Clinical trial NCT02439515: Fall Prevention and Locomotion Recovery in Post-stroke Patients: A Multimodal Training
Official title: Fall Prevention and Locomotion Recovery in Post-stroke Patients: A Multimodal Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: post-acute stroke
functional electrical stimulation
biofeedback
balance
cycling
rehabilitation
gait
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
First posted: 2015-05-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* neurological impairment (Mini mental scale \<24)
* presence of other neurological diseases
* spatial hemineglect
* cardiac pacemakers
* allergy to electrodes
* an inability to tolerate electrical stimulation.

Primary outcomes:
measure: Gait Speed
timeFrame: "6 weeks"
Secondary outcomes:
measure: Gait speed
timeFrame: "Day 0", "3 weeks", "6 months+6 weeks"
measure: Aerobic capacity/endurance during gait assessed by 6-minute walking test
timeFrame: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
measure: Motor power of the paretic lower extremity assessed by Motricity Index
timeFrame: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
measure: Trunk Control assessed by Trunk Control Test
timeFrame: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
measure: Abilities during activities of daily life assessed by Functional Independence Measure
timeFrame: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
measure: Risk of fall assessed by Fall Efficacy Scale
timeFrame: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
measure: Balance control assessed by Berg Balance Scale
timeFrame: "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"
measure: Patient's perception of the effect of the intervention assessed by Global Perceived Effect
timeFrame: "6 weeks"
measure: Pedaling performance assessed by Pedaling test
timeFrame: "Day 0", "3 weeks","6 months+6 weeks"
measure: Balance performance assessed by Balance test
timeFrame: "3 weeks", "6 weeks", "6 months+6 weeks"
Other outcomes:
Locations:
city: Lissone
country: Italy
facility: Istituti Clinici e Scientifici Maugeri
state: Monza Brianza
Study officials:
affiliation: Politecnico di Milano
name: Simona Ferrante, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.