Assessment of the Rehabilitative Effects of Curved-walking Training in Stroke, Parkinson and Orthopaedic Populations

NCT03545477 | Unknown

• 1 other identifier: 2152CE
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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 on straight-walking trajectories, e.g. Timed Up and Go (TUG), 10 meters walking test (10mWT). 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

Keywords

gait rehabilitation; curved walking training; lower limb

Outcome Measures

Primary Outcomes (1)

• Change in 10 meter walk test (10MWT)

  Time (seconds) needed by patients to walk for 10 meters

  Baseline, 7 weeks, 20 weeks

Secondary Outcomes (14)

• curved-walking test

  Baseline, 7 weeks, 20 weeks

• Timed Up and Go (TUG)

  Baseline, 7 weeks, 20 weeks

• Curved Timed Up and Go

  Baseline (test), day 2 (retest), 7 weeks, 20 weeks

• Balance test

  Baseline, 7 weeks, 20 weeks

• Pain Numerical Rating Scale

  Baseline, 7 weeks, 20 weeks

Study Arms (2)

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.

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.

Other: Standard locomotion treatment: straight-walking training; Other: Standard physical therapy

Interventions

Novel locomotion treatment: curved-walking training OTHER

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)

Novel treatment, curved-walking training

Standard locomotion treatment: straight-walking training OTHER

It consists of 30 minutes of locomotion training on straight trajectories, as typically proposed during traditional gait rehabilitation

Usual care

Standard physical therapy OTHER

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.

Novel treatment, curved-walking training; Usual care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy: collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri Spa, Scientific Institute of Lissone

Lissone, Monza E Brianza, 20851, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 20022995 BACKGROUND

• Courtine 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.

  PMID: 16328271 BACKGROUND

• Courtine 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.

  PMID: 12859351 BACKGROUND

• Godi 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.

  PMID: 24903003 BACKGROUND

MeSH Terms

Conditions

Stroke; Parkinson Disease; Femoral Fractures

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Giorgio Ferriero, PhD

  Istituti Clinici Scientifici Maugeri Spa, Scientific institute of Lissone

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgio Ferriero

CONTACT

00390394657259; giorgio.ferriero@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: June 4, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

IT (1)