Robotic Rehabilitation of the Upper Limb After a Stroke

NCT ID: NCT03584477

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-30
• Study Completion Date: 2022-07-11

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional rehabilitation

5 sessions / week of 1 hour of occupational therapy

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Robot InMotion 2.0

Intervention Type: DEVICE

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 rehabilitation

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Robot InMotion 2.0

Intervention Type: DEVICE

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 rehabilitation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Clinique Les Trois Soleils

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Duret, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Les Trois Soleils

Jean-Michel Gracies, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires Henri Mondor

Locations

Clinique Les Trois Soleils

Boissise-le-Roi, , France

Hôpitaux Universitaires Henri Mondor

Créteil, , France

Countries

France

Other Identifiers

2011-A00632-39

Identifier Type: -

Identifier Source: org_study_id