Robotic Rehabilitation of the Upper Limb After a Stroke (ROBOASSIST)

• ClinicalTrials.gov Identifier: NCT03584477
• Recruitment Status: Recruiting
• First Posted: July 12, 2018
• Last Update Posted: March 10, 2022
• Sponsor: Clinique Les Trois Soleils
• Collaborator: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Clinique Les Trois Soleils

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Stroke	Device: Robot InMotion 2.0; Other: Conventional rehabilitation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: October 30, 2014
• Estimated Primary Completion Date: March 15, 2022
• Estimated Study Completion Date: April 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Conventional rehabilitation; 5 sessions / week of 1 hour of occupational therapy	Other: Conventional rehabilitation; 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.
Active Comparator: Robotic rehabilitation with assistance; 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.	Device: Robot InMotion 2.0; 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.; Other: Conventional rehabilitation; 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.
Active Comparator: Non-assistance robotic rehabilitation; 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.	Device: Robot InMotion 2.0; 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.; Other: Conventional rehabilitation; 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.

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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) ]
   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. 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) ]
   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.

Other Outcome Measures:

1. Change in perceived function score on the Disability Assessment Scale (DAS) [ Time Frame: between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) ]
   The scale evaluates upper limb functional disability in patients with spasticity following stroke. Patients are interviewed to determine the extent of functional impairment for the following 4 areas: hygiene,dressing, limb position, pain.The DAS Scale uses a 4-point rating scale according to the following criteria: 0(no disability),1 (mild disability), 2 (moderate disability) and 3(severe disability).
2. Change in perceived function score on the Global Subjective Self Assessment (GSSA) [ Time Frame: between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) ]
   Three questions were asked to the patient, relating to pain, stiffness-induced discomfort and active function. Each rating was registered by the patient using a visual analogue scale ranging from 0 (worst pain imaginable, worst discomfort imaginable, arm totally useless, respectively) to 10 (no pain, no stiffness-induced discomfort, normal function, respectively).
3. Angle and grade of spasticity of the shoulder extensors, flexors and elbow pronators, clinically measured by the Tardieu modified scale [ Time Frame: at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) ]
   The scale is a clinical measure of muscle spasticity for use with patients with neurological conditions. Spasticity is quantified by assessing the muscle's response to stretch applied at given velocities.
4. Paresis angle of shoulder flexion, extension and supination of the elbow; [ Time Frame: at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) ]
   Paresis angle of shoulder flexion (maximal passive amplitude - maximal active amplitude)
5. Kinematic data of the movements based on the robot's records [ Time Frame: at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) ]
6. Maximum motor force measured by the robot of the abductor/adductor and flexors/extensors of the shoulder [ Time Frame: at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Contacts

Contact: Christophe Duret, MD; ch.duret@les-trois-soleils.fr

Locations

France

Clinique Les Trois Soleils; Recruiting

Boissise-le-Roi, France, 77310

Contact: Christophe Duret, MD ch.duret@les-trois-soleils.fr

Principal Investigator: Christophe Duret, MD

Hôpitaux Universitaires Henri Mondor; Active, not recruiting

Créteil, France, 94010

Sponsors and Collaborators

Clinique Les Trois Soleils

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Christophe Duret, MD; Clinique Les Trois Soleils
• Principal Investigator: Jean-Michel Gracies, Pr; Hôpitaux Universitaires Henri Mondor

More Information

• Responsible Party: Clinique Les Trois Soleils
• ClinicalTrials.gov Identifier: NCT03584477
• Other Study ID Numbers: 2011-A00632-39
• First Posted: July 12, 2018
• Last Update Posted: March 10, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clinique Les Trois Soleils:

Stroke; Robot,; Rehabilitation; Hemiparesis; Upper limb; Function; Motor control

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases