Multi-segmental Robotic and Technological Upper Limb Rehabilitation in Stroke

NCT02879279 | Completed

• 1 other identifier: FDG_MUR
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is frequently associated with significant disability and impaired quality of life. Persistent motor impairment is common with often incomplete recovery of motor function in response to rehabilitation, mainly in the upper limbs. Robot-mediated therapy has been proposed as a viable approach for the rehabilitation of the upper limb, but as the evidence quality is low, more rigorous studies are needed. Previous studies have focused on the effects of devices acting on a limited number of joints, often limiting the workspace on a plane. This study aims to evaluate the efficacy of a multi-set of robotic and technological devices for the rehabilitation of the upper limb in sub-acute stroke patients.

Conditions

Stroke

Keywords

Stroke; Upper limb; Robotic rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Fugl-Meyer Assessment of Motor Recovery after Stroke (Upper Extremity portion)

  The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation and joint functioning in patients with post-stroke hemiplegia

  Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2)

Secondary Outcomes (9)

• Change from Baseline Motricity Index

  Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2)

• Change from Baseline British Medical Research Council Scale (Shoulder, Elbow and Wrist)

  Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2)

• Change from Baseline Modified Ashworth Scale (Shoulder, Elbow and Wrist)

  Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2)

• Change from Baseline Frenchay Activities Index

  Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2)

• Change from Baseline Action Research Arm Test

  Patients will be evaluated at baseline (T0), at the end of each rehabilitation program (T1), lasting 6 weeks, and 3 months after the end the treatment (T2)

Study Arms (2)

Robotic rehabilitation

EXPERIMENTAL

In the robotic rehabilitation group, both the distal and the proximal parts of the patients' upper arm will be treated by means of a multi-set of robotic and technological devices, i.e, Amadeo, Pablo, Diego and Motore. The aforementioned systems can be used to perform three-dimensional movements of the shoulder, planar movements of the shoulder and elbow, prono-supination movements of the forearm, flexion-extension movements of the wrist, bimanual movements, and flexion/extension movements of the fingers. A vibratory treatment will be applied, using the Amadeo, to increase the proprioception of the hand. Motor and cognitive tasks, comprising active, passive and active-assistive, will be performed during the treatment. Visual and auditory feedback will be provided to help the patients.

Device: Amadeo, Pablo, Diego and Motore.

Conventional rehabilitation

ACTIVE COMPARATOR

In the conventional rehabilitation group, patients will undergo a conventional treatment. The therapeutic tasks will focus on sensorimotor reprogramming, hypertonus inhibition, functional improvement, including task-oriented exercises. Specifically, patients will perform passive, active and active assisted exercises on the three upper limb joints, to improve joint function, to prevent contractures, to inhibit hypertonus and to improve trophism and motor function.

Other: Conventional rehabilitation

Interventions

Amadeo, Pablo, Diego and Motore. DEVICE

In the robotic rehabilitation group, patients will be treated with the following systems: Amadeo, Pablo and Diego (Tyromotion GmbH, Austria), and Motore (Humanware, Italy). A ratio of one therapist to every 3 or 4 patients will be used, depending on the patient's severity. The rehabilitation treatment will be performed daily for 45 minutes, for 5 days per week, for 6 weeks. A total of 30 sessions will be performed.

Robotic rehabilitation

Conventional rehabilitation OTHER

In the conventional rehabilitation group, patients will undergo a conventional treatment with a ratio of one therapist to one patient. The rehabilitation treatment will be performed daily for 45 minutes, for 5 days per week, for 6 weeks. A total of 30 sessions will be performed.

Conventional rehabilitation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute or sub-acute patients, with ischemic and hemorrhagic stroke, verified by MRI or CT
• Age between 40 and 80 years;
• Time latency since stroke ranging from two weeks to six months
• Cognitive and language abilities that are sufficient to understand the experiments and follow instructions

You may not qualify if:

• Behavioral and cognitive disorders and/or reduced compliance that would interfere with active therapy;
• Fixed contraction deformity in the affected limb that would interfere with active therapy (ankylosis, Modified Ashworth Scale = 4);
• Severe deficits in visual acuity;
• Upper extremity Fugl-Meyer score \>58.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Don Gnocchi Foundation

Rome, 00168, Italy

Location

Related Publications (7)

• Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2015 Nov 7;2015(11):CD006876. doi: 10.1002/14651858.CD006876.pub4.

  PMID: 26559225 BACKGROUND

• Kwakkel G, Kollen BJ, Krebs HI. Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):111-21. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.

  PMID: 17876068 BACKGROUND

• Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.

  PMID: 25387001 BACKGROUND

• Norouzi-Gheidari N, Archambault PS, Fung J. Effects of robot-assisted therapy on stroke rehabilitation in upper limbs: systematic review and meta-analysis of the literature. J Rehabil Res Dev. 2012;49(4):479-96. doi: 10.1682/jrrd.2010.10.0210.

  PMID: 22773253 BACKGROUND

• Cecchi F, Germanotta M, Macchi C, Montesano A, Galeri S, Diverio M, Falsini C, Martini M, Mosca R, Langone E, Papadopoulou D, Carrozza MC, Aprile I. Age is negatively associated with upper limb recovery after conventional but not robotic rehabilitation in patients with stroke: a secondary analysis of a randomized-controlled trial. J Neurol. 2021 Feb;268(2):474-483. doi: 10.1007/s00415-020-10143-8. Epub 2020 Aug 25.

  PMID: 32844309 DERIVED

• Aprile I, Germanotta M, Cruciani A, Loreti S, Pecchioli C, Cecchi F, Montesano A, Galeri S, Diverio M, Falsini C, Speranza G, Langone E, Papadopoulou D, Padua L, Carrozza MC; FDG Robotic Rehabilitation Group. Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial. J Neurol Phys Ther. 2020 Jan;44(1):3-14. doi: 10.1097/NPT.0000000000000295.

  PMID: 31834217 DERIVED

• Germanotta M, Cruciani A, Pecchioli C, Loreti S, Spedicato A, Meotti M, Mosca R, Speranza G, Cecchi F, Giannarelli G, Padua L, Aprile I. Reliability, validity and discriminant ability of the instrumental indices provided by a novel planar robotic device for upper limb rehabilitation. J Neuroeng Rehabil. 2018 May 16;15(1):39. doi: 10.1186/s12984-018-0385-8.

  PMID: 29769127 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

• Irene Aprile, MD, PhD

  Don Gnocchi Foundation

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 25, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)