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Impact of a New Technology to Functional Recovery Upper Limb in Post Stroke Patients.

NCT02721212 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-03-29

No results posted yet for this study

Summary

54 inpatients participants were randomly divided into two groups (experimental and conventional). Individual of experimental group were treated according to an established protocol for ARMEO Spring (30 minutes/session with "Armeo Spring" and 30 minutes/session with conventional treatment 5 days/week for 6 weeks). The conventional treatment consists of passive and active assisted mobilization of the upper limbs, traditional training based on the Bobath concept. Inpatients of control group were treated with conventional treatment with training session of 60 minutes 5 days/week for 6 weeks. All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow up 6 weeks later (T2). We assessed the impact on functional recovery (Functional Independence Measure - FIM scale), strength (ARM Motricity Index-MI), spasticity (Modified Ashworth Scale-MAS) and pain (Numeric Rating Pain Scale -NRPS).

Conditions

Interventions

DEVICE

Armeo Spring

All patients of experimental group were treated according to an established protocol for ARMEO Spring. In the first session the device was adjusted for patients arms. The physiotherapist controlled functional space of upper limb movement and correct position of working station. Each training session consisted of two parts with 30 minutes per session with "Armeo Spring" and 30 minutes per session with conventional treatment 5 days per week, for 6 weeks.

OTHER

Conventional Rehabilitation

The conventional treatment, under control of physiotherapist, consists of passive and active assisted mobilization of the upper limbs traditional training based on the Bobath concept (neuromuscular facilitation, postural control and proprioception exercises, verticalization and gait training). Each training session consisted of 60 minutes with conventional treatment 5 days per week, for 6 weeks in a control group. The conventional session in the experimental group lasted 30 minutes with the same techniques and methods.

Sponsors & Collaborators

  • Habilita S.p.A.

    lead OTHER

Principal Investigators

  • Giovanni Taveggia, MD · Habilita S.p.A.

  • Roberto Casale, MD · Habilita S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

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 NCT02721212 on ClinicalTrials.gov