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

NCT02721212 | Unknown DMC

• 2 other identifiers: Habilita-Armeo-01U0074917/11110
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Keywords

Robotic; Stroke; Upper Limb Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change in Functional Independence Measure - FIM

  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).

  From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)

• Change in strength (ARM Motricity Index-MI)

  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)

  From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)

Secondary Outcomes (2)

• Change in spasticity (Modified Ashworth Scale-MAS)

  From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)

• Change in pain (Numeric Rating Pain Scale -NRPS)

  From baseline (T0) to 6 weeks (T1) and 12 weeks (T2)

Study Arms (2)

Armeo Spring

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Armeo Spring DEVICE

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.

Armeo Spring

Conventional Rehabilitation OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Habilita S.p.A.: lead

Study Sites (1)

Habilita, Sarnico's Hospital

Sarnico, Bergamo, 24067, Italy

Location

Related Publications (33)

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Giovanni Taveggia, MD

  Habilita S.p.A.

  PRINCIPAL INVESTIGATOR

• Roberto Casale, MD

  Habilita S.p.A.

  STUDY DIRECTOR

Central Study Contacts

Lorena Salvi, Vice Coord.

CONTACT

+39035918; salvi.lorena@gmail.com

Chiara Mulè, Coordinator

CONTACT

+39035918; chiaramule@habilita.it

Study Design

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

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 29, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 29, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)