Stroke, AcuteNCT03545477
Assessment of the Rehabilitative Effects of Curved-walking Training in Stroke, Parkinson and Orthopaedic Populations
A study testing Novel locomotion treatment: curved-walking training, Standard locomotion treatment: straight-walking training and Standard physical therapy in people with Stroke, Acute and Parkinson Disease, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
The recovery of walking ability is crucial to promote independence in daily living and is one of the major goal of neuromotor rehabilitation. Currently, standard rehabilitative programs are usually based on straight-walking training (SWT) and the assessment of their effects is performed through functional scales based… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute, Parkinson Disease, Femur Fracture
- What is being tested?
- Novel locomotion treatment: curved-walking training, Standard locomotion treatment: straight-walking training and Standard physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Jun 2028
- Phase
- Interventional
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-acute stroke patients experiencing a stroke less than 6 months before recruitment
- Idiopathic Parkinson Disease with disability level from moderate to severe (modified Hoehn \& Yahr scale 2.5-4)
- Femoral fracture, less than 1 month form surgery
Who cannot join
- Cognitive deficits (Mini Mental Scale Evaluation < 24)
- Hemineglect
- Modified Ashworth Scale of lower limb >2
- Unstable pharmacological treatment for Parkinson's Disease during the 15 days before the recruitment
- cardiopathic conditions
- metabolic conditions (e.g. dialysis) that prevent patients from aerobic training
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- Previous history of major neurological, vascular, musculoskeletal disorders
- Body Mass Index > 30 Kg/m2
- Invasive pharmacological treatment or surgery for Parkinson's disease
- lower limb pain (VAS >3)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituti Clinici Scientifici Maugeri Spa, Scientific Institute of Lissone
Lissone, Monza E Brianza, 20851
Giorgio Ferriero, giorgio.ferriero@icsmaugeri.it
About this study
The recovery of walking ability is crucial to promote independence in daily living and is one of the major goal of neuromotor rehabilitation.
Currently, standard rehabilitative programs are usually based on straight-walking training (SWT) and the assessment of their effects is performed through functional scales based on straight-walking trajectories, e.g. Timed Up and Go (TUG), 10 meters walking test (10mWT).
Read more
Curved-walking training (CWT) may be interesting to provide an ecological and challenging context during rehabilitation. Indeed, CWT is based on demanding neural processes that drive an asymmetrical contribution at lower limb level, challenging balance ability and complex adaptation such as body weight shifting in response to centrifugal force and production of different step lengths.
Up to now, literature has investigated CWT in healthy adults in terms of muscular activation, kinematics and kinetics of the movement. Results showed that CWT needs a different biomechanical strategy with respect to SWT. Nevertheless CWT has not been investigated in pathological adults.
The present study aims at assessing the effectiveness of a rehabilitative physical therapy based on CWT with respect to traditional SWT for the recovery of locomotor abilities in neurological and orthopaedic patients.
The hypothesis is that a training based on curved-walking is ecologically meaningful and may be superior with respect to standard training in improving balance, walking abilities, and independence in activity of daily live of patients.
A secondary aim of the project is to propose an innovative functional scale based on the timed up and go on curved trajectory (CTUG), and to determine its reliability and responsiveness, establishing the minimum Detectable Change (MDC) and the Minimal Clinically Important Difference (MCID).
A single-blind randomized controlled study is being carried out on three different populations:
- Post-acute stroke patients
- Idiopathic Parkinson Disease
- Femoral fracture
A healthy group is also being recruited to provide reference values of CTUG. For each of the three populations, subjects are randomized into two groups. The experimental one performs a novel rehabilitative program composed by a 30-minute training on curved trajectory ("S" trajectory composed by two semicircle with a radius of 1.2 m) in addition to usual care. The control group performs an equal dose of traditional treatment on straight trajectories.
Both groups undergo 20 90-minutes sessions of training (three times a week for seven weeks).
Participants are evaluated at baseline (T0), after training (T1), and at a three-months follow-up visit (T2).
The primary outcome measure is the 10mWT (minimal clinically important difference of 0.16 m/s identified by Tilson and colleagues). On the basis of this measure, a sample size of 70 subjects for each population was computed.
- Conditions
- Stroke, Acute, Parkinson Disease, Femur Fracture
- Being tested
- Novel locomotion treatment: curved-walking training, Standard locomotion treatment: straight-walking training, Standard physical therapy
- Keywords
- gait rehabilitation, curved walking training, lower limb
- Medical subject headings
- Stroke, Parkinson Disease, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel locomotion treatment: curved-walking trainingOther
Each training session is comprehensive of a 30-minute walking training on curved trajectory ("S" trajectory composed by two semicircle with a radius of 1.2 m)
Standard locomotion treatment: straight-walking trainingOther
It consists of 30 minutes of locomotion training on straight trajectories, as typically proposed during traditional gait rehabilitation
Standard physical therapyOther
It consists of 60 minutes of stretching, muscular conditioning and coordination,postural exercises for trunk control, standing, functional exercies and upper limb rehabilitation, customized on patient's need.
| Study group | Role | What they receive |
|---|---|---|
| Novel treatment, curved-walking training | Experimental | It consists of 20 sessions of training (three times a week for seven weeks) composed by standard physical therapy and a novel approach to locomotion rehabilitation based on curved-walking training. Each session lasts about 90 minutes. Receives: Other: Novel locomotion treatment: curved-walking training; Other: Standard physical therapy |
| Usual care | Active comparator | It consists of 20 sessions of training (three times a week for seven weeks) of standard physical therapy and conventional straight-walking training. Each session lasts about 90 minutes. Receives: Other: Standard locomotion treatment: straight-walking training; Other: Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10 meter walk test (10MWT)
Time (seconds) needed by patients to walk for 10 meters
Measured: Baseline, 7 weeks, 20 weeks
Secondary outcomes (14)
curved-walking test
Time (seconds) needed to complete the "S" curved trajectory (7.53 m)
Measured: Baseline, 7 weeks, 20 weeks
Timed Up and Go (TUG)
Time (seconds) needed to the patient to stand up upon therapist's command, walk 3 meters, turn around, walk back to the chair and sit down.
Measured: Baseline, 7 weeks, 20 weeks
Curved Timed Up and Go
Time (seconds) needed to the patient to stand up upon therapist's command, walk 3 meters following the curved trajectory, turn around, walk back on the curved trajectory to the chair and sit down.
Measured: Baseline (test), day 2 (retest), 7 weeks, 20 weeks
Balance test
Balance performance assessed by Balance test. Postural stability is evaluated using the commercial balance board Balance Master basicTM, NeuroCom® International, Inc. Assessments evaluate the postural sways during upright stance both with eyes open and closed; the limits of stability in different directions (forward, backward, right, and left); and the capability to shift the weight both left/right and forward/backward.
Measured: Baseline, 7 weeks, 20 weeks
Pain Numerical Rating Scale
Pain perceived on 11 levels (0-10)
Measured: Baseline, 7 weeks, 20 weeks
Short Form Healthy Survey SF-36
Healthy status investigated in 36 questions
Measured: Baseline, 7 weeks, 20 weeks
Falls Efficacy Scale (FES)
Risk of falls evaluated with 10 elements, each scored from 0 to 10. A total score higher than 70 suggests fear of falls.
Measured: Baseline, 7 weeks, 20 weeks
Global Perceived Effect (GPE) for patients
Perceived effectiveness of training for patients. A score from 1 (significantly improved) to 7 (significantly worsened) is assigned.
Measured: 7 weeks
Global Perceived Effect (GPE) for physiotherapists
Perceived effectiveness of training for physiotherapists. A score from 1 (significantly improved) to 7 (significantly worsened) is assigned.
Measured: 7 weeks
Motricity Index (MI)
Functional ability of limb - post-stroke population only. The quality of different limb movement are scored from 0 to 33 points, with a total score of 100 for each limb
Measured: Baseline, 7 weeks, 20 weeks
39-Item Parkinson's Disease Questionnaire (PDQ-39)
Quality of life questionnaire - Parkinson's Disease only. The questionnaire is based on 39 questions and the total score ranges from 0% (no difficulty) to 100% (maximum level of difficulty)
Measured: Baseline, 7 weeks, 20 weeks
Tampa Scale for Kinesiophobia (TSK)
Fear of movement - Parkinson's Disease only. Score ranges from 13 (no fear) to 52 (maximum fear).
Measured: Baseline, 7 weeks, 20 weeks
Unified parkinson's Disease Rating Scale (UPDRS)
Parkinson's Disease prognosis information - Parkinson's Disease only. Score ranges from 0 (normal) to 199 (severe impairment).
Measured: Baseline, 7 weeks, 20 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Physical functionality, pain and stiffness - post-femoral fracture only. Its score ranges from 0 (high healthy status) to 100 (low healthy status)
Measured: Baseline, 7 weeks, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
- Responsible party
- Sponsor
- Investigators
- Giorgio Ferriero, PhD, Principal investigator, Istituti Clinici Scientifici Maugeri Spa, Scientific institute of Lissone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545477
- Sponsor's protocol ID
- 2152CE
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2018
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tilson JK, Sullivan KJ, Cen SY, Rose DK, Koradia CH, Azen SP, Duncan PW; Locomotor Experience Applied Post Stroke (LEAPS) Investigative Team. Meaningful gait speed improvement during the first 60 days poststroke: minimal clinically important difference. Phys Ther. 2010 Feb;90(2):196-208. doi: 10.2522/ptj.20090079. Epub 2009 Dec 18.
PubMed 20022995Courtine G, Papaxanthis C, Schieppati M. Coordinated modulation of locomotor muscle synergies constructs straight-ahead and curvilinear walking in humans. Exp Brain Res. 2006 Apr;170(3):320-35. doi: 10.1007/s00221-005-0215-7. Epub 2005 Nov 19.
PubMed 16328271Courtine G, Schieppati M. Human walking along a curved path. I. Body trajectory, segment orientation and the effect of vision. Eur J Neurosci. 2003 Jul;18(1):177-90. doi: 10.1046/j.1460-9568.2003.02736.x.
PubMed 12859351Godi M, Turcato AM, Schieppati M, Nardone A. Test-retest reliability of an insole plantar pressure system to assess gait along linear and curved trajectories. J Neuroeng Rehabil. 2014 Jun 5;11:95. doi: 10.1186/1743-0003-11-95.
PubMed 24903003