Robotic Rehabilitation of the Upper Limb After a Stroke

NCT03584477 | Terminated

• 1 other identifier: 2011-A00632-39
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Functional performance score change on Modified Frenchay Scale

  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

  between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)

Other Outcomes (6)

• Change in perceived function score on the Disability Assessment Scale (DAS)

  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)

  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

  at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)

Study Arms (3)

Conventional rehabilitation

ACTIVE COMPARATOR

5 sessions / week of 1 hour of occupational therapy

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.

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.

Device: Robot InMotion 2.0; Other: Conventional rehabilitation

Interventions

Robot InMotion 2.0 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.

Non-assistance robotic rehabilitation; Robotic rehabilitation with assistance

Conventional rehabilitation 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.

Conventional rehabilitation; Non-assistance robotic rehabilitation; Robotic rehabilitation with assistance

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Les Trois Soleils: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (2)

Clinique Les Trois Soleils

Boissise-le-Roi, 77310, France

Location

Hôpitaux Universitaires Henri Mondor

Créteil, 94010, France

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christophe Duret, MD

  Clinique Les Trois Soleils

  PRINCIPAL INVESTIGATOR

• Jean-Michel Gracies, Pr

  Hôpitaux Universitaires Henri Mondor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 12, 2018
• Study Start: October 30, 2014
• Primary Completion: April 22, 2015
• Study Completion: July 11, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)