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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Other: Conventional rehabilitation; Device: Robot InMotion 2.0

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.	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.; 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.
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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Between the pre-rehabilitation state on the day of program start (Day1) and the state at the end of the program (Week6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived function score on the Disability Assessment Scale (DAS)	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).	between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)
Change in perceived function score on the Global Subjective Self Assessment (GSSA)	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).	between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)
Angle and grade of spasticity of the shoulder extensors, flexors and elbow pronators, clinically measured by the Tardieu modified scale	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.	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, extension and supination of the elbow;	Paresis angle of shoulder flexion (maximal passive amplitude - maximal active amplitude)	at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)
Kinematic data of the movements based on the robot's records		at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)
Maximum motor force measured by the robot of the abductor/adductor and flexors/extensors of the shoulder		at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)

Collaborators and Investigators

• Sponsor: Clinique Les Trois Soleils
• Collaborators: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2014
• Primary Completion (ACTUAL): April 22, 2015
• Study Completion (ACTUAL): July 11, 2022

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (ACTUAL): July 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Upper limb; Function; Motor control; Hemiparesis; Robot,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2011-A00632-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No