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Upper Limb Training Modalities in Patients With Stroke

NCT03590314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-07-18

No results posted yet for this study

Summary

To date, evidence of the effects of robotic training combined with OnabotulinumtoxinA focal treatment for spasticity is limited. The objective of this study were to compare the effects of robotic training against conventional rehabilitation on functional recovery, strength and spasticity, in stroke patients who underwent OnabotulinumtoxinA focal treatment for spasticity. We performed a single-blind, randomized, controlled trial involving 24 outpatients with diagnoses of stroke, divided in two groups (experimental and control group). Experimental group received specific robotic training for the upper limb with the device Armotion/Motore (Reha Technology AG, Olten, Switzerland). Our primary outcome was Fugl-Meyer Assessment Motor Scale (FMA). Secondary outcome were Action Research Arm Test (ARAT), Modified Ashworth Scale (MAS), Medical Research Council Scale (MRC) and surface Electromyography (EMG). 14 healthy age-matched controls underwent one session of sEMG acquisition to collect normative data.

Conditions

Interventions

DEVICE

Experimental group - robot assisted arm training (Armotion®)

Passive mobilization and stretching exercises for affected upper limb (10 minutes) followed by robot-assisted exercises (35 minutes). Were selected four types of exercises contained within the Armotion® software: * "Collect the coins" * "Drive the car" * "Wash the dishes" * "Burst the balloons" For increment the difficulty, we have varied the assisted and non-assisted modality, increasing the number of repetitions over the study period.

OTHER

Control group - conventional treatment

Upper limb passive mobilization and stretching (10 minutes) followed by exercises (35 minutes) that incorporated single or multi-joints movements for the scapula, shoulder and elbow, performed in different positions (i.e. supine and standing position). The increase of difficulty and progression of intensity were obtained by increasing ROM, repetitions and performing movements against gravity or against slight resistance.

Sponsors & Collaborators

  • Universita di Verona

    lead OTHER

Principal Investigators

  • Nicola Smania, Professor · Universita di Verona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-11-30
Completion
2018-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03590314 on ClinicalTrials.gov