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Completed

NCT Number: NCT02267798

Repetitive Arm Training + FES on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors

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.

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Key information

Conditions

Stroke Arm Motor Recovery Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Medicine and Rehabilitation Department Ferrara, Ferrara, Emilia-Romagna, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • males and females, age 18 to 79 years
  • diagnosis of first, single unilateral ischemic stroke verified by brain imaging < 8 weeks
  • upper limb motor function defined by an FM-UE score > 11 and <55

Exclusion criteria

  • medical conditions likely to interfere with the ability to safely complete the study protocol
  • impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
  • severe upper-limb pain, referred as > 7 at Visual Analog Scale (VAS)
  • history of seizures or epilepsy

Treatment and study plan

Conventional Therapy

Other

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 training combined with FES

Device

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.

Primary outcomes

  1. Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)

    Time frame: 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.

    Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.

Secondary outcomes

  1. Wolf Motor Function Test (WMFT) Manual

    Time frame: 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

  2. Modified Ashworth Scale (MAS)for spasticity measure

    Time frame: 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

    MAS: a 6-point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist

  3. Motor Activity Log (MAL)measures change in arm use during activities of daily living

    Time frame: 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

    Motor Activity Log (MAL): assessment of the change in real-world arm use in activities of daily living. Subjects are asked to score the quality of movement as well as amount of use of the affected arm in a number of common daily activities

  4. Functional Independence Measure (FIM)

    Time frame: 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

    FIM measures level of independence during activities of daily living.

  5. Stroke Impact Scale 3.0 (SIS)

    Time frame: 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

    Assesses health status following stroke

  6. Box and Block test

    Time frame: 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

    It counts the number of blocks that can be transported from one compartment of a box to another compartment within 1 min.

  7. Motor cortex excitability (single pulse and paired pulse TMS)

    Time frame: 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

    • Single pulse TMS Single-Pulse TMS will be used to study cortical-spinal tract excitability in primary motor cortex (M1).
    • Paired-pulse TMS Paired-Pulse TMS will be used to study intracortical excitability.

  8. Analysis of muscle activation patterns during upper extremity movements

    Time frame: 1) One week prior to treatment initiation 2) the week after the end of treatment 3) at 6 months follow-up

    A measure of the coordination of muscular activity across muscles of the upper limbs will be derived from recordings performed during a series of upper extremity motor tasks.

  9. NIRS (Near Infrared Spectroscopy)

    Time frame: 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

    For the NIRS it will use an 32-channel NIRS imaging equipment which consist of 16 pairs of emitting and detecting optical fibers attached to a custom-made head cap placed on primary motor cortex.

    NIRS measurements will be performed during 6 cycles of 15s hand reaching and grasping and 45s resting while sitting on a chair.

  10. Circulating Biomarkers

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2014
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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