Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02721212
Recruitment Status : Unknown
Verified March 2016 by Giovanni Taveggia, Habilita S.p.A..
Recruitment status was:  Not yet recruiting
First Posted : March 29, 2016
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Giovanni Taveggia, Habilita S.p.A.

Brief 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).

Condition or disease Intervention/treatment Phase
Stroke Device: Armeo Spring Other: Conventional Rehabilitation Not Applicable

Detailed Description:
Authors conducted a double blind randomized controlled trial. Informed consent was obtained from all participants and procedures were conducted according to the Declaration of Helsinki. The protocol (N° U0074917/11110) was approved by the Local Ethical Committee of Bergamo, Italy. A number of clinical trials have shown significant advances in upper limb recovery with the use of different sensory - motor techniques, including intensive repetitive movement, constraint-induced movement therapy, functional electrical stimulation treatment, the use of robot-assisted therapy in association with virtual reality. Robot-assisted virtual reality intervention has been shown more effective than conventional interventions and achieved more improvement in upper limb function, however the effect size reported by recent reviews was small and this datum is always reported as a cost-benefit ratio to challenge the use of virtual reality technology in rehabilitation. Robot aided rehabilitation is increasingly used in stroke rehabilitation, with a broad spectrum of applied technology from motor to non-motor aided systems, posing the problem to match the clinical need of the patient with the proper device. In the immediate post stroke period the motor recovery usually do not allow the use of non-motored robot device while the use of motored robot aid after months can be too delayed to obtain some valuable clinical results. The wide range of available devices are certainly a richness in the clinical possibility but also a critical factor in selecting a suitable technology tailored for the clinical feature of the patient at the actual state of the art. This can affect the comparison and interpretation of the literature so far published. Virtual reality therapy recreates favorable conditions to motor learning. Functional recovery is achieved through use-dependent cortical reorganization. The time/intensity of its application is therefore a pivotal point in this learning process. Its duration is not standardized and can varies from 3-4 to 20 hours of total treatment making results accordingly variable, adding further bias in data interpretation. A prerequisite to gain the best results is patients selection and early application when is possible.All these factors, have been ascribed as possible causes of small effect size reported in recent literature in comparing robot-aided virtual reality rehabilitation versus traditional rehabilitation alone.In a group of patients with hemiparesis following stroke, we compared the efficacy of a neurorehabilitation program consist of combination of non-motor robot-assisted therapy with virtual reality (Armeo®Spring) to conventional therapy with the primary aim to verify if the punctual application of what suggested by the single papers is able to improve differences of the efficacy between treatments and, therefore, creating a better effect size. And, as a secondary arm, if it is possible to improve the clinical picture also in post-acute stroke patients and as a secondary aim, if motor selection and intensive treatments can improve the small effect size reported by the literature.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of a New Technology to Functional Recovery Upper Limb in Post Stroke Patients: a Randomized Controlled Study
Study Start Date : March 2016
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: 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.

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.


Active Comparator: Control Group

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.

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.





Primary Outcome Measures :
  1. Change in Functional Independence Measure - FIM [ Time Frame: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2) ]
    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). Investigators assessed the impact on functional recovery (Functional Independence Measure - FIM scale).

  2. Change in strength (ARM Motricity Index-MI) [ Time Frame: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2) ]
    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). Investigators assessed the impact on strength (ARM Motricity Index-MI)


Secondary Outcome Measures :
  1. Change in spasticity (Modified Ashworth Scale-MAS) [ Time Frame: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2) ]
    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). Investigators assessed the impact on spasticity (Modified Ashworth Scale-MAS)

  2. Change in pain (Numeric Rating Pain Scale -NRPS) [ Time Frame: From baseline (T0) to 6 weeks (T1) and 12 weeks (T2) ]
    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). Investigators assessed the impact on pain (Numeric Rating Pain Scale -NRPS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The clinical diagnosis of stroke
  • post stroke hemiparesis
  • maximum six months from stroke
  • stability of the clinical picture at the time of roll-in
  • minimum level of upper arm motility (>2) movement against gravity
  • trunk control and ability to maintain sitting position for at least 120 minutes

Exclusion Criteria:

  • Hemiplegia of other aetiology ( neurodegenerative, neoplastic)
  • Presence of articular ankyloses, spasms and/or severe muscle spasticity with complete loss of movement in any of the three major joints
  • Instability of upper limb bone (not consolidated fractures)
  • Presence of cognitive impairment (MMSE<=21) and/or psychiatric disease
  • Concomitant disease that could prevent the rehabilitation program (respiratory failure, heart failure, osteomyelitis, thrombophlebitis and other clinical condition that are against rehabilitation treatment)
  • Ulcer sores that can contraindicate the use to ARMEO Spring
  • Ashworth > 3 (for each of the three upper limb joints)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721212


Contacts
Layout table for location contacts
Contact: Lorena Salvi, Vice Coord. +39035918 ext 293 salvi.lorena@gmail.com
Contact: Chiara Mulè, Coordinator +39035918 ext 293 chiaramule@habilita.it

Locations
Layout table for location information
Italy
Habilita, Sarnico's Hospital
Sarnico, Bergamo, Italy, 24067
Contact: Giovanni Taveggia, MD    +39035918 ext 293    giovannitaveggia@habilitasarnico.it   
Sub-Investigator: Chiara Mulè, MD         
Sub-Investigator: Stefania Fogliaresi, PT         
Sub-Investigator: Lorena Salvi, PT         
Sub-Investigator: Alberto Borboni, PhD, Eng         
Sub-Investigator: Roberto Casale, MD         
Principal Investigator: Giovanni Taveggia, MD         
Sponsors and Collaborators
Habilita S.p.A.
Investigators
Layout table for investigator information
Principal Investigator: Giovanni Taveggia, MD Habilita S.p.A.
Study Director: Roberto Casale, MD Habilita S.p.A.
Publications of Results:

Layout table for additonal information
Responsible Party: Giovanni Taveggia, MD, Habilita S.p.A.
ClinicalTrials.gov Identifier: NCT02721212    
Other Study ID Numbers: Habilita-Armeo-01
U0074917/11110 ( Other Identifier: Bioethic board )
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Giovanni Taveggia, Habilita S.p.A.:
Robotic
Stroke
Upper Limb Rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases