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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
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)
It consists of 30 minutes of locomotion training on straight trajectories, as typically proposed during traditional gait rehabilitation
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.
Istituti Clinici Scientifici Maugeri Spa, Scientific Institute of Lissone
Lissone, Monza E Brianza, Italy
RECRUITINGChange in 10 meter walk test (10MWT)
Time (seconds) needed by patients to walk for 10 meters
Time frame: Baseline, 7 weeks, 20 weeks
curved-walking test
Time (seconds) needed to complete the "S" curved trajectory (7.53 m)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 7 weeks, 20 weeks
Pain Numerical Rating Scale
Pain perceived on 11 levels (0-10)
Time frame: Baseline, 7 weeks, 20 weeks
Short Form Healthy Survey SF-36
Healthy status investigated in 36 questions
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: Baseline, 7 weeks, 20 weeks
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