Fall Prevention and Locomotion Recovery in Post-stroke Patients: A Multimodal Training
NCT ID: NCT02439515
Last Updated: 2017-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2014-12-31
2017-10-31
Brief Summary
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A single-blind randomized controlled study is carried out. Participants are post-acute stroke patients experiencing a first stroke less than 6 months before recruitment, with an adult age, a low level of spasticity of the leg muscles (Modified Ashworth scale \<2), no limitations at hip, knee, and ankle joints, and able to sit up to 30 minutes. Subjects are randomized to one of two groups, one performing the novel rehabilitative program in addition to usual care (experimental group), and one performing usual care alone (control group).
The experimental program consists of 15 sessions of FES-supported voluntary cycling training followed by 15 sessions of balance training. Both cycling and balance training are supported by a visual biofeedback in order to maximize patients' involvement in the exercise and are performed in addition to usual care.
The control group is involved in standard physical therapy which includes stretching, muscular conditioning, exercises for trunk control, standing, and walking training, and upper limb rehabilitation.
Both training programs last 6 weeks and patients are trained daily for about 90 minutes. Cycling and balance training last about 20 minutes; thus, patients in the experimental group perform only about 70 minutes of usual care.
Participants are evaluated at baseline (T1), after the end of the cycling training or after 3 weeks of usual care (post-treatment, T2), after the end of the whole intervention (post-treatment, T3), and about 6 months after the end of the intervention (follow-up, T4).
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Detailed Description
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The cycling training is performed on a motorized cycle-ergometer (MOTOmed, Reck GmbH) equipped with force sensors mounted at the base of the cranks (PowerForce system, Radlabor GmbH). The acquired force signals are displayed to the subjects who are asked to achieve a symmetrical involvement of the two legs. To deliver FES, a current-controlled 8-channel stimulator (RehaStim; Hasomed GmbH) is used and surface electrodes are applied in a bipolar configuration on the quadriceps, hamstrings, gastrocnemius lateralis, and tibialis anterior of both legs. Rectangular biphasic pulses with a pulse width of 400 μs and a stimulation frequency of 20 Hz are adopted. The stimulus intensity is set on each muscle the first day of training: for the paretic muscles values well tolerated by the subject and able to produce visibly good muscle contractions are identified, whereas for the healthy side lower values just above the sensory threshold are used. The stimulation timing is synchronized to the cycling movement according to physiological stereotyped activation patterns.
The balance training is performed during upright stance using a balance board (Balance board basic™, NeuroCom® International, Inc.). Subjects are asked to keep still or move their center of pressure following a target displayed on a screen in front of them.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Biofeedback training
It consists of 15 daily sessions of voluntary cycling training augmented by functional electrical stimulation (FES) followed by 15 daily sessions of balance training (multimodal biofeedback training). Both cycling and balance training are supported by a visual biofeedback and last about 20 minutes.
In addition to cycling or balance training, subjects perform standard physical therapy in order to reach 90 minutes of training per day.
Cycling
Voluntary cycling augmented by electrical stimulation and biofeedback
Balance
Balance control exercises with visual biofeedback
Standard physical therapy
It consists of stretching, muscular conditioning, exercises for trunk control, standing, and walking training, and upper limb rehabilitation.
Usual Care
It consists of 30 daily sessions of standard physical therapy. Each session last about 90 minutes.
Standard physical therapy
It consists of stretching, muscular conditioning, exercises for trunk control, standing, and walking training, and upper limb rehabilitation.
Interventions
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Cycling
Voluntary cycling augmented by electrical stimulation and biofeedback
Balance
Balance control exercises with visual biofeedback
Standard physical therapy
It consists of stretching, muscular conditioning, exercises for trunk control, standing, and walking training, and upper limb rehabilitation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* low level of spasticity of the leg muscles (Modified Ashworth scale \<2)
* no limitations at hip, knee, and ankle joints
* able to sit up to 30 minutes
Exclusion Criteria
* presence of other neurological diseases
* spatial hemineglect
* cardiac pacemakers
* allergy to electrodes
* an inability to tolerate electrical stimulation.
18 Years
85 Years
ALL
No
Sponsors
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Politecnico di Milano
OTHER
Fondazione Salvatore Maugeri
OTHER
Responsible Party
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Simona Ferrante
PhD
Principal Investigators
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Simona Ferrante, PhD
Role: PRINCIPAL_INVESTIGATOR
Politecnico di Milano
Locations
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Istituti Clinici e Scientifici Maugeri
Lissone, Monza Brianza, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Ambrosini E, Ferrante S, Ferrigno G, Molteni F, Pedrocchi A. Cycling induced by electrical stimulation improves muscle activation and symmetry during pedaling in hemiparetic patients. IEEE Trans Neural Syst Rehabil Eng. 2012 May;20(3):320-30. doi: 10.1109/TNSRE.2012.2191574. Epub 2012 Apr 13.
Ferrante S, Ambrosini E, Ravelli P, Guanziroli E, Molteni F, Ferrigno G, Pedrocchi A. A biofeedback cycling training to improve locomotion: a case series study based on gait pattern classification of 153 chronic stroke patients. J Neuroeng Rehabil. 2011 Aug 24;8:47. doi: 10.1186/1743-0003-8-47.
Ambrosini E, Ferrante S, Pedrocchi A, Ferrigno G, Molteni F. Cycling induced by electrical stimulation improves motor recovery in postacute hemiparetic patients: a randomized controlled trial. Stroke. 2011 Apr;42(4):1068-73. doi: 10.1161/STROKEAHA.110.599068. Epub 2011 Mar 3.
Ambrosini E, Parati M, Peri E, De Marchis C, Nava C, Pedrocchi A, Ferriero G, Ferrante S. Changes in leg cycling muscle synergies after training augmented by functional electrical stimulation in subacute stroke survivors: a pilot study. J Neuroeng Rehabil. 2020 Feb 27;17(1):35. doi: 10.1186/s12984-020-00662-w.
Ambrosini E, Peri E, Nava C, Longoni L, Monticone M, Pedrocchi A, Ferriero G, Ferrante S. A multimodal training with visual biofeedback in subacute stroke survivors: a randomized controlled trial. Eur J Phys Rehabil Med. 2020 Feb;56(1):24-33. doi: 10.23736/S1973-9087.19.05847-7. Epub 2019 Sep 26.
Other Identifiers
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GR-2010-2312228-SF
Identifier Type: -
Identifier Source: org_study_id
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