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

NCT02267798 | Completed DMC

• 1 other identifier: Regionale WP1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke; Arm Motor Recovery

Keywords

Stroke; Rehabilitation; Arm motor recovery; biological biomarkers

Outcome Measures

Primary Outcomes (1)

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

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

  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.

Secondary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

arm training combined with FES

EXPERIMENTAL

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.

Device: arm training combined with FES

conventional therapy

ACTIVE COMPARATOR

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.

Other: conventional therapy

Interventions

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.

conventional therapy

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.

arm training combined with FES

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (2)

Physical Medicine and Rehabilitation Department Ferrara

Ferrara, Emilia-Romagna, 44100, Italy

Location

Ferrara University Hospital

Ferrara, Ferrara, 44124, Italy

Location

Related Publications (1)

• Straudi S, Baroni A, Mele S, Craighero L, Manfredini F, Lamberti N, Maietti E, Basaglia N. Effects of a Robot-Assisted Arm Training Plus Hand Functional Electrical Stimulation on Recovery After Stroke: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2020 Feb;101(2):309-316. doi: 10.1016/j.apmr.2019.09.016. Epub 2019 Nov 1.

  PMID: 31678222 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nino Basaglia, MD

  Ferrara University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: October 20, 2014
• Study Start: September 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)