Stroke Clinical Trial
Official title:
Combined Robot-assisted Upper Limb Training and Botulinum Toxin Treatment for Upper Limb Function and Spasticity: a Randomized Controlled Single-blinded Trial in 32 Chronic Stroke Patients.
NCT number | NCT03590314 |
Other study ID # | UPPER-Trial |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | July 2018 |
Verified date | July 2018 |
Source | Universita di Verona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | July 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Azienta Ospedaliera, SSO Rehabilitation Unit, Verona | Verona | Italy, Verona |
Lead Sponsor | Collaborator |
---|---|
Universita di Verona |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fugl Meyer Upper Limb Assessment scale | Evaluate functional improvements of upper limbs | Up to six weeks | |
Secondary | Modified Ashworth Scale | Evaluate upper limb spasticity | Up to six weeks | |
Secondary | Medical Research Council Scale | Evaluate the muscle strength | Up to six weeks | |
Secondary | Active Range of Motion | Measure in degrees through a goniometer the shoulder, elbow and wrist joints active range of motion | Up to six weeks | |
Secondary | UL electromyographic analysis of muscle activation | Instrumental assessment of muscle activity during a reaching task | Up to six weeks |
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