Repetitive Arm Training Combined With Functional Electrical Stimulation on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors

Recruiting

Phase 2 Results N/A

Trial Description

Rehabilitation restores functions and reduces disabilities due to diseases sequelae. The relationship between intensity of rehabilitation and clinical outcomes, recently emphasized, has generated a great interest for technological high-intensity interventions. However, their effects compared to traditional interventions as well the involved biological mechanisms remain uncertain. The present Strategic Program aims to predict the treatment efficacy in specific rehabilitation profiles, to improve the use of "targeted" therapies and the individual management of patients affected by stroke and to transfer these findings into rehabilitative strategies.

Detailed Description

Primary endpoint: Fugl-Meyer Upper Extremity (FM-UE) Secondary endpoints: Box and Block Test (BBT), Modified Ashworth Scale (MAS); motor cortex excitability (TMS); Electromyography analysis of muscle activation patterns during upper extremity movements; measurements of cerebral perfusion (NIRS); circulating biomarkers (see Figure 3 and Table 1). Overall assessments will be performed pre-, mid-, post-treatment and at 6-months follow-up.

Conditions

Interventions

  • Conventional therapy Other
    Intervention Desc: The conventional rehabilitation program will consist of physiotherapy sessions (100 min/day) following an individualized approach. The program aims at the restoration of mobility and daily living competence. Specific exercises for the affected upper limb will include, bilateral tasks and facilitation techniques. The amount of treatment will to be comparable between control and experimental groups in order to avoid possible confounding factors.
    ARM 1: Kind: Experimental
    Label: conventional therapy
    Description: The conventional rehabilitation program will consist of physiotherapy sessions (100 min/day) following an individualized approach. The program aims at the restoration of mobility and daily living competence, Specific exercises for the affected upper limb will include, bilateral tasks and facilitation techniques based on neuro-developmental treatment.
  • Arm training combined with FES Device
    Intervention Desc: Arm training protocol Training sessions will last for 60 minutes. The Reo Therapy System is robot-assisted therapy; during the session the subject's affected hand is placed on or strapped onto a robotic arm and the subject is instructed to either actively reach predefined reach points, or to be guided while the robotic arm leads the arm towards these reach points. Functional electrical stimulation protocol Experimental group will receive up to 40 minutes of FES after arm training. The device consists is a stimulator containing 5 electrodes positioned to provide reliable activation of the following muscles: extensor digitatum communis and extensor pollices brevis, flexor pollices longus, flexor digitatum superficialis, and thenar muscles.
    ARM 1: Kind: Experimental
    Label: arm training combined with FES
    Description: Arm training protocol Training sessions will last for 60 minutes and will focus on repetitive tasks that incorporate multidirectional reaching actions. In this robot-assisted therapy a robot manipulator applies forces to the paretic arm during goal-directed movements. Functional electrical stimulation protocol Experimental group will receive up to 40 minutes of FES after arm training. The device consists of a battery powered programmable stimulator and a forearm-wrist-hand orthosis containing 5 electrodes positioned to provide reliable activation of muscles. The intensity of stimulation will be set to a level that provided comfortable and consistent activation of the extensor and flexor muscles to achieve whole hand opening and functional grasping.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE) 1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up. No
Secondary Wolf Motor Function Test (WMFT) Manual 1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up No
Secondary Modified Ashworth Scale (MAS)for spasticity measure 1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up No
Secondary Motor Activity Log (MAL)measures change in arm use during activities of daily living 1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up No
Secondary Functional Independence Measure (FIM) 1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up No
Secondary Stroke Impact Scale 3.0 (SIS) 1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up No
Secondary Box and Block test 1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up No
Secondary Motor cortex excitability (single pulse and paired pulse TMS) 1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up No
Secondary Analysis of muscle activation patterns during upper extremity movements 1) One week prior to treatment initiation 2) the week after the end of treatment 3) at 6 months follow-up No
Secondary NIRS (Near Infrared Spectroscopy) 1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up No
Secondary Circulating Biomarkers 1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up No

Sponsors