Robotic Rehabilitation of the Upper Limb After a Stroke

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Other: Conventional rehabilitation; Device: Robot InMotion 2.0

• Registration Number: NCT03584477
• Lead Sponsor: Clinique Les Trois Soleils

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 available

Study Timeline

• Study Start: 2014-10-30
• Primary Completion: 2015-04-22
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-12
• Study Completion: 2022-07-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional rehabilitation	Conventional rehabilitation	5 sessions / week of 1 hour of occupational therapy
Non-assistance robotic rehabilitation	Conventional 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.
Robotic rehabilitation with assistance	Robot InMotion 2.0	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.
Robotic rehabilitation with assistance	Conventional rehabilitation	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.
Non-assistance robotic rehabilitation	Robot InMotion 2.0	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.

Primary Outcome Measures

Name	Time	Method
Functional performance score change on Modified Frenchay Scale	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

Name	Time	Method
Functional performance score change on Modified Frenchay Scale	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	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.

Trial Locations

Locations (2)

Clinique Les Trois Soleils; 🇫🇷 Boissise-le-Roi, France

Hôpitaux Universitaires Henri Mondor; 🇫🇷 Créteil, France