NCT02439515

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

2.6 years

First QC Date

April 24, 2015

Last Update Submit

March 6, 2017

Conditions

Stroke

Keywords

post-acute strokefunctional electrical stimulationbiofeedbackbalancecyclingrehabilitationgait

Outcome Measures

Primary Outcomes (1)

  • 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.

    "6 weeks"

Secondary Outcomes (10)

  • Gait speed

    "Day 0", "3 weeks", "6 months+6 weeks"

  • Aerobic capacity/endurance during gait assessed by 6-minute walking test

    "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"

  • Motor power of the paretic lower extremity assessed by Motricity Index

    "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"

  • Trunk Control assessed by Trunk Control Test

    "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"

  • Abilities during activities of daily life assessed by Functional Independence Measure

    "Day 0", "3 weeks", "6 weeks", "6 months+6 weeks"

  • +5 more secondary outcomes

Study Arms (2)

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.

Device: CyclingDevice: BalanceOther: Standard physical therapy

Usual Care

ACTIVE COMPARATOR

It consists of 30 daily sessions of standard physical therapy. Each session last about 90 minutes.

Other: Standard physical therapy

Interventions

CyclingDEVICE

Voluntary cycling augmented by electrical stimulation and biofeedback

Also known as: MOTOmed, Reck GmbH, PowerForce system, Radlabor GmbH, RehaStim; Hasomed GmbH
Biofeedback training
BalanceDEVICE

Balance control exercises with visual biofeedback

Also known as: Balance board basic™, NeuroCom® International, Inc.
Biofeedback training
Standard physical therapyOTHER

It consists of stretching, muscular conditioning, exercises for trunk control, standing, and walking training, and upper limb rehabilitation.

Biofeedback trainingUsual Care

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituti Clinici e Scientifici Maugeri

Lissone, Monza Brianza, 20851, Italy

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22514205BACKGROUND

  • 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.

    PMID: 21861930BACKGROUND

  • 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.

    PMID: 21372309BACKGROUND

  • 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.

    PMID: 32106874DERIVED

  • 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.

    PMID: 31556542DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Recruitment Detection, Audiologic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hearing TestsDiagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Simona Ferrante, PhD

    Politecnico di Milano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Ferrante, PhD

CONTACT

+390223999004simona.ferrante@polimi.it

Emilia Ambrosini, PhD

CONTACT

+390223999509emilia.ambrosini@polimi.it

Study Design

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

Study Record Dates

First Submitted

April 24, 2015

First Posted

May 8, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2017

Study Completion

October 1, 2017

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations

IT(1)