Upper Limb Training Modalities in Patients With Stroke

NCT03590314 | Completed DMC

• 1 other identifier: UPPER-Trial
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Stroke

Keywords

Stroke; Upper limb; Recovery

Outcome Measures

Primary Outcomes (1)

• Fugl Meyer Upper Limb Assessment scale

  Evaluate functional improvements of upper limbs

  Up to six weeks

Secondary Outcomes (4)

• Modified Ashworth Scale

  Up to six weeks

• Medical Research Council Scale

  Up to six weeks

• Active Range of Motion

  Up to six weeks

• UL electromyographic analysis of muscle activation

  Up to six weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group was treated using a robot assisted arm training, Armotion (Reha Technology, Olten, Switzerland).

Device: Experimental group - robot assisted arm training (Armotion®)

Control group

ACTIVE COMPARATOR

The control group was treated using a conventional training, without end effector robot.

Other: Control group - conventional treatment

Interventions

Experimental group - robot assisted arm training (Armotion®) DEVICE

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.

Also known as: Robot assisted treatment (Armotion®)

Experimental group

Control group - conventional treatment OTHER

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.

Also known as: Conventional treatment

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years;
• diagnosis of ischemic or hemorrhagic first-ever stroke as documented by a computerized tomography scan or magnetic resonance imaging;
• at least 6 months since stroke;
• Modified Ashworth Scale (MAS) score (shoulder and elbow) ≤ 3 and ≥1+;
• BoNT injection within the previous 12 weeks of at least one of muscles of the affected upper limb;
• Mini-Mental State Examination (MMSE) score ≥24
• Trunk Control Test score = 100/100.

You may not qualify if:

• any type of rehabilitation intervention in the 3 months prior to recruitment;
• bilateral cerebrovascular lesion;
• severe neuropsychologic impairment (global aphasia, severe attention deficit or neglect);
• concomitant orthopedic disorders.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Verona, Italy, Verona, 37134, Italy

Location

Related Publications (1)

• Gandolfi M, Vale N, Dimitrova EK, Mazzoleni S, Battini E, Filippetti M, Picelli A, Santamato A, Gravina M, Saltuari L, Smania N. Effectiveness of Robot-Assisted Upper Limb Training on Spasticity, Function and Muscle Activity in Chronic Stroke Patients Treated With Botulinum Toxin: A Randomized Single-Blinded Controlled Trial. Front Neurol. 2019 Jan 31;10:41. doi: 10.3389/fneur.2019.00041. eCollection 2019.

  PMID: 30766508 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

• Nicola Smania, Professor

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single-blind RCT with two parallel group

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 18, 2018
• Study Start: January 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: July 1, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

IT (1)