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

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ClinicalTrials.gov Identifier: NCT03584477
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Clinique Les Trois Soleils

Tracking Information
First Submitted Date  ICMJE June 19, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date July 26, 2019
Actual Study Start Date  ICMJE October 30, 2014
Estimated Primary Completion Date March 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03584477 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2018)
  • 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).
  • 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).
  • 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.
  • 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)
  • 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) ]
  • 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) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Robotic Rehabilitation of the Upper Limb After a Stroke
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Conventional rehabilitation
    5 sessions / week of 1 hour of occupational therapy
    Intervention: Other: Conventional rehabilitation
  • 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.
    Interventions:
    • Device: Robot InMotion 2.0
    • Other: Conventional rehabilitation
  • 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.
    Interventions:
    • Device: Robot InMotion 2.0
    • Other: Conventional rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
57
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date March 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christophe Duret, MD ch.duret@les-trois-soleils.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584477
Other Study ID Numbers  ICMJE 2011-A00632-39
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Clinique Les Trois Soleils
Study Sponsor  ICMJE Clinique Les Trois Soleils
Collaborators  ICMJE Assistance Publique - Hôpitaux de Paris
Investigators  ICMJE
Principal Investigator: Christophe Duret, MD Clinique Les Trois Soleils
Principal Investigator: Jean-Michel Gracies, Pr Hôpitaux Universitaires Henri Mondor
PRS Account Clinique Les Trois Soleils
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP