StrokeNCT02439515
Fall Prevention and Locomotion Recovery in Post-stroke Patients: A Multimodal Training
A study testing Cycling, Balance and Standard physical therapy in people with Stroke, run by Fondazione Salvatore Maugeri at 1 site in Italy.
Trial summary
The study proposes a novel rehabilitative program for the recovery of locomotor abilities in post-acute stroke patients. The hypothesis is that a rehabilitative program which involves a biofeedback cycling training combining voluntary effort and Functional Electrical Stimulation (FES) of the leg muscles, and a… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Cycling, Balance and Standard physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2014to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post-acute stroke patients experiencing a first stroke (both ischemic or hemorrhagic) less than 6 months before recruitment
- 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
Who cannot join
- neurological impairment (Mini mental scale <24)
- presence of other neurological diseases
- spatial hemineglect
- cardiac pacemakers
- allergy to electrodes
- an inability to tolerate electrical stimulation.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituti Clinici e Scientifici Maugeri
Lissone, Monza Brianza, 20851
Giorgio Ferriero, PhD, +390394657259, giorgio.ferriero@icsmaugeri.it
Emilia Ambrosini, PhD, +390223999509, emilia.ambrosini@polimi.it
About this study
The study proposes a novel rehabilitative program for the recovery of locomotor abilities in post-acute stroke patients. The hypothesis is that a rehabilitative program which involves a biofeedback cycling training combining voluntary effort and Functional Electrical Stimulation (FES) of the leg muscles, and a biofeedback balance training is superior to usual care in improving walking abilities, disability, motor performance, and independence of post-acute stroke patients. The innovative approach is to investigate whether interventions which do not directly involve locomotor functions but movements similar in terms of kinematic patterns and neural commands (e.g. pedaling), or aimed at recovering an essential prerequisite for walking, such as postural control during upright stance, may improve and/or accelerate the recovery of walking abilities.
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).
Read more
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).
Read the detailed description
More details on the experimental training program are here provided.
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
- Stroke
- Being tested
- Cycling, Balance, Standard physical therapy
- Keywords
- post-acute stroke, functional electrical stimulation, biofeedback, balance, cycling, rehabilitation, gait
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclingDevice
Also called MOTOmed, Reck GmbH, PowerForce system, Radlabor GmbH, RehaStim; Hasomed GmbH
Voluntary cycling augmented by electrical stimulation and biofeedback
BalanceDevice
Also called Balance board basic™, NeuroCom® International, Inc.
Balance control exercises with visual biofeedback
Standard physical therapyOther
It consists of stretching, muscular conditioning, exercises for trunk control, standing, and walking training, and upper limb rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback training | Experimental | 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. Receives: Device: Cycling; Device: Balance; Other: Standard physical therapy |
| Usual Care | Active comparator | It consists of 30 daily sessions of standard physical therapy. Each session last about 90 minutes. Receives: Other: Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
Subjects are asked to walk three times at self-selected speed over the GaitRite mat using their walking aid (if any) or receiving the needed assistance. Spatial-temporal parameters are evaluated using the GaitRite software.
Measured: "6 weeks"
Secondary outcomes (10)
Gait speed
Subjects are asked to walk three times at self-selected speed over the GaitRite mat using their walking aid (if any) or receiving the needed assistance. Spatial-temporal parameters are evaluated using the GaitRite software.
Measured: "Day 0", "3 weeks", "6 months+6 weeks"
Aerobic capacity/endurance during gait assessed by 6-minute walking test
Subjects are asked to walk along a rectilinear corridor for 6 minutes. The distance covered is measured.
Measured: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
Motor power of the paretic lower extremity assessed by Motricity Index
Italian version; Only leg-subscale of the paretic side
Measured: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
Trunk Control assessed by Trunk Control Test
Italian version
Measured: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
Abilities during activities of daily life assessed by Functional Independence Measure
Italian version
Measured: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
Risk of fall assessed by Fall Efficacy Scale
Italian version
Measured: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
Balance control assessed by Berg Balance Scale
Italian version
Measured: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
Patient's perception of the effect of the intervention assessed by Global Perceived Effect
Italian version
Measured: "6 weeks"
Pedaling performance assessed by Pedaling test
A pedaling test is performed on the motorized cycle-ergometer to measure the force produced by the two sides during voluntary cycling as well as electromyography activations of the main lower limb muscles. Subjects are asked to pedal at four difference target pace (20 RPM, 30 RPM, 40 RPM, and 50 RPM), while the ergometer motor maintains a constant cadence of 10 RPM less than the target. A visual numerical cadence indicator and a metronome help the subjects to keep the constant cadence.
Measured: "Day 0", "3 weeks","6 months+6 weeks"
Balance performance assessed by Balance test
Postural stability is evaluated using the commercial balance board exploited in the experimental intervention program (Balance board basic™, NeuroCom® International, Inc.). Pre-defined assessments are used to evaluate the postural sways during upright stance both with eyes open and closed; the limits of stability in all directions (forward, backward, right, and left); and the capability to shift the weight both left/right and forward/backward.
Measured: "3 weeks", "6 weeks", "6 months+6 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano
- Responsible party
- Principal investigator, Simona Ferrante, Politecnico di Milano
- Investigators
- Simona Ferrante, PhD, Principal investigator, Politecnico di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439515
- Sponsor's protocol ID
- GR-2010-2312228-SF
- Status last verified
- Mar 2017
- First submitted
- 24 Apr 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22514205Ferrante 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.
PubMed 21861930Ambrosini 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.
PubMed 21372309Ambrosini 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.
PubMed 32106874Ambrosini 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.
PubMed 31556542
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall Prevention and Locomotion Recovery in Post-stroke Patients: A Multimodal Training
- ClinicalTrials.gov ID
- NCT02439515
- Acronym / sponsor ID
- GR-2010-2312228-SF
- Conditions
- Stroke
- Keywords
- post-acute stroke, functional electrical stimulation, biofeedback, balance, cycling, rehabilitation, gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Collaborators
- Politecnico di Milano
- Study start
- Dec 2014
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study proposes a novel rehabilitative program for the recovery of locomotor abilities in post-acute stroke patients. The hypothesis is that a rehabilitative program which involves a biofeedback cycling training combining voluntary effort and Functional Electrical Stimulation (FES) of the leg muscles, and a biofeedback balance training is superior to usual care in improving walking abilities, disability, motor performance, and independence of post-acute stroke patients. The innovative approach is to investigate whether interventions which do not directly involve locomotor functions but movements similar in terms of kinematic patterns and neural commands (e.g. pedaling), or aimed at recovering an essential prerequisite for walking, such as postural control during upright stance, may improve and/or accelerate the recovery of walking abilities.
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).
Detailed description
More details on the experimental training program are here provided.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback training | Experimental | Device: Cycling, Device: Balance, Other: Standard physical therapyIt 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. |
| Usual Care | Active comparator | Other: Standard physical therapyIt consists of 30 daily sessions of standard physical therapy. Each session last about 90 minutes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- post-acute stroke patients experiencing a first stroke (both ischemic or hemorrhagic) less than 6 months before recruitment
- 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
Key exclusion criteria (6 listed)
- neurological impairment (Mini mental scale <24)
- presence of other neurological diseases
- spatial hemineglect
- cardiac pacemakers
- allergy to electrodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclingAlso: MOTOmed, Reck GmbH, PowerForce system, Radlabor GmbH, RehaStim; Hasomed GmbHVoluntary cycling augmented by electrical stimulation and biofeedback | Device | Biofeedback training |
| BalanceAlso: Balance board basic™, NeuroCom® International, Inc.Balance control exercises with visual biofeedback | Device | Biofeedback training |
| Standard physical therapyIt consists of stretching, muscular conditioning, exercises for trunk control, standing, and walking training, and upper limb rehabilitation. | Other | Biofeedback training, Usual Care |
Primary outcome
Gait Speed
Time frame: "6 weeks"
Subjects are asked to walk three times at self-selected speed over the GaitRite mat using their walking aid (if any) or receiving the needed assistance. Spatial-temporal parameters are evaluated using the GaitRite software.
10 secondary outcomes
Gait speed
Time frame: "Day 0", "3 weeks", "6 months+6 weeks"
Aerobic capacity/endurance during gait assessed by 6-minute walking test
Time frame: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
Motor power of the paretic lower extremity assessed by Motricity Index
Time frame: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
Trunk Control assessed by Trunk Control Test
Time frame: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
Abilities during activities of daily life assessed by Functional Independence Measure
Time frame: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
Risk of fall assessed by Fall Efficacy Scale
Time frame: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
Balance control assessed by Berg Balance Scale
Time frame: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
Patient's perception of the effect of the intervention assessed by Global Perceived Effect
Time frame: "6 weeks"
Pedaling performance assessed by Pedaling test
Time frame: "Day 0", "3 weeks","6 months+6 weeks"
Balance performance assessed by Balance test
Time frame: "3 weeks", "6 weeks", "6 months+6 weeks"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Background: PubMed 22514205Ambrosini 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.
- Background: PubMed 21861930Ferrante 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.
- Background: PubMed 21372309Ambrosini 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.
- Derived from this study: PubMed 32106874Ambrosini 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.
- Derived from this study: PubMed 31556542Ambrosini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simona Ferrante, PhD principal investigator
Politecnico di Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling, Balance and Standard physical therapy in people with Stroke, run by Fondazione Salvatore Maugeri at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simona Ferrante, PhD (+390223999004, simona.ferrante@polimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed (time frame: "6 weeks"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02439515, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.