchay <5;
Patient having agreed to sign an informed consent.

Who cannot join

Passive extension of the paretic elbow <120 °;
Passive extension of the paretic wrist <10 °;
Cognitive dysfunction or progressive intercurrent illness making effective communication or participation in the study impossible;
Infection, inflammation or complex regional pain syndrome of the paretic upper extremity;
Injection of botulinum toxin to the upper limb less than 3 months old;
Patient under safeguard of justice;
Patient include in an other clinical trial.

Trial locations and contacts

2 sites in 1 country.

France2 sites

Clinique Les Trois Soleils
Boissise-le-Roi, 77310
Hôpitaux Universitaires Henri Mondor
Créteil, 94010

Other trials in France

About this study

Official title: Rehabilitation Program With Robotic Assistance for the Improvement of Motor Performance and Functional Use of the Upper Limb in Subacute Hemiparetic. Multicenter Randomized Controlled Trial

Hemiparesis is the most common motor disorder after a stroke. Most patients do not recover functional use of their paretic upper limb.

The use of robotic assistance provides intensive motor training through a large number of repetitive movements, usually oriented and interactive tasks (pointing tasks, tracking paths tasks...). These feature have been demonstrated to be critical to stimulate brain plasticity after a brain damage. The InMotion Arm 2.0 manipulator works with an adaptive algorithm that provide patients with real-time Assistance-as-Needed™ desgned to enhance motor performance.

Hypothesis: In the sub-acute phase of stroke, the structured practice of a large number of repeated movements will increase motor function of the upper limb compared to conventional rehabilitation. Secondly, this practice will be more effective in a free active mode (without assistance) than an active assisted mode (Assistance-as-Needed™).

Expected secondary benefits: Subjective impression of improved use of the upper limb in activities of daily living and reduction of spastic cocontractions affecting the agonist and antagonist muscles during movements of the upper limb.

Objectives: This randomized controlled trial will evaluate the effects of structured repetition programs of arm movements, on the function of the hemiparetic upper limb and motor control, between 4 and 10 weeks after the stroke, using a robotic device with or without assistance in partial substitution of conventional rehabilitation care, compared to a program with conventional care alone.

Conditions: Stroke
Being tested: Robot InMotion 2.0, Conventional rehabilitation
Keywords: Stroke, Robot,, Rehabilitation, Hemiparesis, Upper limb, Function, Motor control
Medical subject headings: Stroke, Paresis

What participants receive

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

Robot InMotion 2.0Device
Repetitive work of large numbers of targeted alternative movements with or without assistance. The passage between with and without assistance taking place according to the evolution of performance judged by the investigator therapist. Note that the duration of the training using the assisted mode should be at least 3 weeks, i.e. half of the total duration of treatment.
Conventional rehabilitationOther
Conventional rehabilitation implemented by an occupational therapist, involving stretching movements in submaximal passive amplitude, inhibition postures (Bobath), active efforts assisted of varied difficulty, exercises of direction of the arm towards a target with or without elbow support and grasping tasks, adapted to the capacities of the paretic upper limb.

Study groups in NCT03584477
Study group	Role	What they receive
Conventional rehabilitation	Active comparator	5 sessions / week of 1 hour of occupational therapy Receives: Other: Conventional rehabilitation
Robotic rehabilitation with assistance	Active comparator	5 sessions / week of 1 hour of rehabilitation of the upper limb with 30 min of conventional rehabilitation and 30 min of robotic rehabilitation with assistance. Receives: Device: Robot InMotion 2.0; Other: Conventional rehabilitation
Non-assistance robotic rehabilitation	Active comparator	5 sessions / week of 1 hour of rehabilitation of the upper limb including 30 min of conventional rehabilitation and 30 min of robotic rehabilitation without assistance. Receives: Device: Robot InMotion 2.0; Other: Conventional rehabilitation

What is being measured

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

Functional performance score change on Modified Frenchay Scale
The scale measures active upper limb function in hemiparesis based on 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand. Final score is an average of the 10 subscores (10 is the higher score).
Measured: Between the pre-rehabilitation state on the day of program start (Day1) and the state at the end of the program (Week6)

Secondary outcomes (2)

Functional performance score change on Modified Frenchay Scale
The scale measures active upper limb function in hemiparesis based on 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand. Final score is an average of the 10 subscores (10 is the higher score).
Measured: between Day1 (day of program start) and Week22 (16 weeks after the end of the program)
Change of motor performance score on the Fugl-Meyer score
Fugl-Meyer (FM) assessment for measures of the motor impairment of the upper-limb; the test includes items related to movements of the shoulder, elbow, forearm (proximal arm), and wrist and hand (distal arm). The total scores range between 0 and 66.
Measured: between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)

Timeline

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

30 Oct 201411 Jul 2022

First posted12 Jul 2018
Study start30 Oct 2014
Primary completion22 Apr 2015
Study completion11 Jul 2022

Why it stopped: The study was stopped because inclusion rate was not met. No inclusion in the last 11 months.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Single blind
Who is masked: Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03584477
Sponsor's protocol ID: 2011-A00632-39
Acronym: ROBOASSIST
Status last verified: Feb 2023
First submitted: 19 Jun 2018
Last updated: 13 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
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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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rehabilitation Program With Robotic Assistance for the Improvement of Motor Performance and Functional Use of the Upper Limb in Subacute Hemiparetic. Multicenter Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03584477
Acronym / sponsor ID: ROBOASSIST / 2011-A00632-39
Conditions: Stroke
Keywords: Stroke, Robot,, Rehabilitation, Hemiparesis, Upper limb, Function, Motor control
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was stopped because inclusion rate was not met. No inclusion in the last 11 months.
Enrolment: 54 participants (actual)
Lead sponsor: Clinique Les Trois SoleilsUniversity, hospital or other
Collaborators: Assistance Publique - Hôpitaux de Paris
Study start: 30 Oct 2014 (actual)
Primary completion: 22 Apr 2015 (actual)
Study completion: 11 Jul 2022 (actual)
First posted: 12 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

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

Hemiparesis is the most common motor disorder after a stroke. Most patients do not recover functional use of their paretic upper limb.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Conventional rehabilitation	Active comparator	Other: Conventional rehabilitation5 sessions / week of 1 hour of occupational therapy
Robotic rehabilitation with assistance	Active comparator	Device: Robot InMotion 2.0, Other: Conventional rehabilitation5 sessions / week of 1 hour of rehabilitation of the upper limb with 30 min of conventional rehabilitation and 30 min of robotic rehabilitation with assistance.
Non-assistance robotic rehabilitation	Active comparator	Device: Robot InMotion 2.0, Other: Conventional rehabilitation5 sessions / week of 1 hour of rehabilitation of the upper limb including 30 min of conventional rehabilitation and 30 min of robotic rehabilitation without assistance.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥18 years;
Stroke hemiparesis on unilateral focal lesion dating from 4 to 10 weeks at baseline;
Active flexion of the paretic shoulder ≥15 °;
Average score on the modified scale of Frenchay <5;
Patient having agreed to sign an informed consent.

Key exclusion criteria (7 listed)

Passive extension of the paretic elbow <120 °;
Passive extension of the paretic wrist <10 °;
Cognitive dysfunction or progressive intercurrent illness making effective communication or participation in the study impossible;
Infection, inflammation or complex regional pain syndrome of the paretic upper extremity;
Injection of botulinum toxin to the upper limb less than 3 months old;

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
Robot InMotion 2.0Repetitive work of large numbers of targeted alternative movements with or without assistance. The passage between with and without assistance taking place according to the evolution of performance judged by the investigator therapist. Note that the duration of the training using the assisted mode should be at least 3 weeks, i.e. half of the total duration of treatment.	Device	Non-assistance robotic rehabilitation, Robotic rehabilitation with assistance
Conventional rehabilitationConventional rehabilitation implemented by an occupational therapist, involving stretching movements in submaximal passive amplitude, inhibition postures (Bobath), active efforts assisted of varied difficulty, exercises of direction of the arm towards a target with or without elbow support and grasping tasks, adapted to the capacities of the paretic upper limb.	Other	Conventional rehabilitation, Non-assistance robotic rehabilitation, Robotic rehabilitation with assistance

Primary outcome

Functional performance score change on Modified Frenchay Scale
Time frame: Between the pre-rehabilitation state on the day of program start (Day1) and the state at the end of the program (Week6)
The scale measures active upper limb function in hemiparesis based on 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand. Final score is an average of the 10 subscores (10 is the higher score).

2 secondary outcomes

Functional performance score change on Modified Frenchay Scale
Time frame: between Day1 (day of program start) and Week22 (16 weeks after the end of the program)
Change of motor performance score on the Fugl-Meyer score
Time frame: between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)

Results and safety

The study was stopped early (reason given: The study was stopped because inclusion rate was not met. No inclusion in the last 11 months.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
Individual participant dataSharing planned: No

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.

Christophe Duret, MD principal investigator

Clinique Les Trois Soleils

Jean-Michel Gracies, Pr principal investigator

Hôpitaux Universitaires Henri Mondor

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

Questions about this trial

What is this clinical trial studying?

A study testing Robot InMotion 2.0 and Conventional rehabilitation in people with Stroke, run by Clinique Les Trois Soleils at 2 sites in France.

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 7 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: stopped early, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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?

The study was stopped early (reason given: The study was stopped because inclusion rate was not met. No inclusion in the last 11 months.). Results are not available in the source record.

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?

Functional performance score change on Modified Frenchay Scale (time frame: Between the pre-rehabilitation state on the day of program start (Day1) and the state at the end of the program (Week6)). 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 NCT03584477.

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 13 Feb 2023.