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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Stroke, Acute; Femur Fracture
• Intervention / Treatment: Other: Novel locomotion treatment: curved-walking training; Other: Standard physical therapy; Other: Standard locomotion treatment: straight-walking training

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giorgio Ferriero; Phone Number: 00390394657259; Email: giorgio.ferriero@icsmaugeri.it

Study Locations

• Italy
  • Monza E Brianza
    • Lissone, Monza E Brianza, Italy, 20851
      • Recruiting
      • Istituti Clinici Scientifici Maugeri Spa, Scientific Institute of Lissone
      • Contact: Giorgio Ferriero; Email: giorgio.ferriero@icsmaugeri.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Novel treatment, curved-walking training; 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; 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); Other: Standard physical therapy; 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.
ACTIVE_COMPARATOR: Usual care; 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 physical therapy; 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.; Other: Standard locomotion treatment: straight-walking training; It consists of 30 minutes of locomotion training on straight trajectories, as typically proposed during traditional gait rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 10 meter walk test (10MWT)	Time (seconds) needed by patients to walk for 10 meters	Baseline, 7 weeks, 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
curved-walking test	Time (seconds) needed to complete the "S" curved trajectory (7.53 m)	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.	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.	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.	Baseline, 7 weeks, 20 weeks
Pain Numerical Rating Scale	Pain perceived on 11 levels (0-10)	Baseline, 7 weeks, 20 weeks
Short Form Healthy Survey SF-36	Healthy status investigated in 36 questions	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.	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.	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.	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	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)	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).	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).	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)	Baseline, 7 weeks, 20 weeks

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA
• Collaborators: Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
• Investigators: Principal Investigator: Giorgio Ferriero, PhD, Istituti Clinici Scientifici Maugeri Spa, Scientific Institute of Lissone

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (ACTUAL): June 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: lower limb; gait rehabilitation; curved walking training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Fractures, Bone; Wounds and Injuries; Leg Injuries; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Stroke; Femoral Fractures; Parkinson Disease
• Other Study ID Numbers: 2152CE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No